International Conference of Drug Regulatory Authorities (ICDRA)

1. International Conference of Drug Regulatory Authorities (ICDRA) Dr Lembit Rägo and Dr Sabine Kopp Quality Assurance and Safety: Medicines Medicines, Policy and Standards World Health Organization

2. Examples ofregulatory harmonization efforts and fora • Association of South-East Asian Nations (ASEAN) • Andean Community (CAN) • Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries (CADREAC) – most (10) countries involved entered EU in 2004 • European Union (EU) • Gulf Cooperation Council (GCC) • International Conference on Harmonisation (ICH) • International Conference of Drug Regulatory Authorities (ICDRA) • MERCOSUR (Southern Common Market) • Pan American Network on Drug Regulatory Harmonization (PANDRH) • Southern African Development Community (SADC) • ….

3. WHO MEDICINES STRATEGY 2004-2007 • Goal : Our vision is that people everywhere have access to the essential medicines they need; that the medicines are safe, effective, and of good quality; and that medicines are prescribed and used rationally

4. WHO Medicines Strategy: Four Objectives • POLICY – Commitment among all stakeholders to medicines policies based on the essential medicines concept, and to coordinated implementation, monitoring and evaluation of policies • ACCESS – Equitable financing, affordability and delivery of essential medicines in line with the Millennium Development Goals • QUALITY AND SAFETY – The quality, safety and efficacy of all medicines assured by strengthening and putting into practice regulatory and quality assurance standards • RATIONAL USE – Therapeutically sound and cost-effective use of medicines by health professionals and consumers

5. WHO Medicines Strategy: Seven Components POLICY: 1. Implementation and monitoring of medicines policies 2. Traditional medicine and complementary and alternative medicines ACCESS: 3. Fair financing mechanisms and affordability of essential medicines 4. Medicines supply systems QUALITY AND SAFETY: 5. Norms and standards for pharmaceuticals 6. Medicines regulation and quality assurance systems RATIONAL USE: 7. Rational use by health care professionals and consumers

6. Information exchange activities • Biennial ICDRA conference • WHO Drug Information (quarterly) • WHO Pharmaceutical Newsletter (bimonthly) • Rapid Alerts (upon need) • WHO International Drug Monitoring Program • Annual National Pharmacovigilance Centres meetings

7. ICDRA: Who? Why? What? • Unique forum for drug regulatory authorities of all WHO Member States • To strengthen collaboration • Instrumental in guiding regulatory authorities, WHO and interested stakeholders • Determine priorities for action in national and international regulation of medicines, vaccines, biomedicines and herbals

8. Objectives of the International Conference of Drug Regulatory Authorities (ICDRA) • To promote collaboration between drug regulatory authorities • To reach a consensus on matters of interest • To facilitate timely and adequate exchange of information • To discuss issues of international relevance

9. Recent challenges for Drug Regulatory Authorities • Globalisation and extension of free trade • Sophistication of products • New technologies and health care techniques • Internet (sale and information) • Counterfeit drugs • ….

10. 1996 – 2004 meetings:  http://www.who.int/medicines/icdra.shtml • 8th International Conference of Drug Regulatory Authorities (ICDRA) Bahrain, 10-13 November 1996 • 9th International Conference of Drug Regulatory Authorities (ICDRA) Berlin, 25-29 April 1999 • 10th International Conference of Drug Regulatory Authorities (ICDRA) Hong Kong, China, 24-27 June 2002  • 11th International Conference of Drug Regulatory Authorities (ICDRA) Madrid, Spain, 16-19 February 2004

11. ICDRA: Participants, some figures 9th ICDRA (Berlin): • more than 280 participants from 90 Member States 10th ICDRA (Hongkong): • from 100 Member States 11th ICDRA (Madrid) : • from 110 Member States, and regional regulatory authorities and pharmacopoeias

14. Eleventh International Conference of Drug Regulatory Authorities (ICDRA) 16 - 19 February 2004 Madrid, Spain Progress Report on Tenth ICDRA Dr Vladimir K. Lepakhin Assistant Director-General Health Technology and Pharmaceuticals World Health Organization, Geneva

15. ICDRA recommendations WHO should ... WHO action taken Access to drugs and vaccines • In collaboration with Member States, focus on good trade and distribution practices of starting materials to ensure use of high quality materials • The WHO Expert Committee on Specifications for Pharmaceutical Preparations adopted: (1) Good Trade and Distribution Practices (GTDP); and (2) WHO Pharmaceutical Starting Materials Certification Scheme (SMACS) • Both received approval from the WHO Executive Board in January 2004

