11th International Conference of Drug Regulatory Authorities

Eleventh International Conference of Drug Regulatory Authorities (ICDRA)

World HealthOrganization

P R O C E E D I N G S


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Proceedings of theEleventhInternationalConference of DrugRegulatoryAuthorities (ICDRA)

16–19 February 2004Madrid, Spain

Spanish Agency for Medicinesand Health Products

World Health Organization


Objectives of theInternationalConference of DrugRegulatoryAuthorities (ICDRA)

• to promote collaborationbetween drug regulatoryauthorities

• to reach a consensus onmatters of interest

• to facilitate timely andadequate exchange ofinformation

• to discuss issues ofinternational relevance


ContentsPage

Opening ceremonyDr Ana Pastor, Minister of Health, Spain 1Dr LEE Jong-wook, Director-General,

World Health Organization 4Dr Zheng Xiaou, Commissioner, State Food and Drug

Administration, People‘s Republic of China 7

ProgrammeEleventh ICDRA programme overview 8Eleventh ICDRA Programme 10

Selected presentationsChallenges to regulators in establishing efficacy 16Role of regulators in improving the quality of

ethical outcomes 17Regulatory aspects of gene transfer medicinal products 21The need for informed consent in clinical research 22Challenges to regulators in ensuring safety monitoring 25Success factors in national pharmacovigilance

programmes 26How pharmacoepidemiology can improve

pharmacovigilance practice 27Assuring the safety and quality control of traditionalmedicines 30Regulation of herbal medicines in Nigeria 31Safety surveillance system for natural health products in

Canada 32Consumer/patient information on safe use of herbals 33


PageRecommendationsProgress report on Tenth ICDRA 34Regulatory aspects of access to medicines 34Strengthening of regulatory frameworks for medicinal

products 35Pharmacovigilance practices 35Pharmacopoeias in a changing regulatory environment 37Regulatory assessment of combination products 38Regulators, good clinical practice and ethics 38Public health vs. the marketplace 39Safety of herbal medicines 40Assuring quality and safety of blood products 41Human tissue: problems and challenges for regulators 42Regulatory tools for providing drug information 43Harmoniztion updates 43Promoting good regulatory practices 44Regulatory aspects of dsupply of quality medicines 45Implicatiuons of regulatory decisions for

pharmacoeconomics 46Current topics 47

List of participants 49

Presentations made during the conferencecan be found on the attached CD-ROM


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Opening Ceremony

Dr Ana PastorMinister of Health, Spain

Allow me to welcome participants to this Eleventh International Con-ference of Drug Regulatory Authorities (ICDRA) and to inaugurate thisimportant meeting which once again convenes all the world’s coun-tries, as represented by their drug regulatory agencies.

Before we begin our work, I should once again like to draw attentionto the heavy responsibility we bear. Our countries’ citizens trust thatwe are here to safeguard the use and availability of medicines and toenhance the unique opportunity for health that they represent. Thismakes it incumbent upon us to devote our best endeavours to drugregulation; these meetings sponsored by WHO are an exceptional op-portunity to learn from each other and to return home with renewedideas and enthusiasm.

I am convinced that meetings between people of different back-grounds, cultures and races are a valuable and hugely enriching op-portunity which we must not neglect. We have enthusiasticallydrawn up a conference programme which we believe will help to ce-ment many bonds. Also, a visit to Toledo, just over 100 kilometresfrom Madrid, is planned. Toledo is a thousand-year old city brimmingwith history and artistic treasures. It is also a city that for many yearswas a land of tolerance and diversity, and where different cultures en-gaged in peaceful dialogue and prospered together.

This is also an ideal moment to congratulate participants of the pre-ICDRA meeting which focused on the very serious problem of coun-terfeit drugs and the ever-more-important task of coordinating in-spection activities. I am confident that the conclusions reached willhelp to improve the situation and to provide the most appropriate re-sponse.


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Drug regulatory agencies have become a vital tool for public health.We are dealing with one of the most tightly controlled consumergoods of our time, in whatever part of the world. This is due to thenature of medicines themselves which, alongside their huge poten-tial benefits, carry risks – even when they are properly manufacturedand used. Reducing these risks as much as possible is a hugely com-plex and demanding task to which your agencies are devoting theirefforts.

The international conferences of drug regulatory authorities demon-strate a fine example of cooperation. We enthusiastically welcomethe efforts of the World Health Organization as a coordinator of ef-forts to achieve an ever-healthier world. There is no doubt that we allface ever more demanding challenges but the means of meetingthese are constantly improving. One of the fundamental features ofour time is the close connection between scientific considerationsand political decisions. We need to be capable of putting into practiceand focusing scientific and political considerations within a capacityto anticipate the future. This is becoming indispensable for regula-tory authorities in the light of the challenges which the future is sureto bring. If we wish to successfully perform our task, we need to keepclose track of scientific progress.

The conference programme will include many major issues withwhich we are concerned: these range from the specialized topic offixed dose combinations of drugs to the general and vital issue ofdrug monitoring. From pharmacopoeias to herbal medicines, fromdrugs derived from blood to new frontiers.

Undoubtedly, one of the main problems we shall address is that of ac-cess to drugs. It is an unfortunate fact of our world that there are un-acceptable differences preventing those in greatest need of essentialmedicines from obtaining them. However, the developed world can-not turn its back on whole regions in which living conditions are pre-carious and we must strive to achieve the ultimate objective of allow-ing all to benefit from the advantages of progress.

There are some countries in which 40% of young adults are infectedwith the human immunodeficiency virus and in which the number oforphans, now and in the future, is enormous. We can no longer disre-gard this problem. I call on a collective sense of humanitarian respon-sibility to fulfil the obligations of our common human destiny.Should we fail to do this, suffering will continue to spread throughoutthe world and we shall have failed in our task.


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It is impossible to guide health organizations towards new areas ofconcern without coordination or on the basis of only short-term poli-cies. The need is for a firm commitment by all the specialists and offi-cials concerned. This is a journey that we all have to make. The topicsmentioned above are a clear demonstration of this need. It is point-less to address them in disarray, and without the active involvementof our countries’ health professionals we shall undoubtedly fail. Oursis a time of enormous hope and potential. Thanks to the media andtechnical progress, we are all able to keep abreast, almost in real time,of the advances being made by science, and on many occasions it ispossible for us to make use of those advances, or at least to take theminto account when making decisions.

There are many of us who feel overwhelmed by the volume of infor-mation available to us. However, because we live in a world in whichwe will face an ever-growing volume of instantly-processed informa-tion, we are obliged to seek ways of accessing, analysing and apply-ing it. Striving to keep up with progress being made in each field is ademanding task for any specialist, and it is even more so for healthprofessionals. However, in order to overcome widespread prejudiceagainst new technology, we need to strengthen those features whichhelp to make health care more humane. There are excellent supportgroups for the chronically ill on the Internet together with informa-tion and medical consultation pages; at the same time, the new tech-nologies are helping to link specialists at the different levels of care.Perhaps we, as regulatory authorities, should also develop a tool toenable us to keep regularly in touch with our specialists.

For this reason, meetings between agencies are essential. Far fromthe indifference of the computer or the office desk, these meetingsgive us an opportunity not only to formally examine the issues athand, but also to meet those who have to deal with the same prob-lems. All of us have something to learn and something to teach .

This Conference will undoubtedly enable us to improve our knowl-edge and help to improve the health of our populations. By workingdiligently and rigorously in our specialized field – in this case thecomplex and fascinating world of medicines – we help to ensure thatfuture generations will enjoy a better world.

To achieve this, we need a world of peace. Without the right to peace,all other rights disappear and our achievements collapse. Develop-ment is impossible when violence prevails so that we must vigilantlymaintain our daily commitment to building culture and peace. I hopethat our conference proves to be a valuable opportunity for us and asuccess for all.


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Dr LEE Jong-wook, Director-GeneralWorld Health Organization

It is a pleasure to be here today for this important conference. Drugregulatory authorities around the world play a vitally important rolein ensuring the safety, quality and efficacy of medicines, blood prod-ucts, vaccines and biologicals. The greatest public health achieve-ments of our time have involved wide and effective coverage of im-munization and treatment. They would not have been possible with-out your efforts, and the world will need those efforts even more tomeet the challenges that lie ahead.

The increase in volume and complexity of trade in pharmaceuticalproducts continues to accelerate. Not only the products but the start-ing and intermediate materials used for making them are traded in-ternationally. Finished products, in their turn, are often repackagedand re-traded several times before they reach their end users. Be-cause speed can make the difference between success and failure intrade and in applying medicine, there is pressure to make regulatoryprocedures quick and minimal. Especially where there are demandsfor medicines on a large scale, at short notice, to fight an epidemic orsupport a campaign, manufacturers can find themselves under in-tense pressure to skip some of the mechanisms designed to ensuresafety and quality. In addition, patients and their carers are increas-ingly turning to the Internet for alternative treatments, lifestyledrugs or just cheaper medicines. This exposes them to products thatmay not have been subjected to national regulatory control. Thistrend combines to help substandard or counterfeit medicines circu-late more and more easily, presenting a growing threat to publichealth. Regulatory authorities increasingly find themselves in diffi-cult situations, with strong but conflicting demands coming fromgovernment, business and the public. All stakeholders need to make afull review of this situation and find new ways to tackle it. Your dis-cussions here this week can make a valuable contribution to thisprocess.

An initial step towards making drug regulation manageable interna-tionally is to enable more countries to have effective regulatory au-thorities. At present, only half of them do, and almost a third of thecountries in the world have no regulatory system at all. It is in thosecountries most in need of safe and affordable medicines that this lackof regulatory facilities is most apparent. The gap can be bridged inpart by making all existing regulatory information publicly available


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and easily accessible. This can save time and avoid duplication of ef-fort for regulators, prescribers, pharmacists, health workers and con-sumer groups.

Especially where medicines are being used to fight diseases that arekilling thousands, regulatory activities have to be made as cost-effec-tive as possible. In many cases, assessments made in other countriescan be valid where there is harmonization of regulatory require-ments. Harmonization can facilitate access and lower prices, and isdeveloping rapidly in some parts of the world. But, harmonizationlags far behind for multi-source generic drugs and these includemany of the affordable essential medicines.

In all countries, adverse drug reactions are a major concern. They arethe fifth leading cause of death in the USA, and elsewhere up to 17%of the health care budget is spent on dealing with them. A good phar-macovigilance system costs only about one dollar for every thousanddollars spent on the purchase of medicines. The challenges here in-clude preventing the adverse reactions that can be caused by unsafeherbal medicines, ensuring the safety of products derived from bloodand plasma and making an ever-expanding array of vaccines avail-able to those who need them. Regulation, in these and other areasyou will be discussing, requires the development of special expertise.

International negotiations, though slow and unpredictable, canpresent new opportunities to make safe and effective medicinesmore accessible. The World Trade Organization’s decision last August,on Paragraph 6 of the Doha Declaration on TRIPS and Public Health,has the potential to facilitate the export of affordable medicines tothe countries that need them most. Much depends on how this deci-sion is implemented in countries without their own pharmaceuticalproduction facilities. They need all the support we can give them,both through WHO and through your own agencies.

A catalyst and focus for many of the activities needed in this field isour current campaign to get three million people living with HIV indeveloping countries onto antiretroviral treatment by the end of2005. To assist countries in obtaining the products they need for this,we have established an AIDS Medicines and Diagnostics Service(AMDS). It builds on work carried out over a number of years by WHO,UNAIDS, UNICEF, the World Bank, and the Global Fund. Its aim is tobridge the treatment gap in developing countries. The AMDS is basedat WHO in Geneva and is run jointly with our UN partners.


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The AMDS will provide buyers with up-to-date information on thesources, prices and regulatory status of antiretrovirals. It will continueto purchase diagnostic tests as part of its bulk procurement schemeand will be keeping manufacturers informed of anticipated needs. Itwill also be working with you and your colleagues to support productspecification and registration, prequalification of antiretrovirals anddiagnostics, and quality assurance methods for local production. Thesame partnership also provides a mechanism to ensure safety, effi-cacy and quality through the prequalification of products for HIV, ma-laria and tuberculosis. It has already helped to make nearly 100 reli-able products available worldwide. Thanks to the support and exper-tise of many regulatory authorities around the world, this has be-come a highly effective and technically robust service.

During the twentieth century, technical innovation made an enor-mous contribution to improving the world’s health status. Progresshas continued for some tropical diseases such as African trypano-somiasis and visceral leishmaniasis, but for malaria and tuberculosisinnovation has fallen well behind current needs. The older medicinesare failing either because they encounter resistance or because theydo not meet present-day standards of safety. In many countries, evenwhere there are potential new products, regulators do not have thecapacity to assess their safety and efficacy.

Slow progress in developing malaria and tuberculosis medicines is amajor problem, and one that will benefit from your particular atten-tion during this week. Recently, the European Medicines EvaluationAgency has been authorized to advise on products for use outside Eu-rope. This is but one example of how regulators globally can helpcountries most in need.

To establish new drug regulatory authorities and strengthen thosethat are not yet working properly will require more of this kind of soli-darity, as well as innovative thinking and a realistic investment. Yourdiscussions during the next three days provide a valuable opportu-nity for sharing ideas and information on what works.

In conclusion, it is in the interests of everyone to have reliable na-tional and international drug regulatory systems. The health authori-ties, the health workers and the public cannot do without this assur-ance, nor can the pharmaceutical companies.

Your work can rightfully claim the wholehearted support of all con-cerned. You certainly have that of WHO and I wish you every successin your discussions here this week.


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Dr Zheng Xiaou,Commissioner, State Food and Drug Administration,People‘s Republic of China

As the representative of the host country which organized the TenthInternational Conference of Drug Regulatory Authorities in HongKong, SAR, China in June 2002, please allow me to express my thanksto the organizers of this Eleventh ICDRA — the Spanish Ministry ofHealth and World Health Organization — for inviting me to say a fewwords on behalf of the People‘s Republic of China.

With the dramatic changes in our environment and the developmentof science and technology, drug regulatory authorities encountermany new issues and challenges. For twenty years now, the ICDRAshave served as a forum for senior drug regulators to discuss regula-tory affairs, exchange views and identify the direction of future devel-opments.

We appreciate the efforts that the Spanish Agency fpr Medicines andHealthcare Products and WHO have made in the preparation of thisconference and the careful selection of various topics for discussion.We are very glad to participate in the ICDRA in Spain – a country witha long-standing history and splendid culture.

We look forward to fruitful discussion and dynamic exchange ofviews during the conference with an opportunity to clarify issues andchallenges that drug regulatory authorities are now facing. This willprovide us with ways to explore and improve harmonization, coop-eration and communication among different authorities. It is also ourwish to strengthen administration of drug regulation through effec-tive measures that ensure the safety, efficacy and quality of medi-cines while improving access and rational use of drugs.


