Pat O’Mahony Chief Executive Chairman Management Board EMEA · -European Risk Management Strategy Close co-operation with EMEA on development, monitoring and collation of pharmacovigilance-Working

1

Medicines Regulation in the EEA

Iceland 20th May 2008

Pat O’MahonyChief ExecutiveIrish Medicines BoardChairman Management Board EMEA

2

Agenda (1)

• The EEA regulatory system

• The challenges

• How are we meeting the challenges

• Evolution of European Regulatory Framework including:

•National agencies – IMB

• EMEA•Heads of Medicines Agencies• European Commission

3

Agenda (2)

● Impact of recent and impending Regulatory Changes

- Mutual Recognition and Decentralised Systems

- ICH Q8, Q9, Q10

● Global Situation- Summit of Competent Authorities - Need to build strong relations and strong regulatory systems

- Main Challenges over next 2 years

4

� Demographics and disease burden

� New science and new therapies

� Globalisation of the market

� Scarce resources for health budgets

� Need to improve research and development and regulatory processes

� Balance of benefit and risk

� Transparency, communication and information

The challenges for regulators and industry

5

To protect and enhance public and animal health

through the regulation of medicines, medical

devices and healthcare products.

The IMB Mission

6

IMB Functions

1. Authorisation of medicinal products for Human (H) and Veterinary (V) use

2. Inspection and licensing of manufacturers (H & V) and wholesalers (H)

3. Competent Authority for Medical Devices

4. Competent Authority for Blood Directive and for Tissues and Cells Directives

5. Approval of Clinical Trials (H) and clinical investigations (MD)

6. Pharmacovigilance/Vigilance

7. Sampling and Analysis

7

8. Enforcement (H)

9. Overseeing Recalls

10. Issue of Export Certificates (H & V)

11. Issue of GMP Certificates (H & V)

12. International representative function

13. Advice to Government

14. New areas planned including Advanced

Therapies and Cosmetics

IMB Functions

8

• Effective Risk Management and Improving Consumer Safety

• Effective Regulation through the on going Development of our Workforce and non-staff Resources

• Effective Communication with all Stakeholders

Irish Medicines Board Objectives

9

Change Programme at IMB

On going change programme to ensure that IMB is

fully capable of protecting and enhancing public and

animal health through the Regulation of medicines,

medical devices and healthcare products.

IMB must be able to participate fully in Irish,

European and Global regulatory processes.

10

European Regulatory Framework

Heads of Medicines Agencies (HMA)(1)

Mission: Heads of Member States Competent Authorities will

provide a focus for leadership within the Community System of Medicines Regulations, and provide a forum for exchange of views on issues of Community interest

11


Particular areas of focus:

- Support for Community system via high quality professional & scientific resources

- Balanced view on operation of European procedures & resource implications for Member State agencies

- Leadership for and overview of Mutual Recognition and Decentralised procedures

- Devise and deliver practical solutions to problems emerging

- Mechanism for communicating views of Competent Authorities with Commission and EMEA

12


- Meets four times per year (Presidency hosts meetings)

- Has grown in importance and focus over recent years

- Management Group and Permanent Secretariat

- Number of Working Groups

13


• Working Groups/initiatives include:- Strategy Paper

- CMD (h) & CMD (v): Facilitation Groups for Mutual Recognition and Decentralised Procedures

- Clinical Trials Facilitation Group (CTFG)

Assisting with issues arising around implementation of Clinical Trials Directive

- Benchmarking of European Medicines Agencies (BEMA)

Evaluation of harmonisation, quality systems & identification of best practices across European Agencies

14


• Working Groups/initiatives continued:

- European Risk Management Strategy

Close co-operation with EMEA on development, monitoring and collation of pharmacovigilance

- Working Group of Enforcement Officers

Building co-operation to deal with emerging threats, including counterfeits

- Task force on availability of Veterinary Medicines

Concern re non - availability of small volume niche products

- Task force on availability of Human Medicines

15

HMA Benchmarking - BEMA: an overallambitious objective for a short acronym

“To contribute to the development of a world class regulatory system for medicinal products, based on a network of agencies operating to best practice standards”

16

Responding to a European policyambition

• The Lisbon agenda

• The G10 Medicines

• The Barcelona summit

17

Strategic goal for the next decade

• Transform the region by 2010 into

the most competitive and dynamic knowledge-based economy in the world capable of achieving sustainable economic growth with more and better jobs, greater social cohesion and respect for the environment

18

Implementing a new open method of coordination

37. Implementation of the strategic goal will be facilitated by applying a new open method of co-ordination as the means of spreading best practiceand achieving greater convergence towards the main EU goals. This method, which is designed to help Member States to progressively develop their own policies, involves:

19


• Fixing guidelines for the Union combined with specific timetables for achieving the goals which they set in the short, medium and long terms;

• Where appropriate, establishing quantitative and qualitative indicators and benchmarks against the best in the worldand tailored to the needs of different Member States and sectors as a means of comparing best practice;

20

Implementing a new open method of co-ordination

• Translating these European guidelines into national and regional policies by setting specific targets and adopting measures, taking into account national and regional differences;

• Periodic monitoring, evaluation and peer review organised as mutual learning processes.

21


38. A fully decentralised approach will be applied in line with the principle of subsidiarity in which the Union, the Member States, the regional and local levels, as well as the social partners and the civil society, will be actively involved, using variable forms of partnership. A method of benchmarking best practices on managing change will be devised by the European Commission networking with different partners and users, which include the social partners, companies and NGOs.

