Update and future directions for prequalification of medicines

WHO HQ, Geneva, 4 February 2008

Dr Lembit RägoCoordinatorQuality Assurance and Safety: MedicinesMedicines Policy and StandardsHealth Systems and Services

Prequalification of medicines

Established in 2001 Started with HIV/AIDS products, later TB, malaria and

selected reproductive health products were added Based on WHO normative guidelines, widely discussed

and transparent Open to both innovative and generic medicines Carried out by global pool of regulators for the benefit of

all stake holders – outcome list of prequalified products as a public good

Capacity building and training important component Continues to face old, but also meets new challenges

Which medicines and why PQ Programme deals with?

Application to include a product on Expression of Interest (EOI) Lists published comes from WHO disease oriented programs

Products should be of high public health value Products must be in line with WHO treatment

guidelines Products must be in line with Essential Medicines

List Rare exceptions from these principles, if justified

Constantly updated web site: http://www.who.int/prequal/

Highlights of 2007

Total number of prequalified products reached 156 Increased work load for maintenance Relatively small number of new products prequalified "New comers" – usually low quality submissions Applicants "fatigue" – not enough new products

applied Boosting quality control laboratories prequalification Strengthening programme, increasing transparency Substantially increased delivery of trainings and

technical assistance (+100% increase)

Trainings

News example

HIV/AIDS

In total 360 assessment reports were written in 2007

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TB products

In total 87 assessment reports were written in 2007

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Reports

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Inspections – finished product manufacturers

Inspections of finished products manufacturers increased during 2007 reaching 26

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Inspections

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2007

Submission of product dossiers

2005 20062007

HIV 67 42 23TB 17 9 17Malaria 3 5 6

NO NEW SUBMISSIONS in 2007 of some priority products:- 2nd-line anti-tuberculosis products - paediatric anti-retroviral products

Proactive steps in 2007 – 2nd-line TB

Scientific advice on design appropriate of bio-equivalence studies

Detailed guidance to perform dissolution studies to implement biowaiver (to replace BE-study, if feasible)

Development of Pharmacopoeia monographs for anti-tuberculosis medicines

Situation (gap) analysis on the potential of tb-manufacturers to develop new products

Proactive steps in 2007 – Malaria

Proactive working with applicants (pre-submission review, reminders, coordinate submission of additional data, meetings for solving problems)

Scientific advice on design appropriate of bio-equivalence studies

Research (adverse reactions database, complicated quality issues)

Development of Pharmacopoeia monographs for antimalarial medicines

Proactive steps in 2007– paediatric medicines

To support appropriate dosage and formulation design by manufacturers: First Essential Medicines List for Children WHO guidance on preferred ARV medicines for

the children; model to design proper strengths of fixed-dose combination products for different weight/age

Consultation with other regulators (such as US FDA)

Two training courses on "Development of Paediatric Medicines" in 2007, third prepared for India in April 2008

To ensure sustainability of supplies of good quality priority products: challenges

Continue developing WHO standards and guidelines Guidance on development and analytical control of

TB and antimalarial medicines Close the information gap for paediatric medicines Implement comprehensive sampling and testing

programme Develop a comprehensive programme for providing

technical assistance to potential new manufacturers If manufacturers are to be persuaded to make the

human and technological investments needed to enhance quality of medicines, financial incentives must be built into procurement mechanisms.

Future directions: short-term

Technical guidance, regulatory advise and technical assistance to manufacturers has to increase

Increasing efficiency: shorter timelines, pro-active follow-up and communication for priority products

Continuing human resource development – new assessors/inspectors identified and trained Trainings organized for assessors to achieve better

consistency and the same level of technical skills Continuing developing capacity building element in the

programme Second rotational post to be considered

Increased communication and information exchange with regulators (both from well resourced and less resourced countries)

Future directions: long-term

Long-term strategy to be finalized during 2008 Promoting and facilitating production of quality

medicines in developing countries continued Structured co-operation with regulatory agencies

further developed to avoid duplications using several tools Memorandums of understanding, confidentiality

agreements Collaboration agreements

Promoting harmonization continued - potential to work with some regional harmonization initiatives to be explored

Exploring potential of contracting certain functions to national regulators/quality control laboratories

Instead of conclusions

Prequalification - a good engine to pull quality of medicines into international agenda

It challenges the still existing reality "poor quality medicines for poor"

How best keep it going as huge unfinished agenda is ahead?