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Opening session Plenary 1Progress reporton Tenth ICDRA

.Workshop 5-A

Plenary 2. Safety of herbal medicinesRegulatory aspects

of access to medicines Workshop 6-B Assuring quality and safety

of blood products

Workshop 7-CHuman tissue: problems

Plenary 3 & challenges for regulatorsStrengthening of

regulatory frameworks Workshop 8-Dfor medicinal products Regulatory tools for

providing drug information

Plenary 4 Plenary 5Pharmacovigilance Current topics

practices

Eleventh ICDRA Programme Overview

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Workshop 1-EPharmacopoeias in a Workshop 3-Ichanging regulatory Regulators, GCP and Ethics

environmentWorkshop 4-J

Workshop 2-F Public health needsRegulatory assessment of vs the marketplace

combination products

–––––––––––– ––––––––––––

Workshop 11-KWorkshop 9-G Regulatory aspects of

Harmonization updates supply of quality medicines

Workshop 10-H Workshop 12-LPromoting good Implications of regulatory

regulatory practices decisions forpharmacoeconomics

Keynote presentation: RecommendationsRegulatory challenges of and

pharmacogenetics Closing remarksand pharmacogenomics


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Eleventh ICDRA ProgrammeMONDAY 16 FEBRUARY

(Presentations made during theconference are provided on the attached CD-ROM)

Opening session09.00 - 10.30 at Hospital San Carlos

Dr Ana Pastor, Minister of Health, SpainDr LEE Jong-wook, Director-General, World Health OrganizationDr Carlos Lens, Director, Spanish Agency for Medicines and Health Products, SpainMr X. Zheng, Commissioner, State Food and Drug Administration, People‘s Republic of China

Plenary 1. Progress report on Tenth ICDRA11.00-12.30 at Hospital San Carlos

Introduction and overview of Tenth ICDRA : Dr Lam, Director,Department of Health, Hong Kong SAR, China

International implementation : Dr V. Lepakhin, Assistant Director-General, Health Technology and Pharmaceuticals, WHO

Country implementation : WHO Regional Advisers

Workshop 1-EPharmacopoeias in a changing regulatory environment14.30-16.00 at Hotel M. Angel

Moderators: Dr Ashwini Kumar, India and Dr Chiale, Argentina

Pharmacopoeial monographs vs. manufacturers’ specifications :Dr Vardulaki, Spain

Impurity profile specifications: repercussion of the new ICH guidancetext : Dr Wang Guorong, China

International harmonization : Need for international reference substances, PDG, regional harmonization efforts : Dr Gugu Mahlangu,Zimbabwe


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Workshop 2-F.Regulatory assessment of combination products14.30-16.00 at Hotel M. Angel

Moderators: Dr K. Woods, United Kingdom and Ms Maryam Hinds,Barbados

Regulatory approach to the fixed-dose combination products: newchallenges : Dr L. Slamet, Indonesia

BfArm thinking about fixed-dose combinations : Dr Christian Behles,Germany

Need for new clinical studies and fixed-dose combinations :Dr J. Molzon, USA

Combination drugs for public health needs – regulatory viewpoint :Dr Shabir Banoo, South Africa

Workshop 3-I. Regulators, GCP and Ethics16.30-18.00 at Hotel M. Angel

Moderators: Teresa Milan, Spain and Dr Y. Sohn, Republic of Korea

Role of regulators in improving the quality of ethical outcomes :Dr Chor Hiang Tan, Singapore

Vaccine Development, GCP & the Global Challenge :Dr Jesse Goodman, USA

GCP in Clinical Gene Therapy: the Role of the CPMP/Gene TherapyExpert Group : Dr Cichutek, EMEA

The need for informed consent in research : Dr P. Saidon, Argentina

Workshop 4-J. Public health needs vs the marketplace16.00 - 18.00 at Hotel M. Angel

Moderators: Mr Ben Botwe, Ghana, and Dr J. Lynvvig, Denmark

Orphan drugs legislation in the EU: lessons learned :Mr P. Weissenberg, T. Lonngren EMEA

The role of regulators in improving access to drugs for neglecteddiseases : Dr Ashwini Kumar, India

The challenges and implications of limited regulatory capacity :Dr Kristin Raudsepp, Estonia

How to get necessary public health products developed andauthorized : Mr J. Lisman, Netherlands

Medicines regulation in tourism-driven economies : Mr G. Requin,Mauritius


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TUESDAY 17 FEBRUARY

Plenary 2. Regulatory aspects of access to medicines09.00 - 10.30 at Hotel Miguel Angel

Moderators : Dr Rodrigo Salinas, Chile and Dr. Jose Félix Olalla, Spain

Fast track, orphan drugs, public health needs, distribution, supply :Dr Supachai Kunaratanapruk, Thailand

Innovation, patents : Dr R. Peterson, CanadaDistribution, supply and availability : Dr Per Roksvaag, NorwaySpanish experience in facilitating access to public health priority

drugs : Dr. Jose Félix Olalla, Spain

Workshop 5-A. Safety of herbal medicines11.00 - 12.30 at Hotel Miguel Angel

Moderators : Dr K. Keller, Germany, and Dr Ashwini Kumar, India

Safety monitoring : Dr Duc Vu, CanadaQuality issues contributing to safety : Dr R. Lin, ChinaRegulatory aspects of herbal medicines : Dr Dora Akunyili, NigeriaCustomer education and herbal medicines : Dr Rolf Spang,

Switzerland

Workshop 6-B. Assuring quality and safety of blood products

11.00 - 12.30 at Hotel Miguel Angel

Moderators : Dr J. Lower, Germany and Dr Hong-Ki Min,Republic of Korea

Plasma fractionation in Canada : Ms Julia Hill, CanadaIssues related to GMP : Dr C. Schaerer, SwitzerlandCountry Experience : Dr Beatriz MacDowell Soares, BrazilRound table discussion – Problems encountered in practice


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WEDNESDAY 18 FEBRUARY

Plenary 3. Strengthening of regulatory frameworks for medici-nal products09.00 - 10.30 at Hotel Miguel Angel

Moderator : Dr M. Limeres, Argentina

Regional initiatives, ASEAN : Dr Dato Che Zin, MalaysiaRegional initiatives, EU : Mr P. Weissenberg, EUGlobal Training Network : Dr H.K. Min, Republic of Korea

Workshop 7-C.Human tissue: problems and challenges for regulators11.00 - 12.30 at Hotel Miguel Angel

Moderators : Dr Davi Rumel, Brazil, and Dr Pierrette Zorzi, France

US Approach to the Regulation of Human Cell and Tissue-BasedProducts : Jill Warner, USA

Development of a comprehensive regulatory framework for thesafety of cells, tissues and organs for transplantation in Canada :Ms Julia Hill, Canada

FACT Creditation as a model of the Surveillance and Standard for theCanadian System : Dr Tony Giulvi, Canada

Issues in cells and tissues regulatory oversight in Brazil : Dr De FariaVilaca, Brazil

The development of cell & tissue based products, a regulatoryperspective : Dr Yeowon Sohn, Korea

Surveillance following cell and tissue transplantation in Spain :Dr Blanca Miranda, Spain

Workshop 8-D. Regulatory tools for providing drug information11.00 - 12.30 at Hotel Miguel Angel

Moderators: Dr J. Molzon, USA and Dr F. Garcia Alonso, Spain

Developing SPCs, the experience of a small authority :Pr A. Toumi, Tunisia

The Europharm project : Dr R. Santos Ivo, PortugalEMEA: transparency, information and communication :

Ms Arielle North, EMEAPublication Bias, Dr B. Beermann, Sweden


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Workshop 9-G. Harmonization updates14.30 - 16.00 at Hotel Miguel Angel

Moderators : Mr T. Lonngren, EMEA, and Dr John Lim, Singapore

New Horizons in Harmonization: report from ICH6 : Mr ShuichiKishida, Japan

Impact of ICH to non-ICH countries. Global Cooperation Group :Mr Mike Ward, Canada

Regional harmonization initiatives. SADAC countries experience :Dr Gugu Mahlangu, Zimbabwe

Role of WHO in regional harmonization initiatives. PANDRH :Ms Rosario D’Alessio, PAHO/AMRO

Workshop 10-H. Promoting good regulatory practices14.30 - 16.00 at Hotel M. Angel

Moderators : Dr Zheng Xiaoyu, China, and Dr R. Palop, Spain

Country experience : Dr Celeste Sanchez, CubaCountry experience: Mr B.K. Botwe, GhanaCountry experience: Ms Eishah Abdul Rahman, Malaysia

Workshop 11-K. Regulatory aspectsof supply of quality medicines16.30 - 18.00 at Hotel Miguel Angel

Moderators : Dr J. Molzon, USA and Dr J. Lim, Singapore

Quality considerations in bulk purchase: challenges for internationally valid specifications – stability data : Mr Rutendo Kuwana,Zimbabwe

GMP and inspection: future approaches and challenges : Dr T. Paal,Hungary

Supply of quality pharmaceutical starting materials : Dr J. Lisman,Netherlands

Workshop 12-L. Implications of regulatory decisionsfor pharmacoeconomics16.30 - 18.00 at Hotel Miguel Angel

Moderator : Pr A. Toumi, Tunisia

Lessons from pharmacoeconomic evaluations : Dr Carlos Lens, SpainThe role of regulators in reimbursement decisions : Dr A. Addis, ItalyRegulatory decisions and phamacoeconomics : Dr S. Tarragona,

Argentina


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THURSDAY 19 FEBRUARY

Plenary 4. Pharmacovigilance practices09.00 - 10.30 at Hospital San Carlos

Moderators : Dr S. Jessamine, New Zealand, and Dr Gugu Mahlangu,Zimbabwe

Factors for success in national pharmacovigilance programmes :Abida Haq, Malaysia

How pharmacoepidemiology and other methods of intensivemonitoring post approval can supplement spontaneous reporting:Francisco de Abajo, Spain

A model for introducing pharmacovigilance for new therapies forneglected diseases in developing countries- example of artemisinin derivatives : Mr. Henry Irunde, United Republic of Tanzania

The burden of assessing PSURS : Milan Smid, Czech Republic

Plenary 5. Current topics11.00 - 12.00 at Hospital San Carlos

Moderators : Professor A. Toumi, Tunisia and Dr T. Paal, Hungary

Keynote presentations and panel discussion14.00-15.00 at Hotel Miguel Angel

Moderator : Dr Carlos Lens

Regulatory challenges of pharmacogenetics and pharmacogenomics:impact for new and existing therapies

• Dr G. Kreutz, Germany• Dr Jesse Goodman, USA• Dr R. Peterson, Canada

Recommendations and closing remarks15.00 - 16.00 at Hotel Miguel Angel

Presented by Dr Carlos Lens, Spanish Agencyfor Medicines and Health Products, Spain


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Selected presentations*

Challenges to regulators in establishing efficacy

In recent years, there has been a substantial increase in the numberof clinical trials for biomedical research conducted in both developedand developing countries. As a result of sequencing of the genome,clinical research in potential therapies is likely to increase, while eventhe best-proven prophylactic, diagnostic, and therapeutic methodsmust continuously be challenged by research. Despite this situationand introduction of new clinical trial management processes andmethods, there is currently a lack of regulation of clinical trials inmany countries and non-medicinal product trials are rarely subject toregulatory oversight.

The abundance of alliances and partnerships between acadaemiaand the pharmaceutical and biotechnology industries has also givenrise to concern over the application of ethical and scientific principlesand the following issues are subject to current debate:

• the potential for conflict of interest;

• unethical patient recruitment practices;

• inadequacy of informed consent;

• lack of capacity to ensure ongoing monitoring of clinical trialsand adherence to principles of sound and ethical clinicalpractice; and

• poor reporting and management of adverse events.

For drug regulators, such trends in the conduct of clinical trialspresent special and urgent challenges, particularly in ensuring thatthe rights and health of patients and their communities are pro-tected. In their approval of clinical trials, regulatory bodies shouldlook not only at safety and efficacy of new products under investiga-tion but they must also pay attention to the general standards of care

* Slide-show presentations made during the conference are available on the attached CD-ROM.


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and safety of study subjects, in close collaboration with the appropri-ate ethical review committees and institutional review boards.

The increasing complexity of clinical trials presents further chal-lenges to regulators. Study design often requires large cohorts of par-ticipants. In many instances trials are carried out at various sites inseveral countries and local ethics committees and drug regulators arenot always aware of patient or investigator experiences at other in-ternational sites. Clinical trials are increasingly contracted to clinicalresearch organizations and patient recruitment agencies, which actas intermediaries between the sponsors of the study, the investiga-tors and the patients, and these escape appropriate monitoring.

Regulatory authorities have a responsibility for all clinical trials car-ried out in their country and they need to protect the safety, well-be-ing and rights of the subjects participating in trials by ensuring thattrials are adequately designed to meet scientifically sound objectives.They should also create legal structures and systems to support thedevelopment of norms and standards for clinical research, their im-plementation and oversight, and ensure that all trials are conductedaccording to the ethical and quality standards of good clinical prac-tices.

WHO is currently developing a manual that clearly articulates theroles and responsibilities of various stakeholders (e.g., sponsors, in-vestigators, regulatory authorities and ethics committees) involved inthe conduct of health and clinical research studies, including anystudy that may have an impact on the safety and well-being of hu-man subjects.

Role of regulators in improvingthe quality of ethical outcomes

Dr TAN Chor Hiang, Health Sciences Authority , SingaporeClinical research is rapidly evolving. During the 1990s, industry-spon-sored research moved rapidly beyond the familiar territory of theUnited States, the European Union, and Japan into large parts of Cen-tral and Eastern Europe, South America, Asia, and Africa (1). Clinicalresearch is now increasingly complex and there is a greater involve-ment of vulnerable populations in research. The United States Na-tional Institutes of Health Revitalization Act of 1993 includes guide-lines that require inclusion of women & minorities in clinical studies.


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Invariably and unfortunately, mishaps in research are also encoun-tered. Some commonly encountered and debated ethical issues inbiomedical research include use of control arms (placebo), data pro-tection, monitoring, role and responsibilities of institutional reviewboards, compensation for trial injury, patient confidentiality and pri-vacy, stem cell research, gene therapy, tissue banking and the in-formed consent process.

The ethical review committee or institutional review board (IRB)plays a critical role in ensuring human subject protection by havingeffective and functioning systems for initial review and approval oftrials, review of methods and materials to be used in obtaining anddocumenting informed consent, ongoing trial review and safetymonitoring. The most fundamental role of ethical review is to ensurethe application of basic ethical principles: respect for persons, benefi-cence and distributive justice, as articulated in such documents asthe Nuremberg Code and Declaration of Helsinki.

Compliance oversight findings have shown that there are weak-nesses in ethical review systems, particularly the lack of written pro-cedures for reviewing protocols and informed consent forms, failureto minute convened meetings, inadequate training of IRB members,insufficient resources, conflict of interest, lack of monitoring systems(Quis custodiet), composition and quorum requirements (2).

International focusOn 2 October 2001, the US Department of Health and Human Servicesreleased a report entitled The Globalization of Clinical Trials: A Grow-ing Challenge in Protecting Human Subjects (3). This report marks asignificant point in US policy toward the protection of human sub-jects in foreign clinical trials, and provides an impetus, along withclear direction, for a framework to ensure protection for clinical trialparticipants abroad. It recommends that regulatory bodies increasethe information they have on non-US IRBs and contribute to capacitybuilding. The US Department of Health and Human Services Officefor Human Research Protections encourages a system of accredita-tion for such IRBs.

An article entitled Ethical review and globalization of clinical trials (4)recognized that international guidance and national legislation areessential to developing well-functioning ethical review systems.However, international guidelines and national law alone will notsuffice. Without a systematic approach to information gathering andcapacity building, standards alone will not achieve greater protectionfor research.


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In the broadest sense, the human research protections programmeapproach is intended to address both accountability (compliance)and assurance — the accountability of all individuals involved in clini-cal research (not only the researchers), and the assurance of all enti-ties involved in clinical research (spanning administrative, legal, andregulatory compliance, biosafety, pharmacy, nursing, quality and riskmanagement, among others). A culture of compliance is regulation-driven; one of conscience is driven by professional responsibility tak-ing and sharing (5).

The situation in SingaporeIn October 2003, a draft bill to regulate research on human stem cellsand tissue was introduced in Singapore. The Regulation of BiomedicalResearch Act provides clear and stringent regulations for research us-ing human stem cells and tissues carried out in Singapore and willensure that all the work being done is ethically sound.

The Health Sciences Authority of Singapore is a one-stop regulatoryagency, administering a seamless regulatory process for all therapeu-tic products. Our vision is to be world class for scientific and regula-tory expertise in health sciences and our mission is to excel in apply-ing science to support healthcare services and regulation, serve theadministration of justice, and enhance safety in our community.