22

Benchmarking of European medicinesagencies: the first cycle

• Initiated at the HoA/HEVRA (former HMA) meeting in Rome, November 2003

• A network of all EEA competent authorities and the EMEA

• Questionnaire (qualitative indicators)

• Self assessment

• Peer review

• Database of assessment and anonymised answers highlighting best practices

23

BEMA Questionnaire

• Questions regarding• Management of the organisation • Pre and post authorisation activities • Pharmacovigilance• Inspections and market surveillance

…avoiding overlaping with other initiatives (JAP; PICS …)

Full round completed 2006

24

BEMA 2nd cycle: the way forward

• A 3 year rolling system with annual tracking by a rolling average rating

• A self assessment and an external assessment with emphasis on evidence to support interviews and completed questionnaire

• Assessment reports focussing on strengths and areas for improvement allowing sharing of best practices

25

Sustainability of the system

• Training

• New documentation

• Setting up a network of quality managers

• Development of a secure communication facility

• Communication with interested parties to be further explored

26

BEMA - Conclusion

• BEMA, a contribution to the establishment of a European (even worlwide) reliable, sustainableand harmonised implementation of regulatoryapproach for medicines

27

European Medicines Agency (EMEA)

• Management Board

- Representatives of Patients, Medical, Veterinary, Parliament, Commission and Member States

- sets strategic direction of EMEA

- Budgeting, including apportionment of fee income between EMEA and competent authorities

• Scientific Committees and Working Parties

28

EMEA

• Road Map to 2010

- major strategy document

Aims

- better protection & promotion of public & animal health

- improve regulatory environment for medicinal products

- help stimulate innovation, R & D in EU

29

How EMEA is meeting the challenges:EMEA Road Map to 2010

� Core activities to the highest standard

� Safety of medicinal products

� Access for new medicinal products and support to innovation

� Transparency/communication and provision of information

� Strengthening the EU regulatory network

� Global cooperation

30

Support for innovation and R&D

� New procedure for scientific advice and protocol assistance introduced 1 July 2006

� New procedure for issuing of guidelines

� Small and medium size enterprises support

� Incentives (data protection)

� EMEA support to Innovative Medicine Initiative

31

Support to innovation and R&D

� EMEA task force for new technologies

• EMEA entry point for novel technologies

• EMEA website for new technologies

• Specialised CHMP working parties

� EMEA/CHMP think tank group

• To consider innovative methods of drug development and assess potential hurdles encountered by pharmaceutical industry

32

0

10

20

30

40

50

60

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 [2007] [2008]

Orphan Other (biosimilar, generic, WHO, etc) Non-orphan

Initial applications to EMEA 1995-2008

33

Average review times for positive opinions 2004 - 2006

187 203171

5694

41

31

202164 161

7 36*

0

100

200

300

400

2004 2005 2006

Days

Assessment phase EMEA post-opinion phase

Decision process Company clock-stop

34

Paediatric Paediatric

Committee Committee

(PDCO)(PDCO)

20072007

EMEA New Tasks

Committee for Committee for

Advanced Advanced

Therapies (CAT)Therapies (CAT)

20082008

35

� Advanced therapies regulation (entry into force end of 2008)

� Pharmaceutical Forum

–Patient information–Therapeutic added value–Pricing

� Communication of information to the EU-parliament

� Revision of the variation legislation� Revision of pharmacovigilance

European Commission initiatives

36


� Administrative simplification US-EU

� Reflection on the clinical trials directive

� Communication on the future of the single market of pharmaceuticals is expected in 2008

� 7th EU research framework program 2007-2010

–Medicines research

–Technology platform (IMI)

37

� The Innovative Medicine Initiative (IMI)

• Part of the 7th research framework program

• Promote development of innovative therapies

• Partners: EU Commission, academia, patients associations, EU industry (including SMEs), regulatory authorities

• Objectives: to make development process cheaper, faster, predictable.


38

International (1)

1CH Q8, Q9, Q10

• Q8 – Pharmaceutical Development

- Application of design space challenging for product development

- Evaluation challenging for assessors

- Process Analytical Technology, exciting potential for much greater process knowledge and predictable end points

39

International (2)

1CH Q8, Q9, Q10

• Q9 – Quality Risk Management

- Risk Management applied in all walks of life

- Risk minimisation / elimination even better

- Robust methods paramount

- Optional Annex 20 to GMP Guide in near future

40

International (3)

1CH Q8, Q9, Q10

• Q10 – Quality Systems

- Not yet complete

- Need for clear understanding as to how it will fit alongside existing GMPs

41

International/Global

• Pharmaceutical Inspection Cooperation Scheme (PIC/S)

- 31 Member Countries

- Number of candidates including USA

- Important for inspector training and guidance

- Blueprint for future on www.picsheme.org

42

Global (1)

- Medicinal products a global business

- Need to develop co-operation on global basis

- Ranges from formal to informal

- Builds confidence, trust

- Necessary where not possible to achieve goals unilaterally

43

Global (2)

- Summit of Competent Authorities

- Representatives from EU, Africa, North & South America, Asia, Oceania

- First meeting Washington 2006

- Second Meeting Dublin December 2007

- Exchange of views on topics of common interest/ challenges

- Development of cooperation and mutual assistance

44

- Paediatric Regulations

- Advanced Therapies Regulations

- Further Development of Pharmacovigilance / improving safety

- Clinical Trials / Good Clinical Practice

- Counterfeits, Diversion, Sub – Standard Products

- Effective implementation of ICH Q8, Q9 Q10 by those who choose

Key Challenges over the next 2 years

45

Medicines Regulation in the EEA

Iceland 20th May 2008

Thank You

Documents

Pat O’Mahony Chief Executive Chairman Management Board EMEA · -European Risk Management Strategy Close co-operation with EMEA on development, monitoring and collation of pharmacovigilance-Working