A formal regulatory framework for the governance of clinical researchis limited to clinical drug trials. It is a shared responsibility by the IRBand the Health Sciences Authority. The conduct of clinical drug trialsin Singapore is regulated by the Medicines Act 1975 and the Medi-cines (Clinical Trials) (Amendment) Regulations 1998, and the Singa-pore Guideline for Good Clinical Practice. The clinical drug trials regu-latory framework is being reviewed and some of the initiatives in therevised framework include improved agency oversight through GCPinspections, IRB verification, and trial centre licensing.

All other forms of biomedical sciences research in Singapore requireIRB approval at this point in time. Guidelines and position papershave been published to address ethical issues arising from biomedi-cal research, viz. the National Medical Ethics Committee’s guidelines,and position papers from the Bioethics Advisory Committee. A Bill toregulate research on human stem cells and tissue — The Regulationof Biomedical Research Act — is also currently being drafted.

The US Department of Health and Human Services commissioned areport following the death of 18-year-old Jesse Gelsinger during a


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1999 clinical study at the University of Pennsylvania. In October 2002,the Institute of Medicine produced a report on Responsible Research:A Systems Approach to Protecting Research Participants (6). One ofthe recommendations reads: “Broader federal oversight is needed toensure that the health and well-being of people who are enrolled inresearch studies, whether publicly or privately funded, are better-pro-tected. Congress should require every organization conducting re-search with human subjects to do so under the authority of a re-search participant protection programme, which would be subject tofederal oversight. However, ultimate responsibility for ensuring thatthe essential protections are in place and followed must rest with thehighest levels of the research organization’s leadership.“

In conclusion, this statement from the WHO Operational Guidelinesfor Ethics Committees that Review Biomedical Research (2000) (7)aptly summarises the shared responsibility for ethical outcomes inresearch: “Countries, institutions, and communities should strive todevelop ECs and ethical review systems that ensure the broadest pos-sible coverage of protection for potential research participants andcontribute to the highest attainable quality in the science and ethicsof biomedical research. States should promote, as appropriate, theestablishment of ECs at the national, institutional, and local levelsthat are independent, multi-disciplinary, multi-sectorial, and pluralis-tic in nature.“

References

1. Crawley, F.P. Good clinical practice in a global research setting: Achieving best practices in ethics & science,“Good Clinical Practice Journal, 6 (6) 5–35 (1999).

2. Office for Human Research Protections (OHRP), Division of Human Subject Protections, Compliance Over-sight Branch, OHRP Compliance Activities: Common Findings and Guidance – 7/10/2002 http://ohrp.osophs.dhhs.gov/references/findings.pdf

3.Department of Health and Human Services, The Globalization of Clinical Trials: A Growing Challenge in Pro-tecting Human Subjects. OIG, Washington, DC, September 2001 or www.hhs.gov/oig/oei/reports/ a542.pdf.

4.Crawley, F.P., Karbwang, J., Lin, Esber, E. Ethical review and the globalization of clinical trials. Applied ClinicalTrials, June 2002.

5. Whalen, M. D., Khin-Maung-Gyi, F.A. Human research protections and good clinical practice (GCP): the rela-tionship among GCP, the auditing process, and institutional review boards. Journal of GCP Compliance, 7: 44–48 (2003)

6. Institute of Medicine, Responsible Research: A systems approach to protecting research participants,October 2002. http://www.iom.edu/report.asp?id=4459

7. World Health Organization. Operational guidelines for ethics committees that review biomedical research,TDR/PRD/ETHICS/2000.1


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Regulatory aspects of genetransfer medicinal products

Klaus Cichutek, CPMP/EMEA Gene Therapy Expert GroupGene transfer medicinal products (GT-MP) are medicinal productswhich are either used with the aim of genetically modifying humansomatic cells in vivo and which consist of or contain ex vivo geneti-cally modified autologous, allogeneic or xenogeneic cells, or whichconsist of recombinant microbes used for other indications than theinfectious disease caused by the microbe used.

Genetic modification of cells, either ex vivo or in vivo, involves the useof replication-incompetent viral vectors, non-viral vectors or nakednucleic acid. In some cases, replication-competent microbes, such asreplicating adenovirus, are being used. Viral vectors commonly usedinclude retroviral, adenoviral, AAV and pox virus vectors — the safetyand efficacy profile of which are different. Therefore, each vector iscommonly used in specific settings. The modified cells used in vivo in-clude autologous or allogeneic cells, whereas xenogeneic cells or or-gans planned to be used in humans are considered xenogeneic celltherapy medicinal products. European definitions and technical re-quirements can be found in Part IV of the new Annex I of Directive2001/83/EC as amended by Directive 2003/63/EC and in the relevantEuropean Notes for guidance or Points to consider documents(www.emea.int.org).

To date, a marketing authorization of a GT-MP has been granted inChina, a number of scientific advice procedures with a view to mar-keting authorization in the European Union have been completedand some gene therapy products have obtained orphan drug status.Marketing authorization for industrially produced non-finished me-dicinal products may be obtained via the centralized procedure of theEuropean Medicines Agency, EMEA. Starting from May 2004, clinicaltrials in the EU using somatic cell and gene therapy medicinal prod-ucts will be approved by the national regulatory authority, and the lo-cal ethics committees will give a positive appraisal. Clinical trials, sofar mainly carried out in Europe and North America, have been phaseI/II trials with emphasis on analysing safety and obtaining first evi-dence for possible efficacy. Disease targets include monogeneic dis-eases, cancer, infectious, neurological and cardiovascular disease.With an increasing understanding of the underlying molecular biol-ogy, first evidence of possible efficacy has been obtained in a numberof clinical trials including those targeting ischaemia, head-and-neck


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cancer, haemophilia and monogeneic disease. With the improvementof gene transfer efficiency, serious adverse reactions are also beingobserved and will have to be addressed through improvement of vec-tors and strategies.

In general, clinical gene transfer medicinal products have presentedacceptable risk-benefit ratios. Clinically successful therapies havebeen noted for the treatment of monogeneic diseases such as SCID-X1 or ADA-SCID. First evidence of successful therapy has also been ob-tained in the treatment of graft-versus host disease following donorlymphocyte infusion during bone marrow transplantation or cardio-vascular disease. However, development of gene therapy productshas to be accompanied by the establishment of adequate regulationsincluding technical requirements. The EMEA Gene Therapy ExpertGroup is involved in harmonizing regulatory needs by reviewing im-portant clinical developments and highlighting the necessity of aregulatory framework.

The need for informed consent in clinical researchPatricia Saidón, Administración Nacional deMedicamentos, Alimentos y Tecnología Médica, ArgentinaInformed consent is the process by which a person voluntarily con-firms his or her willingness to participate in a particular research trialor study after having been informed of all aspects of the trial that arerelevant to the subject’s decision to participate. Informed consent isdocumented by means of a written, signed and personally dated in-formed consent form.

Informed consent is a process, and should be understood essentiallyas a documented procedure to ensure that (i) the subject controls thedecision on whether to participate in clinical research and (ii) thatsuch participation only occurs when the research is consistent withthe subject’s values, interest and preferences. Informed consent thusallows individuals to decide for themselves whether to participate inresearch. It is based in the principle of respect for persons and it pro-tects individual freedom of choice.

The most important goal of informed consent is that the patient hasan opportunity to be an informed participant in health care decisions.The following elements should be addressed or described in the in-formed consent process:


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1. An explanation of the study purpose and duration, includingan approximate number of subjects involved in the study.

2. A statement that the individual is free to refuse participa-tion and may withdraw from the trial at any time. Subjectsshould never be obliged to participate and investigators andtrial staff should not coerce or unduly influence a subject toparticipate or continue to participate in a trial.

3. A statement that the study involves research with a de-scription of procedures and their probable effect on thesubject. This includes (i) foreseeable harms, discomforts,inconvenience and risk, and (ii) benefits to subjects or thecommunity. Unverified efficacy or safety claims should not bemade. An explanation should be provided of all known alter-natives to the research project objectives, e.g. other treat-ments or interventions currently available.

4. Explanation of the extent of compensation and treatmentto be provided both within the trial and afterwards, includingdeclarations concerning the subject’s legal rights, responsi-bilities of the investigator, institution or sponsors in the eventof liability or negligence. A declaration of liability for trialcosts and information on conflict of interest of the investiga-tors.

5. Clearance from the ethical review committee or institu-tional review board that has reviewed the research trial.Identification of independent persons able to answer ques-tions about the research, rights of research subjects andresearch related injuries.

6. A statement that treatment or procedures may involvecurrently unforeseeable risk to the subject (or the embryo orfetus, if the subject is or may become pregnant). A statementthat any significant new findings developed during the trialwill be transmitted to the subject, especially if these mayrelate to the subject’s willingness to continue to participate.

7. Particular attention should be paid to the circumstancesinvolving subjects unable to consent or vulnerablepopulations (children, illiterate, physical incapacity, dementia,in emergency situations, populations with limited resources,individuals whose willingness to volunteer in a trial may be


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unduly influenced by expectations, persons kept in detention,armed forces, medical personnel, students, employees of thepharmaceutical industry, incurable patients, persons in nurs-ing homes and ethnic minorities). An independent witnessshould always be present in such a situation.

The consent processThe language used in informing subjects about the trial, includingthe informed consent form, should be at a level of complexity whichis understandable to the subject, the subject’s legal representative,or impartial witness.

The investigator should ensure that the subject has adequately un-derstood the information and should give each participant full oppor-tunity to ask questions. These should be answered honestly and com-pletely and, wherever there is doubt of comprehension, an oral orwritten test may determine whether the information has been ad-equately understood.

Before informed consent may be obtained, the investigator or a per-son designated by the investigator should provide the subject or thesubject’s legally acceptable representative ample time and opportu-nity to inquire about details of the trial and to decide whether or notto participate in the trial. Where appropriate and feasible, potentialtrial subjects should also have access to independent expertise to an-swer their questions. All questions about the trial should be an-swered to the satisfaction of the subject or the legally acceptable rep-resentative.

The principal or designated investigator is responsible for obtainingand documenting informed consent. The investigator should complywith applicable regulatory requirements and adhere to GCP and toethical principles that have their origin in the Declaration of Helsinkiand the CIOMS International Ethical Guidelines for Biomedical Re-search Involving Human Subjects. Prior to the beginning of the trial,the investigator must obtain approval of the trial and consent proc-ess from the ethical review committee or institutional review boardand any other legally required clearances. During the trial, anychange in the informed consent process should be subject to ethicalapproval in advance of use. In many countries, the regulatory author-ity should also approve the Informed consent procedure.

Prior to participation, the informed consent form should be signedand dated by the subject (or under special circumstances by the sub-


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ject‘s legal representative) by the person who conducted the in-formed consent discussion, and by an independent witness. A copy ofthe signed consent should be given to the subject.

Challenges to regulators: safety monitoringBy the time a medicinal product is marketed, it has been tested in tri-als involving only 2000 to 3000 subjects. The results of these trialswill subsequently be used as evidence to determine safety prior tomarketing in large populations. It is accepted that any medicine car-ries some risk, so that it is important to monitor the effects, both in-tended and unwanted, to gain reliable evidence upon which to base arisk/benefit assessment. As with all new medicines, the early identifi-cation of unexpected adverse reactions and their risk factors is essen-tial for the rational use of medicines and to maintain public confi-dence in their use. This is the role of pharmacovigilance, a process ofinformation gathering on adverse reactions which may assist in iden-tifying the most appropriate medicine for each patient.

Pharmacoeconomic studies suggest that governments pay unneces-sary amounts from health budgets to counter the costs caused by ad-verse reactions. In the USA, adverse drug reactions are the fifth lead-ing cause of death. Other countries spend up to 17% of theirhealthcare budget dealing with ADRs. Meanwhile, a pharmacovigi-lance system would not cost more than 1 dollar for every 850 – 1000dollars of medicines purchased.

Furthermore, current post-marketing surveillance systems may notbe adequate for ensuring the safety of medicinal products, particu-larly in developing countries. Present systems rely heavily on sponta-neous reporting, yet under-reporting and inadequate provision ofdata are common and drug safety monitoring is established in only70 countries. Often, ADRs may be country-specific – since medicalpractice, ethnic and racial factors may affect the response to drugs.The WHO Programme on International Drug Monitoring maintains aglobal database of more than 3 million reports of adverse reactions todrugs. However, other tools need to be developed and linked to thecurrent system to promote better transmission of data and morecomplete reporting.

No medicines regulatory authority, however competent and sophisti-cated it may be, can fully anticipate and meet the need to address thesafety and rational use of new medicines prior to their introduction


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for general use. Regulatory authorities have come to depend increas-ingly on their national pharmacovigilance centres for the ongoing re-view of the safety of medicines that they approve and particularlythose medicines used in the public sector.

Success factors in nationalpharmacovigilance programmes

Abida Haq, National Pharmaceutical Control Bureau, Min-istry of Health, MalaysiaThe word pharmacovigilance often conjures up the idea of spontane-ous adverse drug reaction (ADR) reporting. But pharmacovigilanceextends beyond this activity — it is also about the re-evaluation ofmarketed drugs, risk management, communicating drug informa-tion, promoting rational drug use and crisis preparedness. The suc-cess of a national pharmacovigilance programme will depend onmany of the following suggestions:

• Programme managers should tailor the pharmacovigilancesystem according to the capacity and capability of existingresources within the national context.

• Developing nations should utilize work already carried out byother centres, adapt and adopt systems practised elsewhere,and identify and focus on issues which are of importance andrelevant.

• Creating awareness and training within the system is impor-tant. Health professionals should be trained in pharmacovigi-lance and this should be incorporated into continuing medicaleducation programmes.

• The pharmaceutical industry should also play an active role inmonitoring, including of newly marketed drugs. Mechanismsshould also be developed to include information from con-sumers on adverse reactions encountered with the use ofover-the counter and traditional medicines.

• Guidelines should be made available for health professionalsand the industry on how and to whom to report ADRs.


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• Information sharing through effective networking betweenregulatory agencies and the WHO is imperative and informa-tion should be utilized optimally to help identify signals andmake judgments based on good science.

• An objective of pharmacovigilance is to ensure rationalutilization of drugs. Dissemination of information tostakeholders and prescribers should be effective and efficientto avoid delay and ensure that risks to consumers are mini-mized.

• The decision making process should be credible, transparentand free of external pressure. As far as possible, decisionsshould be made based on input from the relevantstakeholders taking into account the effect of these decisionson the health system.

• Crisis preparedness and crisis management should beplanned.

Until now, pharmacovigilance has concentrated on the safety of indi-vidual drugs. However, to be successful it should also be patient-ori-ented, and seen as a clinical and public health issue and not just aregulatory function.

How pharmacoepidemiologycan improve pharmacovigilance practice

Francisco J. de Abajo, Division of Pharmacoepidemiologyand Pharmacovigilance, Spanish Agency for Medicinesand Healthcare Products, Madrid, SpainPharmacovigilance is a public health practice aimed at analysing andmanaging the risks of medicinal products once they have been mar-keted. According to this definition, pharmacovigilance can be dividedin two distinct phases (i) risk analysis and (ii) risk management. Riskanalysis concerns identification, quantification (or estimation) andevaluation of emerging risks in a stepwise manner, while risk man-agement concerns the implementation and follow-up of adoptedregulatory measures, communication of risks to health professionalsand/or the population at large, and the setting up of specific preven-


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tive strategies (1, 2). Risk analysis is data-driven whereas risk manage-ment is action-driven, and the decisions taken constitute the bridgebetween these two areas.

In the realm of pharmacovigilance, the identification of risks is nor-mally achieved by spontaneous reporting schemes, the bedrock ofany drug surveillance strategy. However, according to the above men-tioned scheme the identification of a risk should be followed by itsproper quantification, which means (i) the measurement of thestrength of the association between the drug and the suspected ADR(as a way to confirm or refute the causal relationship); (ii) the estima-tion of the impact of such a risk in the exposed population; and (iii)the identification of effect modification factors (risk factors). Al-though spontaneous reports compared with consumption or salesdata may provide a first estimation of the risk (e.g. reporting rates),the limitations of such a simple approach are well-known (e.g. vari-able under-reporting, selective reporting, lack of adjustment for con-founding factors, difficulty in assuming a daily dose etc.), in particularfor comparison between different drugs. An appropriate quantifica-tion will normally require the implementation of appropriate epide-miological studies.

Experience shows, however, that too often regulatory authoritiespass directly from risk identification to risk evaluation and take im-portant decisions solely on the grounds of spontaneous reports. Al-though this may sometimes be warranted, for instance when thecausal relationship can be easily established by individual case re-ports e.g. anaphylactic shock, or the suspected ADR is reasonablylinked to the drug and represents a very serious issue prompting ap-plication of the precautionary principle, it is not frequently the case. Agood number of pharmacovigilance signals cannot be properly as-sessed without the help of pharmacoepidemiologic studies: Dohighly active antiretroviral drugs increase the risk of myocardial inf-arction (3)? Does the use of SSRIs increase the risk of serious bleedingdisorders (upper gastrointestinal or intracranial haemorrhages) (4, 5)?Is the use of dinoprostone (PGE2) as a labour inducer associated withthe increased risk of postpartum disseminated intravascular coagula-tion (6)? Spontaneous reports have raised a signal in all these exam-ples, but a rational decision was not possible because of the presenceof major uncertainties.

A prevailing fact that regulatory authorities have to face is that thepractice of pharmacovigilance is not optimal because risk quantifica-tion is rarely achieved through appropriate epidemiological studies.The reason for this shortcoming is probably twofold: the prevailing


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conception that pharmacovigilance is just monitoring individual casereports; and the lack of efficient data sources to perform the studiesin the timeframe required by a risk analysis process in pharmacovigi-lance, where units are normally months, not years.

Regulatory authorities are not comfortable with this status quo andmay need to progress in two directions in order to improve pharma-covigilance practice by providing or reinforcing training in epidemio-logical methods among pharmacovigilance teams, and supportingthe development of permanent and efficient data sources in respec-tive countries that may allow performance of epidemiological studiesto assess signals raised by spontaneous reports or any other source.Efficient data sources could be automated healthcare databases (ei-ther requiring record-linkage or stand-alone databases), but may alsobe permanent registries for specific diseases potentially associatedwith drugs (ideally with a case-control scheme), or product-specific orpatient-specific large and long-term cohorts. Although someprogress has been made in the past, a greater and generalized im-pulse is needed for the proliferation of these efficient data sources.Multi-site database studies would be necessary in the future to facerisks emerging in the early postmarketing phase, where even thelargest databases are underpowered. Health authorities have muchto say in this development.

In line with this idea, the Spanish Agency for Medicines and HealthProducts has set out a programme of funding aimed at supportingsome private initiatives such as case-control surveillance of blooddyscrasias in the Barcelona area, a register of serious liver injuriesprovided by a nationwide network of 37 hepatology units coordinatedby the University of Malaga, or the long-term follow-up ofrheumatologic patients treated with anti-TNF products managed bythe Spanish Society for Rheumatology. In addition, the SpanishAgency has assumed the challenge of setting up a database (calledBIFAP) using clinical records from general practitioners (7). Up to now,this database includes information from around half a million pa-tients provided by more than 400 general practitioners, and it is cur-rently in the clinical validation phase. One of the important advan-tages of this database is that health data are anonymous, guarantee-ing the confidentiality of patient identity.

Sometimes, the study we need is not an etiology-oriented one butmerely a drug utilization enquiry. In a good number of pharmacovigi-lance crises, the misuse component plays a fundamental role (for in-stance, the cerivastatin case with the highly prevalent concomitantuse of gemfibrozil and the habit of using high doses from the very be-


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ginning of treatment). Early detection of such misuse problems (oroff-label use) may help to prevent risk situations. Yet, efficient andvalid data sources that complement spontaneous reporting are nec-essary as well. To this aim, this year, the Spanish Agency is planningthe establishment of a network of community pharmacies to provideour agency with information about drug utilization.

Pharmacovigilance is a cooperative and worldwide effort. Although itis clear that developed countries have a greater responsibility in set-ting up the newer data sources, we need better pharmacovigilancepractices. The developing countries should also be prepared forprogress by acquiring at least the necessary training in order to keepup with the pace of modern pharmacovigilance.

References

1. De Abajo, F., Montero, D., Cach, A. Pharmacovigilance: goals and strategies. Methods and Findings in Experi-mental Clinical Pharmacology, 22: 405–407 ( 2000).

2. The Uppsala Monitoring Centre. Expecting the worst in anticipating, preventing and managing medicinalproduct crisis. WHO Collaborating Centre for International Drug Monitoring, 2003.

3. The Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group. Combination antiretroviraltherapy and the risk of myocardial infarction. New England Journal of Medicine, 349: 1993–2003 (2003).

4. De Abajo, F., Montero, D., GarcÌa RodrÌguez, L.A. Association between selective serotonin reuptake inhibitorsand upper gastrointestinal bleeding: population based case-control study. British Medical Journal, 319: 1106–1109 (1999).

5. De Abajo, F., Jick, H., Derby, L., et al. Intracranial haemorrhage and use of selective serotonin reuptake inhibi-tors. British Journal of Clinical Pharmacology, 50: 43–47 (2000).

6. De Abajo, F., Meseguer, C., Antinolo, G. et al. Postpartum disseminated intravascular coagulation anddinoprostone: a hospital based retrospective case-control study. Pharmacoepidemiology and Drug Safety, 12:S199-S200 ( 2003).

7. Salvador, A., Moreno, J.C., Sonego, D. et al. El proyecto BIFAP: Base de datos para la InvestigacionFarmacoepidemiologica en Atencion Primaria. Atencion Primaria, 30: 655–661 (2002). (English version avail-able in www.bifap.org).

Assuring the safety and quality controlof traditional medicines

Dr LIN Ruichao, National Institute for the Control of Phar-maceutical & Biological Products, State Food & Drug Ad-ministration, People’s Republic of ChinaWith its centuries-old history in research, production and application,China is the home of traditional Chinese medicine (TCM). Guarantee-ing the safety of TCM requires the establishment and perfection ofquality assurance and control systems based on scientific methods.The State Food & Drug Administration (SFDA) implements quality


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control and management of all TCM in accordance with the require-ments of the Chinese Law on Drug Management.

Fundamental principles of Good Agricultural Practice for ChineseCrude Drugs (GAP), Good Laboratory Practice (GLP), Good ClinicalPractice (GCP) and Good Manufacturing Practice (GMP) are the pre-vailing references in the safety evaluation of medicines worldwide.Guaranteeing the safety and efficacy of medicines to its people is asacred responsibility of SFDA.

Quality assurance provides a technical guarantee of the safety, effi-cacy and quality control of a drug. Ten years ago, SFDA issued a Revi-sion and Supplement to the New Drug Examination and ApprovalMeasures Related to TCM in accordance with the Law on Drug Man-agement, requiring rigorous monitoring of contamination caused byexternally harmful substances. China began specialized research ofheavy metal and pesticide residue in crude drugs in the late 1980sand has established quality criteria for TCM. Toxic ingredients have al-ways been defined as a key focus for quality control, with content rig-idly controlled within defined limits.

The principles of safety, efficacy and quality are also applicable toTCM. However, processing of TCM is complex and differs from medici-nal drugs. A major feature of quality control is the need for proce-dures which are specific to TCM preparations and which can be han-dled within clearly defined quality criteria for Chinese crude drugs. Atpresent, quality control of TCM has surpassed conventional identifica-tion methods and experience so that development of TCM safety re-quirements must adhere to scientific criteria. Quality control andmanagement of TCM is a significant task, with many hurdles to over-come. Through common efforts, good quality, safe TCM products willcontinue to benefit patients.

Regulation of herbal medicines in Nigeria

Dr Dora Akunyili, National Agency for Food and DrugAdministration, NigeriaDue to increased interest in the use of herbal medicines in Nigeriaand the need for regulation of herbal medicines, the Government hasestablished various committees and boards and approved a NationalPolicy on Traditional Medicine.

Until 2001, there was little or no regulation of herbal medicine by theNational Agency for Food and Drug Administration (NAFDAC). This led


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to herbal practitioners producing, packaging, advertising and sellingherbal products without any control. However, in 2001, NAFDACrequested all herbal medicine practitioners to have their productsscreened prior to registration. The herbal medicine practitioners werealso invited to a workshop to participate in drafting guidelines for theregistration of herbal products. This action has led to increased publicconfidence in the use of herbal medicines. NAFDAC acknowledgesWHO‘s contribution to progress, and is now seeking support from theInternational community for staff training, establishment of a herbalcontrol laboratory and collaborative studies.

Safety surveillance system for natural healthproducts

Dr Duc Vu, Director, Marketed Natural Health ProductsDivision, Health Canada

As with all health products, the benefit/risk ratio of natural healthproducts (NHP) licensed for sale in Canada should be favourable. InCanada, the effective safety surveillance of health products relies ontwo components: A pre-market assessment system that requiresevidence to support the quality, safety and efficacy of products; and apost-market surveillance system that efficiently and effectivelycollects data, makes it easy to access reported information andincludes an effective risk communication strategy.

In January 2004, the Natural Health Products Directorate withinHealth Canada has implemented Natural Health Product Regulations.Requirements under the new Regulations include product licensing,good manufacturing practices in licensed facilities, standards ofevidence to support the health claims made on the product label, andmandatory reporting of adverse reactions by market authorizationholders. In addition, the post-market surveillance Directorate of theMarketed Health Products Directorate coordinates post-marketmonitoring activities, and collects and assesses safety informationrelated to licensed NHPs. The post-market Directorate also developscommunication strategies to increase awareness of potential safetyissues and stimulate adverse reaction reporting from health careproviders, and enhance safe and rational use of NHPs.


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Consumer/patient information on safe use ofherbals

Dr Rolf Spang, Swiss Agency for Therapeutic Products,Swissmedic, SwitzerlandDevelopment of patient information (PI) began in Switzerland in 1983with a 5-year experimental phase, leading to mandatory use for allproducts on the market as of 1 January 1989. In 1994, PIreqquirements were extended to cover all products (in line withintroduction of a PI by the European Union). PI complements productinformation, and both are published in the Swiss Kompendium. The PI,in the three Swiss languages, must contain all relevant patientinformation in a simple, intelligable language without use ofscientific expressions with a view to ensuring the correct and safe useof medicines without compromising compliance.

Since introduction of the PI in Switzerland, some minor modificationshave been made. Different types of PI are used for syntheticpharmaceutical substances, herbals and homoeopathics. For herbals,the words “herbal medicine” has to be attached to the brand name.Therapeutic properties are differentiated depending on presence orlack of clinically tested efficacy, so that different PI formulationsinclude “traditionally attributed properties such as …” or “acts against…”. Contraindications and precautions are merged to improve clarityof information.

Keeping a balance between information and advertising is not aneasy task. The PI is enclosed as a printed leaflet in all productpackages. It is also available on the internet and company website.Advertising to the public is allowed for herbals and there is no pre-vetting of the advertisements, except for advertising on television,radio or cinema, and for a few product groups.

Herbals are rarely perceived as medicinal products by the generalpublic, but are considered natural and safe. However, many reportsshow that this may not be the case and there may be importantquality and safety issues involving toxicity and adverse drugreactions.

In conclusion, it is important to make the public and health careprofessionals aware that herbals are also medicines and to watch foradverse drug reactions.


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Recommendations

Recommendations from the Eleventh ICDRA aim to provide themeans for future collaboration among Member States, drug regula-tory authorities, WHO, interested agencies and institutions, and willset priorities for WHO action and support.

Progress report on Tenth ICDRAParticipants recognized the progress made in many areas of medi-cines regulation since the Tenth ICDRA in Hong Kong in 2002. As glo-balization continues and has a profound impact on the developmentand marketing of medicines, strong international collaboration be-tween regulatory authorities is needed to safeguard public health in-terests.

In view of continued regulatory problems and new challenges, par-ticipants stressed the importance of government commitment tostrengthening national regulatory systems and policies and the needto intensify international collaboration to improve access to safe andeffective medicines of good quality.

Regulatory aspects of access to medicinesThe mission of regulatory authorities is to promote and protect pub-lic health. The lack of access to medicines remains a huge concern,whether these are essential medicines, vaccines, orphan drugs ordrugs for tropical diseases. To facilitate access, regulators and allother stakeholders need to be actively involved in identifying difficul-ties and seeking solutions leading to balanced approaches to accesswhich do not compromise public health safeguards.

Recommendations• Regulators have a role and responsibility to facilitate access

to drugs of public health importance including proposingchanges to the respective regulations in order to facilitateaccess without compromising quality, safety and efficacy.


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• When considering marketing authorization (registration)applications, regulators should give priority to medicines ofhigh public health importance in their countries. Regulatorsshould consider mechanisms to facilitate registration, such asreducing fees or other related costs.

• As part of the medicines approval process, regulators shouldcarry out an appropriate risk benefit assessment to allow foradjustment to the needs and profile of the anticipated pa-tient populations.

Strengthening of regulatory frameworksfor medicinal productsThe establishment of a well-functioning national regulatory systemas an integral component of effective public health leads to betterpatient protection through provision of medicines which are safe, ef-ficacious and of good quality. Cooperation, communication and trustbetween national regulatory authorities based on common principlesand harmonized approaches will strengthen the effectiveness of na-tional regulation and international collaboration. Transparency is animportant aspect of regulatory systems and helps to build public con-fidence, while facilitating cooperation and information exchangeamong regulators.

• Member States should strengthen their efforts to increasetransparency of the work of national regulatory authorities.Regulatory guidelines, procedures and criteria as well as dataabout registered medicines should be made publicly availableto all stakeholders.

• National regulatory authorities should make available to thepublic, in understandable language, negative and positiveassessment reports (including pharmacovigilance reports).

• National regulatory authorities should provide applicants fora marketing authorization with full information on regulatorydecisions and an explanation of the reason for such decisions.

Pharmacovigilance practicesSpontaneous reporting is the mechanism used for compiling adversedrug reaction reports and regulatory authorities take important deci-sions based on these data. Pharmacovigilance is a broad concept, and


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also includes the re-evaluation of marketed drugs, risk management,communicating drug information, promoting rational drug use andcrisis preparedness. It is becoming increasingly important to providetraining in all of these activity areas and to carry out intensive moni-toring of new drugs in order to evaluate the risk/benefit. Increasingly,medicines are being donated for off-label indications for specific pub-lic health needs and it is important that sufficient data is available tothe national regulatory authority on safety, efficacy and quality.

Recommendations• Member States should be encouraged to involve pharma-

covigilance staff in public health risk assessment, manage-ment and communication for medicines safety activitiesincluding adverse reactions monitoring, medicines re-evalua-tion, drug information, rational drug use, lack of efficacy andcrisis preparedness.

• Increasingly, certain medicines are approved based on specialconditions, such as finalization and reporting of Phase IVstudies. National regulatory authorities should collaborate onharmonizing the terms of conditional approval, and developsystems to allow sharing of information on medicines in thiscategory.

• All sponsors and donors of medicines should provide suffi-cient data to allow the national drug regulatory authority tobe assured that the product being donated, or recommendedfor use, meets appropriate standards of safety, quality andefficacy. Obligations to conduct post-marketing surveillanceas a public health protection measure should also lie withsponsors and donors, as appropriate. International agenciesand aid programmes should make every effort to comply withthese requirements and provide the necessary data.

• Member States should be encouraged to establish databasesof clinical information suitable for epidemiological studies toexamine and quantify signals of possible emerging risk.

• WHO should coordinate and develop training resources inpharmacovigilance and pharmaco-epidemiology and expandits commitment to include training programmes in each of itsregions.

• WHO should provide, upon request, technical advice andsupport to Member States on the appropriateness of post-


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marketing surveillance plans submitted by sponsors when amedicine is being introduced to manage a specific publichealth campaign in that country.

• WHO should investigate the feasibility and potential utility ofcreating a database of “recommendations for action” arisingfrom evaluations made by national regulatory authorities ofthe periodic safety update reports (PSURs) in order to improvethe usefulness of such information by making this generallyavailable.

Pharmacopoeias in a changingregulatory environmentPharmacopoeial standard-setting for starting materials and finisheddosage forms underpins the work of drug regulatory authorities byproviding the means of ensuring the quality of medicines, particularlymultisource (generic) products.

Increased collaboration and coordination at international level ofpharmacopoeial bodies and all related parties is needed: (i) for the de-velopment and analysis of quality control specifications; (ii) to speedup development of pharmacopoeial specifications; (iii) to address theincreasing diversity and complexity of impurity profiles and limits setat international level, especially for pharmaceutical starting materi-als; and (iv) to promote independent and worldwide validation of ana-lytical methods to ensure the quality of traded and sourced productsinternationally.

The promotion of good quality pharmaceutical products, and the de-velopment of quality control methods — in particular to detect coun-terfeit drugs — is important for public health. Participants agreed onthe need for international harmonization of quality control specifica-tions, and recognized WHO‘s leadership role in providing normativeguidance for quality control and quality assurance of medicines, par-ticularly in the development and international harmonization of phar-macopoeial specifications for new drug entities, including antiretrovi-rals, anti-tuberculosis and antimalarial medicines.

Recommendations• Member States should encourage close collaboration between

regulatory authorities and pharmacopoeial secretariats/commissions.


38

• In collaboration with those concerned, WHO should organizean international conference on pharmacopoeial issues toexchange views and experiences among pharmacopoeialbodies and regulators.

• In collaboration with parties concerned, WHO should developa harmonized approach to providing internationally validatedspecifications for medicines for neglected and emergingdiseases with high public health risk.

• WHO should continue to support the establishment of inter-national chemical reference substances (ICRS) and assist intheir supply, particularly for medicines used in the treatmentof diseases with high public health impact.

Regulatory assessment of combination productsCombination products for various diseases have always been used inmedical practice. Today, HIV/AIDS, tuberculosis and malaria are themajor infectious diseases threatening public health and the focus ofmany national, regional and global initiatives. Combination therapy isconsidered essential for their treatment as well as for the preventionof drug resistance. Attempts to manage these diseases include thedevelopment of fixed dose combinations (FDC) of individual drugs tobe administered together in one finished dosage form. Well docu-mented clinical evidence of the efficacy and safety of the loose com-bination is a key entry point for development of any FDC drug. Cur-rently, there are no uniform principles, guidelines or internationalstandards addressing the development and regulatory assessment ofFDCs. Only a few countries have specific FDC regulatory guidelinesavailable and irrational combinations are still common in several mar-kets.

Recommendations• In countries where specific guidelines do not exist, regulators

need to establish clear quality, safety and efficacy require-ments for registering fixed dose combination medicines,particularly prescription-only drugs. Regulators should criti-cally review the existing fixed dose combination drugs on themarket and withdraw those which do not meet these require-ments.

• WHO is urged to create , as a matter of urgency, model guide-lines for regulatory approval of prescription-only fixed dosecombination drugs with special emphasis on drugs for com-municable diseases with high public health impact.


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Regulators, good clinical practice and ethicsApplication of good clinical practice (GCP) guidelines assures thatclinical studies on medicinal products meet scientific and ethical re-quirements. However, recent advances in medicine may encompassareas of clinical research not covered by existing GCP guidelines andthis gap should be filled since all clinical research, including researchon gene therapy and biotechnology products, should be conductedunder rigorously implemented GCP. Since data on the safety and effi-cacy of innovative products may be limited, it is important that na-tional regulatory authorities strengthen mechanisms to share knowl-edge and experience. Given the increasing tendency to involve vulner-able subjects in research, there is a special need to strengthen the ap-plication of ethical principles in research carried out in thesepopulations.

Recommendations• Member States should implement good clinical practice (GCP)

guidelines to assure that clinical studies follow scientific andethical requirements. All clinical research, not only for medici-nal products, needs to be regulated.

• Member States should ensure that informed consent proc-esses, particularly for vulnerable populations and for obtain-ing biological samples for genetic studies, meet all GCP, na-tional and ethical requirements.

• Member States should recognize that gene therapy is a newcomplex area of medicine needing rigorously implementedGCP and ethical oversight.

• WHO is requested to gather existing knowledge and experi-ence of safety, efficacy and quality of innovative biotechnol-ogy products and share this information with Member States.

• WHO is requested to accelerate its work in regulatory capacitybuilding for assessment of vaccines and medicines of publichealth importance and to explore options for providing exter-nal regulatory expert support for assessment of clinical trialapplications in countries with limited resources.

Public health needs vs. the marketplaceDevelopment of new drugs is often driven by market forces. Somemedicines for priority disease of public health impact are commer-cially unattractive, and this is often because they are unaffordable bypoor populations. Effective mechanisms compensating for this mar-


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ket failure are needed to bridge the gap. Regulators, together withother stakeholders, can play an important role in supporting initia-tives aimed at creating new drugs for diseases where there is no mar-ket attractiveness by motivating investment into research and devel-opment. However, there is also a regulatory capacity gap to over-come, as regulators from developing countries have limited capacityto advise on drug development or assess the safety, efficacy and qual-ity of new drugs created for diseases exclusively prevalent in thosesettings.

Recommendations• WHO is encouraged to continue cooperation with Member

States, industry and other stakeholders in order to promoteand facilitate development of new treatments for diseasesthat have little market potential, in particular for diseasesprevalent in developing countries (neglected diseases).Mechanisms and incentives should be created for moreproactive involvement of national regulatory authorities in allstages of research and development of these products.

• WHO should continue facilitating regulatory capacity build-ing and networking among regulators of different countriesin order to empower regulators in countries with limitedresources to take informed and evidence-based decisions.

• WHO should explore the potential of creating distancelearning courses for regulators.

Safety of herbal medicinesThe use of herbal medicines is increasing rapidly worldwide. Al-though the reasons for this may vary in different settings, the safetyof herbal medicines is a common global concern. Both public and na-tional health authorities are committed to making progress in ensur-ing the safe use of herbal medicines. This is a very complicated andcomplex issue because of differing regulatory requirements, avail-ability and suitability of technical methods for quality control, post-marketing quality surveillance, and safety monitoring, the presenceor absence of qualified practitioners and consumer education. Majorissues concerning the safe use of herbal medicines are set out below.

Recommendations• The safe use of herbal medicines requires adequate regula-

tion. Member States should continue to adapt their national


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and/or regional regulatory framework, including pharma-covigilance, to the specific requirements of herbal medicines.WHO should continue to provide support including guidanceand training programmes.

• Quality assurance and quality control of herbal medicinespresents specific challenges. WHO should continue to providetechnical guidelines, particularly for the quality control ofcombination products and criteria for reference substancesand materials.

• Awareness amongst consumers on the benefits and limita-tions of herbal medicines needs to be strengthened. MemberStates should consider preparing a policy on consumer infor-mation and guidelines on the advertising of herbal medicines.WHO should provide general guidance to support theseactivities.

• Providers of traditional/complementary health care play animportant role in the safe use of herbal medicines. MemberStates should explore appropriate mechanisms to ensureadequate training and education of these health care provid-ers. WHO should provide policy and technical guidance.

• Regulatory agencies should work together to make the bestuse of scientific resources related to herbal medicines. Sharingnational experience and information is crucial. WHO shouldfacilitate these activities e.g. by providing updated mono-graphs on medicinal plants and technical/regulatory guid-ance.

Assuring quality and safety of blood productsBlood and blood products are essential for the treatment of a numberof life-threatening conditions. However, because blood may transmitinfectious agents this can also cause severe harm to the recipients.During the Ninth and Tenth ICDRAs, emphasis was therefore given toprocedures aimed at inactivating and removing infectious agents. Inorder to avoid transmission of infectious agents in a reliable manner,good manufacturing practice (GMP) has to be implemented as an es-sential tool of quality assurance. In addition, adherence to GMP at alllevels of the process, from donor to recipient, is a prerequisite for con-sistent quality in the preparation of blood and blood products.


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Recommendations• WHO’s policy to give high priority to the implementation of

GMP in blood and plasma collection establishments is wel-comed. Educational programmes and training opportunitiesshould be continued and strengthened. Guidance documentsshould be developed and/or updated.

• In order to facilitate the enforcement of GMP in both blood/plasma collection and fractionation facilities, WHO shouldpromote joint inspections between several countries underthe guidance of experienced inspectors.

• WHO should promote cooperation between regulatoryauthorities with regard to GMP compliance aimed at mutualagreements among Member States.

• WHO should contribute to advancing the technical expertiseof regulatory authorities by enabling the creation of regionalnetworks to facilitate their regulatory role in the area ofblood and blood products.

• WHO should facilitate the formation of a global network ofregulatory authorities for blood and blood products.

Human tissue: problems and challengesfor regulatorsThe transplantation of human cells, tissues and organs has becomethe treatment of choice for a wide range of both fatal and non-fataldiseases. The volume and complexity of activities relating to trans-plantation is growing rapidly. The ethical and safety risks of trans-plantation require effective regulatory oversight at national level,and international cooperation.

Given the rapid global increase in the allogenic transplantation ofcells, tissues and organs, and the associated ethical and safety risksthis entails, Member States should develop and implement effectivenational regulation of procurement, processing and transplantationof human cells, tissues and organs.

Recommendations• To facilitate this process, WHO is requested to develop clear

guidelines for the quality, safety and efficacy of human cell,tissue and organ transplantation.


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• To complement the regulation of human cell, tissue andorgan transplantation, Member States should develop andimplement effective surveillance after cell, tissue and organtransplantation.

• WHO should facilitate these surveillance activities by devel-opment of appropriate written standards and referencematerials

Regulatory tools for providing drug informationAccurate drug information is essential for the rational use of medi-cines. Assessment of safety, efficacy and quality of products includesalso assessment of product information provided by the applicant ofthe marketing authorization. Although national regulatory authori-ties have the responsibility of validating the correctness and appro-priateness of the product information, resource constraints may limitthe capacity of small regulatory authorities to be able to verify thequality of information provided by the manufacturers.

Recommendations• National regulatory authorities should establish and imple-

ment requirements for product information in line with theinformation provided in the summary of product characteris-tics (SPC) as part of their national drug registration process.

• At national level, product information should be harmonizedfor all products having the same active ingredient.

• WHO should develop guidance and new tools to controlpromotion and drug information.

• National regulatory authority-approved information shouldbe the reference for providing independent information andthe benchmark for controlling promotion. Approved informa-tion should be made available on the regulatory agencywebsite.

Harmonization updatesHarmonization of technical requirements for the registration ofmedicines can contribute to public health by improving access to safe,effective and good quality medicines. It can also facilitate develop-ment of a fair and transparent regulatory process, improve interna-tional collaboration, reduce duplication of work by different regula-


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tory agencies and facilitate trade and competition. Harmonizationinitiatives are ongoing in all WHO regions. The major focus of many ofthose initiatives is to first harmonize basic regulatory requirementsfor generic drugs. In contrast, the International Conference of Harmo-nization (ICH), an initiative set up between the European Union, Ja-pan and USA, has been focusing on requirements to evaluate thequality, safety and efficacy of new innovative drugs, thus avoiding thenecessity to duplicate many time-consuming and expensive test pro-cedures. ICH has established a Global Cooperation Group for non-ICHharmonization initiatives to learn from ICH experience.

Recommendations

• WHO should continue to support regional and sub-regionalharmonization initiatives that contribute to public healthpriorities. WHO should facilitate information exchange be-tween different harmonization initiatives and report onprogress made in these initiatives through its website.

• Regional harmonization initiatives should have clear publichealth priorities according to local needs, clear milestones tomeasure progress, and appropriate resources to makeprogress possible. Member states are encouraged to facilitateharmonization which will increase availability and accessibil-ity of medicines.

• The ICH Global Cooperation Group should continue to serveas a forum of discussion and dialogue between ICH and non-ICH harmonization initiatives recognizing different regionalneeds, priorities and capacity.

Promoting good regulatory practicesTo meet the objectives of promoting and protecting public health, na-tional regulatory authorities need to carry out their functions effec-tively and efficiently within a set of principles based on transparencyand good governance. The issues that are necessary to promote goodregulatory practices nationally and internationally includesustainability of resources, optimal structure, effective cooperationwithin the agency and with other agencies, transparency and ac-countability, competence in evaluating efficacy, safety, and quality,timeliness, independence, collaboration as a service provider, sharinginformation, harmonization, and mutual recognition. In many cases,regulatory authorities do not have sufficient resources to carry outthese activities. Most importantly, regulatory agencies must be ac-


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countable and decision-making processes must be transparent butthis needs to be balanced against the need for protecting the confi-dentiality of the data that has been submitted by the manufacturer.Sources of information and the decision process should be made pub-licly available whenever possible.

Good regulatory practices thus cover an evolutionary process, withgood practices built into the systems which continuously reinforcecollaboration and trust. Regulatory authorities should establishmechanisms to ensure the quality of the procedures they operate to.

Recommendations• WHO should develop the tools and guidelines needed to help

national regulatory authorities effectively implement theprinciples of good regulatory practices.

• Member States should encourage interagency cooperationfor effective implementation of drug regulation involvingnational regulatory authorities, customs, judiciary, police, civilsociety and other relevant bodies set up to protect publichealth.

• National regulatory authorities should formulate a clearmission statement to reinforce effective and efficient drugregulation and customer satisfaction and make use of bench-marking to improve their performance.

• National regulatory authorities should nurture good regula-tory governance (integrity, transparency, accountability, publicservice ethics) to establish credibility and gain confidence. Thepolitical governance responsible for national regulatoryauthorities should promote teamwork, overcome bureaucracyand streamline work.

• WHO should promote and provide technical assistance forthe evaluation of regulatory capacity of national regulatoryauthorities in order to analyse the situation and to undertakenecessary corrective measures.

Regulatory aspects of supply of quality medicinesAccess to quality medicines contributes to improving human healthand promoting well-being. Rigorous implementation of good manu-facturing practices in the production of medicines will ensure thatonly safe, quality products are allowed on the market.


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The importance of quality has been repeatedly underlined by the oc-currence in various countries of counterfeit and substandard drugs.Evidence shows an increase in production, distribution and saleworldwide of counterfeit, spurious and substandard medicines whichdo not comply with any quality standards. Such products are a wasteof money for the people who buy them, prolong treatment periods,exacerbate the conditions being treated, increase the emergence ofdrug resistance and can even cause death.

Special efforts have been undertaken to raise awareness of the im-portance of regulatory measures covering trade in products andstarting materials, including active pharmaceutical ingredients andexcipients, and implementation of good manufacturing practices.

Recommendations• Countries are encouraged to implement the new WHO good

trade and distribution practices, intended to improve safety inthe trade of starting materials for pharmaceutical use.

• Member States are encouraged to implement a pilot phase ofthe new WHO certification scheme for pharmaceutical start-ing materials which will give additional information on thequality assurance system used in the production of startingmaterials.

• WHO should continue the Prequalification Project of medi-cines for priority diseases, particularly HIV, malaria and tuber-culosis.

• WHO should foster collaboration between manufacturersand regulators in the implementation of GMP and providetraining.

• WHO should continue to develop international guidelines forregistration of multisource (generic) products.

Implications of regulatory decisionsfor pharmacoeconomicsThe mandate of regulatory agencies is to promote and protect publichealth by ensuring that all medicines entering the market meet qual-ity criteria, are safe and effective. The particular expertise of nationalregulatory authorities may make a valuable contribution to decisions


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on the cost effectiveness and rational use of medicines with regardto pharmacoeconomics and pricing. In countries with limited re-sources it is difficult to avoid direct involvement of national regula-tory authorities in pharmacoeconomics due to their unique knowl-edge base.

Recommendations• Where national regulatory agencies do not have pricing

responsibilities, they should ensure that all informationabout safety and efficacy needed to conduct economic evalu-ation is made available to public bodies charged with reim-bursement or pricing responsibilities.

• WHO should further support national regulatory authoritiesin introducing, wherever needed, elements which will con-tribute to pharmaco-economic evaluation.

• WHO should carry out an analysis on the affordability ofmedicines, particularly in developing countries experiencingsuch problems. WHO should collect and make available toMember States information on various pricing options andmechanisms, examples of impact of inadvertent marketingstrategies to medicines expenditure and potential publichealth implications of implementation of the TRIPS agree-ment.

• WHO should support pharmacoeconomic studies based onscientific methodology in countries and regions. Countriesundertaking pharmacoeconomic studies are encouraged topresent outcomes during the next ICDRA.

• Member States should study the potential of using objectivemeasurement units such as defined daily doses (DDD) formonitoring drug utilization and using these data for develop-ing rational national policies for pricing and increased accessto essential medicines.

Current topicsThe current topics session provides an opportunity to all regulatorsat the ICDRA to express their views on the newly-emerging topicswhich have not been reflected in the conference programme. Often,the topics raised in this session lead to substantial discussion duringsubsequent ICDRAs.


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Recommendations• The full flexibility of the TRIPS agreement to improve access

to medicines should be explored by countries. Countriesshould not voluntarily exceed TRIPS obligations which couldlimit flexibility and utility in protection of national publichealth interests.

• Member States should consider the potential impact of usagepatents on access and affordability of medicines.

• Countries should adopt the WHO Guidelines on DevelopingMeasures for Combating Counterfeit Drugs, raise public andpolitical awareness of the problem of counterfeiting, increasenational and international cooperation, data exchange be-tween all stakeholders, including national regulatory authori-ties, interested nongovernmental organizations, law enforce-ment agencies, industries, and relevant international organi-zations.

• WHO, in collaboration with other stakeholders, should de-velop a draft concept paper for an international convention oncounterfeit drugs. WHO should convene a meeting of nationalregulatory authorities to discuss further the concept paperand related issues before the next ICDRA.

• The comparator product for a multisource (generic) medicineshould be the first product registered in the market with acomplete data file available. In case the originator is notavailable on the market and there is no multisource (generic)market leader, then other appropriate solutions should beconsidered on case by case basis.

• Doping in sports is a serious health problem and is within theremit of drug regulation. National regulatory authoritiesshould remain vigilant and provide the necessary resources tocombat such practices.


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Albania

Pr. Vladimir MargjekaNational Centre of Drug ControlT: 355 43 72 892F: 255 43 72 892E-mail: [email protected]

Andorra

Ms. Carmen PallarésDepartment of Pharmacy, Productsand Health CentresMinistry of Health and WelfareT: 376 86 03 45F: 376 86 19 33E-mail: [email protected]

Angola

Dr. María de Fátima de Lima ViegasDireccao Nacional de MedicamentosT: 244 239 4153F: 244 233 2314E-mail: [email protected]

Argentina

Dr. Manuel Rodolfo LimeresAdministración Nacional de Medicamentos,Alimentos y Tecnología Médica - ANMATT: 54 11 43 40 0899F: 54 11 43 40 0800 1103E-mail: [email protected]

Dr. Hela Guadalupe BeltraminiDirección de Planificación y RelacionalesInstitucionalesAdministración Nacional de Medicamentos,Alimentos y Tecnología Médica - ANMATT: 54 11 43 42 8684E-mail: [email protected]

Dr. Carlos ChialeINAME, Administración Nacional deMedicamentos, Alimentos y Tecnología Médica -ANMATT: 54 11 43 40 0800E-mail: [email protected]

Dr. Patricia SaidonBVA Mallón de MedicamentosAdministración Nacional de Medicamentos,Alimentos y Tecnología Médica - ANMATT: 54 11 43 40 0899E-mail: [email protected]

Ms. Sonia Gabrilla TarragonaUnidad de Investigación Estrategia en SaludANMAT (Administración Nacional deMedicamentos y Tecnología Médica)T: 54 11 43 79 9171F: 54 11 43 47 41 51E-mail: [email protected]

Armenia

Ms Anahit AroyanMinistry of HealthT: 374 1 52 88 72F: 374 1 56 27 83E-mail: [email protected]

Dr. Tamara MirzoyanMinistry of HealthT: 374 1 52 88 72F: 374 1 56 27 83E-mail: [email protected]

Australia

Dr. Graham DicksonEvaluation UnitDrug Safety and Evaluation BranchTherapeutic Goods AdministrationT: 612 623 281 13 F: 612 623 281 40E-mail: [email protected]

Austria

Dr. Christa Wirthurmer-HocheLicensing DivisionPharmacy Regulatory AffairsFederal Ministry of Health and WomenT: 43 17 11 00 41 32F: 43 17 14 92 22E-mail: [email protected]

List of Participants


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Azerbaijan

Dr. Abulfaz Abdulla-zadaCentral Control LaboratoryControl of Medicines QualityMinistry of HealthT: 994 12 93 10 33F: 994 12 98 72 60E-mail: [email protected]

Bahrain

Ms. Layla A. RahmanPharmacy & Drug ControlMinistry of HealthT: 973 258 668F: 973 259 357E-mail: [email protected]

Bangladesh

Dr. Abddul GhaniDirectorate of Drugs AdministrationMinistry of Health & Family WelfareT: 880 2 9556 126F: 880 2 9568 166E-mail: [email protected]

Barbados

Mr. David CrawfordDrug InspectorateBarbados Drug ServiceT: 1 246 427 83 09F: 1 246 429 69 80E-mail: [email protected]

Ms. Maryam HindsBarbados Drug ServiceT: 1 246 435 9291F: 1 246 429 69 80E-mail: [email protected]

Belarus

Ms. Ludmila ReutskayaPharmacy DepartmentMinistry of HealthT: 375 17 2227 081F: 375 17 2227 081E-mail: [email protected]

Bhutan

Mr. Rinchen DorjiDrug, Vaccines & Equipment DivisionDepartment of Medical ServicesMinistry of HealthT: 975 02 32 54 58F: 975 02 32 38 09E-mail: [email protected]

Bosnia and Herzegovina

Dr. Aida MehmedagicInstitute for Quality Control of MedicinesT: 387 33 27 93 51F: 387 33 211 279E-mail: [email protected]

Dr. Bigana Tubic RatcovicDrug Agency of Republic of SRPSKAMinistry of Health and Social WelfareT: 387 51 465 357F: 387 51 303 480E-mail: [email protected]

Botswana

Dr. Sinah SeleloDrug Regulatory UnitMinistry of HealthT: 267 3180 864F: 267 3953 100E-mail: [email protected]

Brazil

Dr. Dirceu Raposo de MeloAgencia Nacional de Vigilancia SanitariaT: 55 61 448 12 05F: 55 61 448 12 54E-mail: [email protected]

Dr. Davi RumelDADRUAgencia Nacional de Vigilancia SanitariaT: 55 61 448 14 47F: 55 61 448 14 89E-mail: [email protected]


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Dr. Beatriz Mc Dowell SoaresGerencia General, Sangue e Tecidos Células e ÓrgaosAgencia Nacional de Vigilancia SanitariaT: 55 61 448 1370F: 55 61 448 1355E-mail: [email protected]

Mr. Jose Antonio de Faria VilaçaGerencia General Sanguee Tecidos Células e ÓrgaosAgencia Nacional de Vigilancia SanitariaT: 21 61 448 1316F: 21 61 448 1355E-mail: [email protected] Darussalam

Ms. Siti Mariam JaafarPharmaceutical ServicesMinistry of HealthT: 673 23 00 41F: 673 23 00 41E-mail: [email protected]

Ms. Rosni JairPharmaceutical ServicesMinistry of HealthT: 673 23 00 41F: 673 23 00 41E-mail: [email protected]

Bulgaria

Dr. Tatyana BenishevaNational Health PolicyMinistry of HealthT: 359 2 9301 246F: 359 2 987 5186E-mail: [email protected]

Mr. Lubomir ChipilskiBulgarian Drug AgencyT: 359 29 44 38 36F: 359 29 43 44 87E-mail: [email protected]

Burkina Faso

Dr. Mahamadou CompaoreServices PharmaceutiquesT: 226 20 38 66F: 226 31 44 76E-mail: [email protected]

Cambodia

Dr. Phana ChhiengBureau of Drug and CosmeticsFood and Drug DepartmentMinistry of HealthT: 855 23 88 02 47F: 855 23 88 02 47E-mail: [email protected]

Dr. Sokhan ChroengFood and Drug DepartmentT: 855 12 862 010F: 855 23 88 0696E-mail: [email protected]

Dr. Phyrum UngSecretary of StateMinistry of HealthF: 855 23 42 68 41E-mail: [email protected]

Cameroon

Dr. Emilienne Yissibi PolaPharmacie et du MedicamentT: 237 222 4144E-mail: [email protected]

Canada

Mr. Omer BoudreauTherapeutic ProductsHealth CanadaT: 1 613 952 46 19F: 1 613 952 77 56E-mail: [email protected]

Dr. Antonio GiuliviHealth Safety Surveillance of Health Care Ac-quired InfectionsHealth CanadaT: 1 613 957 1789F: 1 613 952 6668E-mail: [email protected]

Ms. Julia HillBiologics and Genetic Therapies DirectorateHealth CanadaT: 1 613 957 80 65F: 1 613 957 16 79E-mail: [email protected]


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Dr. Robert PetersonTherapeutic ProductsHealth CanadaT: 1 613 957 64 66F: 1 613 952 77 56E-mail: [email protected]

Dr. Duc VuNatural Health Products Division (MHPD)Health CanadaT: 1 613 952 93 01F: 1 613 948 21 01E-mail: [email protected]

Mr. Mike Ward International Programs DivisionTherapeutic Products DirectorateT: 1 613 952 66 19F: 1 613941 9672E-mail: [email protected]

Chile

Mr. Carlos Ivan Manzi AstudilloDirección Central de Abastecimiento del SistemaNacional de Servicio de la SaludT: 56 2 55 04 701F: 56 2 55 50 849E-mail: [email protected]

Dr. Rodrigo SalinasNational Institute of HealthT: 56 2 350 73 08F: 56 2 350 75 70E-mail: [email protected]

China

Mr. Zhenjia BianDepartment of Drug Safety and InspectionState Food and Drug AdministrationT: 86 10 8836 3230F: 86 10 8836 3230E-mail: [email protected]

Mr. Anthony Wing Kin ChanDepartment of HealthHong Kong Special Administrative RegionT: 852 2319 8500F: 852 2834 5117E-mail: [email protected]

Mr. Wenzuo ChangDepartment of International CooperationState Food and Drug AdministrationT: 86 10 8836 3219F: 86 10 6831 5648

Ms. Xingyu ChenDepartment of International CooperationState Food and Drug AdministrationT: 86 10 6831 1986F: 86 10 6833 7662E-mail: [email protected]

Mr. Xu ChenDepartment of Drug Market ComplianceState Food and Drug AdministrationT: 86 10 6831 3344 0952F: 86 10 8836 3243E-mail: [email protected]

Mr. Terry, Peng Cheong ChoiDivision of Pharmacovigilence andPharcoeconomiesHealth Services of MacaoT: 853 598 35 19F: 853 52 40 16E-mail: [email protected]

Dr. Kit Lim Cindy LaiDepartment o f HealthHong Kong Special Administrative RegionT: 852 2961 8892F: 852 2573 0646E-mail: [email protected]

Dr. Ping Yan LamDepartment o f HealthHong Kong Special Administrative RegionT: 852 2961 8888F: 852 2893 9613E-mail: [email protected]

Dr. Ruichao LinDivision of Chinese Materia Medicaand Natural ProductsNational Institute for the Controlof Pharmaceutical and Biological ProductsT: 86 10 6702 3650F: 86 10 6702 3650E-mail: [email protected]


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Ms. María Noémia Marques RodriguesPharmaceutical AffairsHealth DepartmentMacao S.A.R.T: 853 52 40 58F: 853 52 40 16E-mail: [email protected]

Ms. Ilda Maria Ferreira de OliveiraHealth DepartmentMacao Special Administrative RegionT: 853 390 71 49F: 853 71 31 05E-mail: [email protected]

Mr. Xiaoling QinDepartment of International CooperationState Food and Drug AdministrationT: 86 10 6831 3344 0582F: 86 10 6831 56 48

Mr. Mingli ShaoState Food and Drug AdministrationT: 86 10 6831 1986F: 86 10 6833 7662

Mr. Dianjun SuiJi Lin Provincial Food and Drug AdministrationnT: 86 0431 2763 973F: 86 10 8836 3230E-mail: [email protected]

Mr. Guorong WangChinese Pharmacopoeia CommissionT: 86 10 6715 2768F: 86 10 6715 2766E-mail: [email protected]

Mr. Zhang XianglinDrug Evaluation CenterState and Food and Drug AdministrationF: 86 10 6858 4217E-mail: [email protected]

Mr. Xiaoming ZhaoDepartment of Drug Market ComplianceState Food and Drug AdministrationT: 86 10 6831 3344 0901F: 86 10 8836 3221E-mail: [email protected]

Ms. Lili ZhaoDepartment of International CooperationState Food and Drug AdministrationT: 86 10 6831 8660F: 86 10 6831 8660E-mail: [email protected]

Mr. Xiayou ZhengState and Food AdministrationF: 86 10 6831 5648E-mail: [email protected]

Mr. Zhang ZhijunDepartment of Drug RegistrationState and Food AdministrationT: 86 10 6833 7660F: 86 10 8836 3236E-mail: [email protected]

Colombia

Dr. Julio César Aldana BulaDirección General INVIMAMinisterio de la Protección SocialT: 1 41 0216F: 1 2948 700 EXT. 3896E-mail: [email protected]

Congo

Dr. Jerome MpatiServices medecine traditionnelleDirection des Service SanitairesE-mail:[email protected]

Costa Rica

Dr. Marielos Morales VegaDirección Registros y ControlesMinisterio de SaludT: 506 221 60 58F: 506 221 14 20E-mail: [email protected]

Croatia

Dr. Velimir BozikovDepartment of Internal MedicineDubrava University HospitalT: 385 1 290 2420F: 385 1 286 3652E-mail: [email protected]


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Cuba

Dr. Celeste Aurora Sánchez GonzálezCentro para el Control Estatal de la Calidad delos MedicamentosT: 53 7 271 40 23F: 53 7 271 40 23E-mail: [email protected]

Czch Repbulic

Dr. Milan SmidState Institute For Drug ControlT: 420 26 71 11 53F: 420 27 27 39 95E-mail: [email protected]

Denmark

Ms. Jytte LynvvigDanish Medicines AgencyT: 45 44 88 95 55F: 45 44 88 95 59E-mail: [email protected]

Eritrea

Mr. Asgedom Mosazghi HagosMedicines ControlRegulatory ServicesMinistry of HealthT: 291 1 12 23 36F: 291 1 12 28 99E-mail: [email protected]

Estonia

Ms. Kristin RaudseppState Agency of MedicinesT: 372 737 4140F: 372 737 4142E-mail: [email protected]

Ethiopia

Mr. Teferi Mengistab W.AregayDrug Control and Abuse PreventionT: 251 1 52 41 18F: 251 1 52 13 92E-mail: [email protected]

France

Dr. Pierrelte ZorziDepartment for Biological Products EvaluationAgence française de Sécurité Sanitaire desProduits de SantéT: 33 1 5587 3500F: 33 1 5587 3492E-mail: [email protected]é.fr

Gambia

Mr. Sillah BubakarDepartment of State for HealthT: 220 22 53 78E-mail: [email protected]

Dr. Mariatou Tala JallowMedicines BoardDepartment of State for HealthT: 220 22 53 74F: 220 22 58 73E-mail: [email protected]

Georgia

Mr. Alexander TomadzeDrug and Pharmacy DepartmentMinistry of HealthT: 995 32 25 06 32F: 995 32 25 00 61E-mail: [email protected]

Germany

Dr. Christian BehlesFederal Institute for Drugs and Medical DevicesT: 49 228 207 33 85F: 49 228 207 57 65E-mail: [email protected]

Dr. K. KellerFederal Institute for Drugs and Medical DevicesT: 49 228 207 33 85F: 49 228 207 57 65E-mail: [email protected]

Dr. Gottfried KreutzFederal Institute for Drugs and Medical DevicesT: 49 228 207 3489F: 49 228 207 3534E-mail: [email protected]


55

Prof. Johannes LöwerPaul-Erlich-InstitutT: 49 61 03 77 1000F: 49 61 03 77 12 40E-mail: [email protected]

Ghana

Mr. Emmanuel Kwabena AgyarkoFood and Drugs BoardT: 233 21 66 09 89F: 233 21 66 03 89E-mail: [email protected]

Mr. Michael F. Awuku-KwatiaPharmacy Council of GhanaT: 233 21 678 538F: 233 21 229 573E-mail: [email protected]

Mr. Ben Kwame BotweDrugs DivisionFood and Drugs BoardT: 233 21 673 090F: 233 21 660 389E-mail: [email protected]

Guinea Equatorial

Ms. Consuelo Ondo EfuaAprovisionamiento de MedicamentosT: 240 9213F: 233 21 660 389E-mail: [email protected]

Mr. Tomás MechaMinistro Felegado

Mr. Ismael Mguema EssengDireccion General de Farmacia y MedicinaTradicionalMinistry of HealthT: 240 91 196F: 240 93 236

Haiti

Ms. Rosemond MagalieDirection de PharmacieMinistère de la Santé PubliqueT: 513 6005 404 9597E-mail: [email protected]

Honduras

Ms. Miriam Elisabeth PinedaDepartamento de FarmaciaSecretaria de la SaludT: 504 237 57 76F: 504 237 5776E-mail: [email protected]

Hungary

Pr. Tamas PaalNational Institute of PharmacyT: 36 1 317 1462F: 36 1 317 40 44E-mail: [email protected]

Iceland

Mr. Ingolf PetersenPharmaceutical AffairsMinistry of Health and Social SecurityT: 354 545 8700F: 354 551 9165E-mail: [email protected]

India

Dr Ashwini KumarDirectorate General of Health ServicesMinistry of Health & Family WelfareT: 91 11 2301 8806F: 91 11 2301 2648E-mail: [email protected]

Indonesia

Dr. H. SampurnoNational Agency of Drug and Food ControlT: 62 21 424 46 88F: 62 21 425 07 64E-mail: [email protected]

Dr. Lucky Suryadi SlametTherapeutic and Narcotic, Psychotropicand Addictive Substance ControlNational Agency of Drug and Food ControlT: 62 21 42 44 755F: 62 21 42 43 605E-mail: [email protected]


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Iran

Dr. A. Majid CheraghaliFood and DrugMinistry of HealthT: 98 21 646 72 66F: 98 21 670 58 68E-mail: [email protected]

Israel

Ms. Batya Haran ShaharbaniPharmaceutical DivisionMinistry of HealthT: 972 2 568 12 12F: 972 2 672 58 20E-mail: [email protected]

Italy

Mr. Antonio G.M. AddisDirezione Generale dei Farmaci e DispositiviMediciMinisterio della SaluteT: 39 06 5994 3085F: 39 06 5994 3117E-mail: [email protected]

Jamaica

Ms. Princess Thomas OsbourneStandards & RegulationMinistry of HealthT: 876 948 4206F: 1 876 967 1629E-mail: [email protected]

Japan

Dr. Yoshikazu HayashiEvaluation and Licensing DivisionPharmaceutical and Food Safety BureauMinistry of Health, Labour and WelfareT: 81 3 3595 2431F: 81 3 3597 9535E-mail: [email protected]

Dr. Suichi KishidaEvaluation and Licensing DivisionPharmaceutical and Food Safety BureauMinistry of Health, Labour and WelfareT: 81 3 3595 2431F: 81 3 3597 9535E-mail: [email protected]

Repbulic of Korea

Dr. Seong Ho KimPharmaceutical Safety DivisionKorea Food & Drug AdministrationT: 82 2 380 1849F: 82 2 359 6965E-mail: [email protected]

Dr. Soon Wook HongBio-Pharmaceutical DivisionKorea Food & Drug AdministrationT: 82 2 380 1540F: 82 2 388 6456E-mail: [email protected]

Dr. Youn Chan JungKorea Food & Drug AdministrationT: 82 2 380 1606F: 82 2 386 0843E-mail: [email protected]

Dr. Young Ok KimDrug EvaluationKorea Food & Drug AdministrationT: 82 2 380 1721F: 82 2 380 1723E-mail: [email protected]

Dr. Hong Ki MinBiologics EvaluationKorea Food & Drug AdministrationT: 82 2 380 1684F: 82 2 383 8322E-mail: [email protected]

Dr. Yeowon SohnDivision of BiotechnologyKorea Food & Drug AdministrationT: 82 2 382 1739F: 82 2 383 83 22E-mail: [email protected]

Dr. Tae Moo YooDivision of PharmacologyKorea Food & Drug AdministrationT: 82 2 380 1807F: 82 2 380 1807E-mail: [email protected]

Dr. Dong Hee YooInternational Trade and Information OfficeKorea Food & Drug AdministrationT: 82 2 380 1648F: 82 2 356 2893E-mail: [email protected]


57

Kyrgyzstan

Dr. Rustam KurmanovDrug Provision and Medical EquipmentMinistry of HealthT: 996 312 54 29 10F: 996 312 54 29 10E-mail: [email protected]

Lao People‘s Democratic Republic

Mr. Douangsavanh SavengvongFood and Drug DepartmentT: 856 21 401 34F: 856 21 21 40 15E-mail: [email protected]

Mr. Sivong SengaloundethNational Drug Policy ProgrammeFood and Drug DepartmentT: 856 21 561 985F: 856 21 21 40 15E-mail: [email protected]

Latvia

Dr. Janis OzolinsState Agency of MedicinesT: 371 707 84 00F: 371 707 84 28E-mail: [email protected]

Lesotho

Ms Nomaphuthi HoohioPharmaceutical Services DepartmentMedicines Control AuthorityT: 266 63 03 22 53F:266 22 31 07 90E-mail: [email protected]

Ms Teboho KhetsiPharmaceutical Services DepartmentMedicines Control AuthorityT: 266 58 84 32 35F:266 22 31 07 90E-mail: [email protected]

Mr Matabele SefaliPharmaceutical Services DepartmentMedicines Control AuthorityT: 266 58 86 81 6F:266 22 70 13 40E-mail: [email protected]

Liberia

Mr. Tijli Tarty TyeePharmacy Board of LiberiaT: 231 558097

Libya

Dr. Emhemmed Mohammed KhshebaNarcotic & PsychotropicsPharmaceutical & Medical Equipment Co.T: 218 21 36 015 68F: 218 21 36 015 86E-mail: [email protected]

Republic of Macedonia

Ms. Vesna Nasteska-NedanovskaPharmaceutically Regulatory AffairsDrug BureauT: 389 2 3 237 669F: 389 2 3 113 014

Mr. Romil SandzakoskiDrug BureauT: 389 2 3 227 195F: 389 2 3 113 014

Madagascar

Mr. Jean René RandriasamimananaAgence du MédicamentMinistère de la SantéT: 26 12 022 365 22F: 26 12 022 642 28E-mail: [email protected]

Malawi

Mr. Patrick Simon Peter TemboPharmacy, Medicines and Poisons BoardT: 265 01 755 634F: 265 01 755 204E-mail: [email protected]

Malaysia

Ms. Hasiah AbdullahNational Pharmaceutical Control BureauT: 603 795 67 361F: 603 795 67 075E-mail: [email protected]


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Mr. Che Awang Che Mohd Zin Pharmaceutical ServicesT: 603 796 82 210F: 603 796 82 222E-mail: [email protected]

Dr. Abida HaqNational pharmaceutical Control BureauT: 603 7957 3611F: 603 795 67151E-mail: [email protected]

Dr. Eisah RahmanNational Pharmaceutical Control BureauT: 603 795 73 611F: 603 795 81 312E-mail: [email protected]

Maldives

Dr. Aishath IbrahimEssential Drugs And alternative MedicinesT: 960 32 45 22F: 960 32 88 89E-mail: [email protected]

Mali

Mr. Gaoussou KanoutéLaboratoire national de la SantéT: 223 222 4770F: 223 223 2281E-mail: [email protected]

Mauritius

Mr. Gerard RequinPharmaceutical ServicesPharmacy, Drug Regulation and Overall man-agementMinistry of Health and Quality of LifeT: 230 201 1334F: 230 201 3891E-mail: [email protected]

Mexico

Dr. Carmen BecerrilSecretaría de SaludT: 52 55 50 80 54 51F: 52 55 55 14 85 81E-mail: [email protected]

Dr. Alberto FratiScientific CommitteeComisión Federal para la Protección contraRiesgos Sanitarios, Secretaría de la SaludT: 52 55 5080 5353F: 52 55 55111 499E-mail: [email protected]

Republic of Moldova

Dr. Larisa CatriniciMinistry of HealthF: 373 22 73 8781E-mail: [email protected]

Morocco

Dr. Haouach ImaneNational Laboratory for Drug Control-Direction du Medicament et de la PharmacieT: 212 6369 9841F: 212 3777 2520

Mozambique

Mr. Joaquim DuraoPharmaceutical DepartmentMinistry of HealthT: 258 1 32 6547F: 258 1 303 473E-mail: [email protected]

Dr. Alexandre MangueleDirectorate of HealthMinistry of HealthT: 258 82 303 360F: 258 13 261 64E-mail: [email protected]

Namibia

Mr. Johannes GaesebHealth Care ServicesMinistry of Health and Social ServicesT: 264 61 203 23 50F: 264 61 203 23 49E-mail: [email protected]

Ms. Dinah Jorokee ThijoDrug ControlMinistry of Health & Social WelfareT: 264 61 203 23 91F: 264 61 203 23 49E-mail: [email protected]


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Nepal

Mr. Teli Radha Raman PrasadDepartment of Drug AdministrationT: 977 1 4780 432/227F: 977 1 4780 572E-mail: [email protected]

Netherlands

Ms. Désirée Hoefnagel International AffairsPharmaceutical and Medical TechnologiesMinistry of Health, Welfare and SportT: 31 70 34 05 542F: 31 70 3407187E-mail: [email protected]

Mr. Frits LekkerkerkerMedicines Evaluation BoardT: 31 70 356 74 48F: 31 70 356 75 15E-mail: [email protected]

Mr. John LismanMedicines Evaluation BoardT: 31 70 356 74 82F: 31 70 356 75 15E-mail: [email protected]

Netherlands Antilles

Mr. Peter H. M. FontilusInspectorate of Public HealthT: 599 9 7374877F: 599 9 7374844E-mail: [email protected]

New Zealand

Mr. Derek FitzgeraldMedicines and Medical Devices Safety Authori-ties (MEDSAFE)T: 644 496 2176F: 644 496 22 29E-mail: [email protected]

Dr. Stewart Sinclair JessamineMedicines Regulation and Pharmacy VigilanceMedicines and Medical Devices Safety Authori-ties (MEDSAFE)T: 644 496 22 74F: 644 496 22 29E-mail: [email protected]

Nicaragua

Ms. Alma Nubia Lacayo CastilloRegistro SanitarioMinisterio de Salud de NicaraguaT: 505 289 4401F: 505 289 4401E-mail: [email protected]

Dr. Marcia Vega PasquierAcreditación y Regulación de Medicinas yAlimentosMinisterio de Salud de NicaraguaT: 505 289 4401F: 505 289 4401E-mail: [email protected]

Niger

Dr. Sani IssaDirection Générale de la PharmacieT: 227 97 48 67F: 227 73 35 70E-mail: [email protected]

Nigeria

Dr. Dora AkunyiliNational Agency for Foodand Drug Administration and ControlT: 234 9 524 09 94F: 234 9 524 09 94E-mail: [email protected]

Ms Emem EtokebeNational Agency for Food and Drug Administra-tion and ControlT: 234 9 524 09 94F: 234 9 524 09 94E-mail: [email protected]

Mr. Joseph NwoyeNational Agency for Food and Drug Administra-tion and ControlT: 234 9 524 09 94F: 234 9 524 09 94E-mail: [email protected]

Mr. Declan UgwuNational Agency for Food and Drug Administra-tion and ControlT: 234 9 524 09 94F: 234 9 524 09 94E-mail: [email protected]


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Norway

Mr. Per Olav RoksvaagNorwegian Medicines AgencyT: 47 97 68 4501F: 47 22 89 7799E-mail: [email protected]

Pakistan

Dr. Farzana ChowdharyDrugs OrganizatiosnMinistry of HealthT: 9202566F: 9205481E-mail: [email protected]

Dr. F.R. Yousuf FazliMinistry of HealthT: 92 51 227 09 85F: 92 51 227 69 56E-mail: [email protected]

Papua New Guinea

Mr. Vali KaroMedical Supplies BranchT: 675 301 3886E-mail: [email protected]

Portugal

Ms. Paula Alexandra Ferreira da CostaINFARMED-DAICT: 351 21 798 71 00E-mail: [email protected]

Ms. Ana María MirandaLicensing and Inspection DepartmentINFARMEDT: 351 21 798 52 74F: 351 21 798 72 57E-mail: [email protected]

Ms. María MoraisCommunity Affairs, Co-operation and Interna-tional RelationsINFARMEDT: 351 21 798 72 46F: 351 21 798 71 07E-mail: [email protected]

Dr. Rui dos Santos IvoINFARMEDHealth MinistryT: 35 121 79 87 109F: 35 121 79 87 120E-mail: [email protected]

Romania

Dr. Rodica BadescuNational Medicines AgencyT: 40 21 224 10 79F: 40 21 224 34 97E-mail: [email protected]

Saudi Arabia

Mr. Ibrahim AlshowaierDirector of Medical and Pharmaceutical LicencesMinistry of HealthT: 966 55 47 56 62F: 966 14 02 98 91E-mail: [email protected]

Senegal

Dr. Rokhaya Ndiaye KandeDirection de la Pharmacie et des LaboratoiresT: 822 4470

Serbia and Montenegro

Ms. Natasa MoravcevicDepartment for International RelationsMinistry of HealthT: 381 63 844 3177F: 381 11 361 4890E-mail: [email protected]

Sierra Leone

Mr. Michael Jack LansanaPharmacy Board of Sierra LeonaT: 232 22 229346F: 232 22 224526E-mail: [email protected]

Singapore

Dr. John C. W. LimCentre for Drug AdministrationHealth Sciences AuthorityT: 65 632 55 616F: 65 632 55 423E-mail: [email protected]


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Dr. Chor Hiang TanHealth Science AuthorityT: 65 621 30 889F: 65 621 30 841E-mail: [email protected]

Mr. Kelvin Choon Yen TanProsecution UnitCentre for Drug AdministrationHealth Sciences AuthorityT: 65 632 55 496F: 65 632 55 628E-mail: [email protected]

Slovakia

Dr. Ludevit MartinecState Institute for Drug ControlT: 421 2 5556 5881F: 421 2 5556 4127E-mail: [email protected]

South Africa

Dr. Shabir BanooMedicines Control CouncilDepartment of HealthT: 27 83 786 9854F: 27 12 312 0214E-mail: [email protected]

Dr. Frank HlangwaneMedicines Evaluation and ResearchDepartment of HealthT: 27 12 312 0214F: 27 12 312 3104E-mail: [email protected]

Spain

Dr F. Garcia AlonsoDirectorate General for pharmacyMinistry of HealthT: 34 596 40 15F 34 596 40 07E-mail: [email protected]

Dr. Carlos Lens CabreraSpanish Agency for Medicines and HealthcareProductsT: 34 91 822 50 28F: 34 91 822 50 10E-mail: [email protected]

Dr. Ramón PalopSpanish Agency for Medicines and HealthcareProductsT: 34 91 596 77 01F: 34 91 59678 01E-mail: [email protected]

Dr. Francisco de Abajo IglesiasDivisión Farmacología y Evaluación ClínicaSpanish Agency for Medicines and HealthcareProductsT: 34 91 596 77 10F: 34 91 596 78 91E-mail: [email protected]

Mr Manuel Ibarra LorenteMedicines InspectorateSpanish Agency for Medicines and HealthcareProductsT: 34 918225222F: 34 91 822 52 43E-mail: [email protected]

Ms. Teresa Milán RusilloMedicinal Products for Human UseSpanish Agency for Medicines and HealthcareProductsT: 34 91 822 50 73F: 34 822 51 61E-mail: [email protected]

Ms. Blanca Miranda SerranoOrganización Nacional de TrasplantesT: 34 91 314 24 06E-mail: [email protected]

Dr. Alfonso Moreno GonzálezServicio de FarmacalogíaHospital Clínico San CarlosT: 34 91 330 34 13F: 34 91 330 32 57

Dr. Jose Félix OlallaSpanish Agency for Medicines and HealthcareProductsT: 34 91 822 51 37F: 34 91 822 51 27E-mail: [email protected]


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Ms. Hortensia SegrellesInternational Affairs DivisionSpanish Agency for Medicines and HealthcareProductsT: 34 91 822 50 40F: 34 91 822 51 28E-mail: [email protected]

Ms. Alexandra Vardulaki OpermanSafety General SubdirectionSpanish Agency for Medicines and HealthcareProductsT: 34 918225207F: 34 91 822 52 43E-mail: [email protected]

Ms. María Teresa Barea FlórezSpanish Agency for Medicines and HealthcareProductsT: 34 91 822 50 28F: 34 91 822 50 10E-mail: [email protected]

Ms. Patricia Barea GalánInternational Affairs DivisionSpanish Agency for Medicines and HealthcareProductsT: 34 91 822 51 38F: 34 91 822 51 28E-mail: [email protected]

Sudan

Mr. Salan Eldin Abdelrahman Abdel AzizGeneral Directorate of PharmacyFederal Ministry of HealthT: 249 11 77 56 97F: 249 11 77 29 70E-mail: [email protected]

Mr. Zain-Elaboin MohamedDepartment of PhamarcyFederal Ministry of HealthT: 249 11 77 56 97F: 249 11 77 29 70E-mail: [email protected]

Sweden

Dr. Jane Ahlquist RastadMedical Products AgencyT: 46 18 17 48 80F: 46 18 18 36 12E-mail: [email protected]

Dr. Björn BeermannInformation and Drug UitlisationMedical Products AgencyT: 46 18 1746 00E-mail: [email protected]

Switzerland

Dr. Klaus-Jörg DogwilerSwiss Agency fot Therapeutic Products,SwissmedicT: 41 31 322 02 01F: 41 31 322 04 30E-mail: [email protected]

Dr. Christian SchaererSwiss Agency fot Therapeutic Products,SwissmedicT: 41 31 324 25 11F: 41 31 324 25 07E-mail:

Dr. Rolf SpangInternational AffairesSwiss Agency fot Therapeutic Products,SwissmedicT: 41 31 322 04 44F: 41 31 322 02 12E-mail: [email protected]

Syria

Dr. Souhila HakeimPharmaceutical AffairsMinistry of HealthT: 963 11 33 211 58F: 963 11 33 211 58E-mail: [email protected]

Dr. Razan KudciDrug RegistrationPharmaceutical AffairsMinistry of HealthT: 963 11 33 211 58F: 963 11 33 211 58E-mail: [email protected]

Tajikistan

Mr. Isupov SalomudinDepartment of PharmaceuticalsMinistry of HealthT: 992 372 21 67 07F: 992 372 21 48 71E-mail: [email protected]


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United Republic of Tanzania

Dr. Nditonda Benno ChukilizoDrug RegistrationProduct Evaluation and RegistrationTanzania Food and Drug AuthorityT: 255 22 2450 512F: 255 22 2450 793E-mail: [email protected]

Mr. Henry IrundePublic Education and InformationTanzania Food and Drug AuthorityT: 255 22 2450 751F: 255 22 2450 793E-mail: [email protected]

Mr. Erasto Sokia Theobadi MoshaDrug InspectionTanzania Food and Drug AuthorityT: 255 22 2450 512F: 255 22 2450 793E-mail: [email protected]

Ms. Zera MsuyaQuality Control LaboratoryTanzania Food and Drug AuthorityT: 255 22 2450 751F: 255 22 2450 793E-mail: [email protected]

Mr. Joseph Salinga MuhumeMinistry of HealthT: 255 22 21 20 261F: 255 22 2450 793E-mail: [email protected]

Dr. Leonard Gabriel UpundaMinistry of HealthT: 255 22 21 20 261F: 255 22 2450 793E-mail: [email protected]

Thailand

Dr. Supachai KunaratanaprukFood and Drug AdministrationMinistry of Public HealthT: 66 2 590 7052F: 66 2 591 8636E-mail: [email protected]

Ms. Krisanaphan CharuneeDrug Control DivisionFood and Drug Administration, Ministry of HealthT: 66 2 590 7196F: 66 2 591 8465E-mail: [email protected]

Mr. Aphichai HoonchamlongDrug Control DivisionFood and Drug AdministrationT: 66 2 59 07 315F: 66 2 59 18 489E-mail: [email protected]

Togo

Mr. NyansaDirection Generale de la Santé PubliqueT: 228 22 07 99

Tunisia

Ms. Dalila DarghouthPharmaceutical InspectionMinistry of HealthT: 216 71 560 444F: 216 71 573 023E-mail: [email protected]

Pr. Amour ToumiDirection de la Pharmacie et du MédicamentMinistère de la Santé PubliqueT: 216 71 79 68 24F: 216 71 79 78 16E-mail: [email protected]

Uganda

Mr. Gabriel Kayanja KadduNational Drug AuthorityT: 256 41 34 73 91F: 256 41 25 57 58E-mail: [email protected]

Dr. James MakumbiNational Drug AuthorityT: 256 41 34 73 91F: 256 41 25 57 58E-mail: [email protected]

Mr. Apollo Edson MuhairweNational Drug AuthorityT: 256 41 34 73 91F: 256 41 25 57 58E-mail: [email protected]


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Ukraine

Mr. Voodymir BortnyskyState Service of Drug RegulationMinistry of Health of UkraineT: 380 44 253 61 65F: 380 44 253 61 65E-mail: [email protected]

Mr. Mykhail PasichnykMinistry of Health of UkraineT: 380 44 253 61 65F: 380 44 253 61 65E-mail: [email protected]

United Kingdom

Pr Kent WoodsMedicines and Healthcare Products RegulatoryAgencyT: 44 207 084 2100F: 44 207 084 2584E-mail: [email protected]

United States of America

Dr. Jesse L. GoodmanCBERFood and Drug Administration (FDA)T: 1 301 827 0372F: 1 301 829 0440 E-mail:[email protected]

Dr. Justina A. Molzon International ProgramsCenter for Drugs (CDER)Food and Drug Administration (FDA)T: 1 301 594 5400F: 1 301 594 6197E-mail: [email protected]

Dr. Jill Hartzler WarnerCBERFood and Drug Administration (FDA)T: 1 301 827 0372F: 1 301 827 0440E-mail: [email protected]

Uzbekistan

Pr. Shakhnoza AzimovaHead Departmentr of Drugand Medical Equipment Quality ControlMinistry of HealthT: 998 71 144 00 01F: 998 71 144 48 25E-mail: [email protected]

Ms. Nazira Nazimovna BakhramovaDrugs PolicyMinistry of HealthT: 998 71 132 25 68F: 998 71 144 10 33E-mail: [email protected]

Dr. Nusratilla BerdievMedicaments Control UnitMinistry of HealthT: 998 712 4117 80F: 998 71 144 12 02E-mail: [email protected]

Ms. Gulchekhra BoltabaevaDepartment of Drug and Medical EquipmentQuality ControlMinistry of HealthT: 998 71 144 48 18F: 998 71 144 48 25E-mail: uzpharm@online

Ms. Dilya KurbanovaRFEE “Uzmdexport”Ministry of HealthT: 998 712 68 73 84F: 998 712 68 77 01E-mail: [email protected]

Pr. Akhmatkhodja YunuskhodjayevTashkent Pharmaceutical InstituteT: 998 712 56 37 38F: 998 712 56 45 04E-mail: [email protected]

Venezuela

Dr. Leopoldo Landaeta VargasJunta Revisora de Productos FarmacéuticosMinisterio de Salud y Desarrollo SocialT: 58 212 4080 519F: 58 212 4080 515E-mail: [email protected]

Vietnam

Ms. Ta Thi Phuc ChanDrug Administration DivisionT: 84 48 46 20 10F: 84 4 823 47 58E-mail: [email protected]


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Zimbabwe

Dr. Mafios DauramanziMedicines Control Authority of ZimbaweT: 263 4 736 981F: 263 4 736 980E-mail: [email protected]

Mr. Rutendo KuwanaMedicines Control (Licensing Unit)T: 263 4 736 981F: 263 4 736 980E-mail: [email protected]

Dr. Gugu Nolwandle MahlanguMedicines ControlT: 263 4 736 981 F: 263 4 736 980E-mail: [email protected]

Dr. Mabel TorongoMedicines Control Authority of ZimbaweT: 263 4 736 981F: 263 4 736 980E-mail: [email protected]

Other AgenciesEuropean Agency for the Evaluation of

Medicinal Products (EMEA)

Mr. Thomas LönngrenEuropean Agency for the Evaluationof Medicinal Products (EMEA)T: 44 207 41 88 406F: 44 207 41 88 409E-mail: [email protected]

Ms. Arielle NorthExecutive SupportEuropean Agency for the Evaluationof Medicinal Products (EMEA)T: 44 207 52 37 166F: 44 207 41 88 409E-mail: [email protected]

Pr. Klaus CichutekPaul-Erlich-Institut andEuropean Agency for the Evaluationof Medicinal Products (EMEA)T: 49 61 03 77 1000F: 49 61 03 77 12 40

European Commission

Dr. Paul WeissenbergDrug DepartmentEuropean CommissionT: 32 2 29 63 358F: 32 2 29 98 010E-mail: [email protected]

European Pharmacopoeia

Mr. Peter CastleDIV IEDQM, Council of EuropeT: 33 388 41 21 83F: 33 388 41 2771E-mail: [email protected]

Mme Agnes ArtigesEDQM, Council of EuropeT: 33 388 41 21 83F: 33 388 41 2771E-mail: [email protected]

Japanese pharmacopoeia

Dr. Goro FunamotoJapanese PharmacopeiaOrganization for Pharmaceutical SafetyT: 81 3 3506 9542F: 81 3 3506 9443E-mail: [email protected]

Dr. Yasushi TakedaJapanese PharmacopeiaT: 81 3 3400 5634F: 81 3 3400 5634E-mail: [email protected]

Mr. Motohide YoshiikeProduct Reviev DepartmentJapanese PharmacopeiaT: 81 3 3506 9542F: 81 3 3506 9443E-mail: [email protected]

United States Pharmacopeia

Dr. Lokesh BhattacharyyaInformation Standards DevelopmentT: 1 301 816 8210F: 1 301 816 8373E-mail: [email protected]


66

Mr. John FowlerInformation Standards DevelopmentT: 1 301 816 8527F: 1 301 816 8315E-mail: [email protected]

Dr. Eric SheininInformation Standards DevelopmentF: 1 301 816 83 73

Dr. Cecil ToddInformation Standards DevelopmentT: 1 301 816 8234F: 1 301 816 8373E-mail: [email protected]

Dr. Roger L. WilliamsUnited States PharmacopeiaT: 1 301 816 8300F: 1 301 816 8299E-mail: [email protected]

Medecins Sans Frontieres

Dr. Wilbert BannenbergPolicy ResearchMedecins Sans FrontieresNetherlands

Ms. Carmen Perez CasasMedecins Sans FrontieresSpain

Ms. Nora UrangaAccess to DrugsMedecins sans FrontièresT: 91 541 1375F: 91 542 0022E-mail: [email protected]

World Health Organization Regional Office

Africa

Dr. Ossy M.J. KassiloTraditional MedicineEssential Drugs and Medicines PolicyT: 47 241 39 268F: 47 241 39 511E-mail: [email protected]

Mr. Jean-Marie TrapsidaEssential Drugs and Medicines PolicyT: 47 241 39 258F: 47 241 39 511E-mail: [email protected]


Americas

Dr. Rosario D’AlessioPanamerican Health OrganizationT: 1 202 974 3921F: 1 202 974 3610E-mail: [email protected]


Europe

Mr. Kees de JoncheereHealth, Technology and PharmaceuticalsT: 45 39 17 14 32F: 45 39 17 18 55E-mail: [email protected]

Dr. Nina SautenkovaProgramme for pharmaceuticalsT: 45 2332 2266F: 45 3917 1855E-mail: [email protected]


South-East Asia

Dr. Krisantha WeerasuriyaEssential Drugs & Medicines PpolicyT: 91 11 2337 0804F: 91 11 2337 8510E-mail: [email protected]


Western Pacific

Dr. Budiono SantosoHealth Sector DevelopmentT: 632 528 9846F: 632 521 1036E-mail: [email protected]

World Health Organization, Headquarters

Mr. Lahouari BelghabriAccess to TechnologiesT: 47 241 39 25F: 41 22 791 43 84E-mail: [email protected]

Dr. Mary CouperQuality Assurance and Safety MedicinesT: 41 22 791 36 43F: 41 22 791 47 61E-mail: [email protected]


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Ms. Christine EncrenazQuality Assurance and Safety MedicinesT: 41 22 791 36 63F: 41 22 791 47 30E-mail: [email protected]

Dr. Sabine KoppQuality Assurance and Safety; MedicinesT: 41 22 791 36 36F: 41 22 791 47 30E-mail: [email protected]

Dr. Vladimir LepakhinHealth, Technology and PharmaceuticalsT: 41 22 791 44 17F: 41 22 791 48 89E-mail: [email protected]

Dr. Luc NoëlSurgery, Anesthesia aand Transplantation,Essential Health TechnologiesT: 41 22 791 36 81F: 41 22 791 48 36E-mail: [email protected]

Ms. Laura OakesQuality Assurance and Safety: MedicinesT: 41 22 791 43 44F: 41 22 791 47 30E-mail: [email protected]

Dr. Ana PadillaEssential Health TechnologiesT: 41 22 791 3892F: 41 22 791 4386E-mail: [email protected]

Dr. Lembit RägoQuality Assurance and Safety: MedicinesT: 41 22 791 44 20F: 41 22 791 47 30E-mail: [email protected]

Mr. Eshetu WondemagegnehuQuality Assurance and Safety: MedicinesT: 41 22 791 37 43F: 41 22 791 47 30E-mail: [email protected]

Mr. David WoodQuality and Safety: BiologicalsT: 41 22 791 40 50F: 41 22 791 49 71E-mail: [email protected]

Dr. Xiaorui ZhangTraditional MedicineT: 41 22 791 36 39F: 41 22 791 47 30E-mail: [email protected]

Documents

11th International Conference of Drug Regulatory Authorities