16. ICDRA recommendations WHO should ... WHO action taken Safetyof Blood Derived Products • Promote the regulation of blood and plasma collection centres, ensuring GMP compliance - regional cooperation - training • A GMP programme applied to blood and plasma collection centres will be initiated in June 2004. First workshop will be held in Argentina, in collaboration with the Region for the Americas • Training activities are targeted at national regulatory authorities and blood transfusion services

17. Monitor developments and continue to provide clear guidelines on issues related to the quality, safety and efficacy of biotechnology-derived medicinal products, including biocomparability Consultations convened since the ICDRA (a) WHO Monitoring Group on gene transfer medicinal products (May 2003); and (b) Characterization and Quality Aspects of Vaccines based on Live Viral Vectors (December 2003) ICDRA recommendations WHO should ... WHO action taken Regulating Biotechnology Products • Continue to develop international biological reference materials that can serve as reference standards for new products • WHO has established 29 new or replacement international biological reference materials in the past two years

18. ICDRA recommendations WHO should ... WHO action taken Regulatory challenges: Health Sector Reform and Drug Regulatory Capacity • Study existing experience and undertake research in order to develop models for intensified collaboration and, where appropriate, joint decision-making among national regulatory authorities • The EMEA model for joint decision-making is being tested in regional and subregional networks of regulatory authorities • Further support national authorities to introduce or improve data management systems in order to produce and interchange information and to achieve evidence-based decision-making. • Model information management system developed in collaboration with EMEA being promoted as a model for other countries to use as reference in all WHO regions

19. Strengthen the existing anti-counterfeit liaison officers to promote exchange of information on counterfeit drugs amongst and between regulatory authorities and WHO WHO’s web site counterfeit pages have been updated, made user-friendly and the content revised and updated ICDRA recommendations WHO should ... WHO action taken Counterfeitdrugs • Tools for CFT reporting have been revised and can now be downloaded

20. E-commerce ICDRA recommendations WHO should ... WHO action taken • Establish and maintain a list of national focal points and circulate it to all regulatory authorities in order to foster international collaboration in combating illegal pharmaceutical e-commerce • List of national focal points created. International collaboration encouraged through ad hoc messages at international symposia

21. Sessions in 11th ICDRA (1) • Pharmacopoeias in a changing regulatory environment • Regulatory assessment of combination products • Regulators, GCP and Ethics • Public health needs vs the marketplace • Regulatory aspects of access to medicines • Safety of herbal medicines • Assuring quality and safety of blood products

22. Sessions in 11th ICDRA (2) • Strengthening of regulatory frameworks for medicinal products • Human tissue: problems and challenges for regulators • Regulatory tools for providing drug information • Harmonization updates • Promoting good regulatory practices … • Recommendations in: • WHO Drug Information Vol 18, No. 1, 2004 • Full report of 11th ICDRA with all presentations on CD available and on web

23. Pharmacopoeias in a changing regulatory environment (recommendations) • Member States to encourage close collaboration between regulatory authorities and pharmacopoeial secretariats/commissions • WHO should organize an international conference on pharmacopoeial issues in collaboration with parties concerned • WHO to develop a harmonized approach to providing internationally validated specifications for medicines for neglected and emerging diseases of high public health risk • Seven ARVs' adopted in 2004 for inclusion in Int.Ph. (didanosine, - indinavir sulfate, - nelfinavir mesilate, - nevirapine, - ritonavir, - saquinavir, - saquinavir mesilate)

24. Pharmacopoeias in a changing regulatory environment (recommendations –continued-) • WHO to continue to support the establishment of international chemical reference substances (ICRS)  ICRS newly available for antimalarials agents artemisinin derivatives  ICRS for antiretrovirals underway

25. Regulatory assessment of combination products (recommendations) • Regulators to critically review the existing fixed dose combination drugs on the market and withdraw those which do not meet these requirements • WHO is urged to create — as a matter of urgency — model guidelines for regulatory approval of prescription-only fixed dose combination drugs with emphasis on drugs for communicable diseases with high public health impact  Newly adopted WHO guideline on FDCs (39th WHO Expert Committee, Annex 5, in preparation)

26. Regulators, Good Clinical Practice and Ethics (recommendations) • Member States to implement GCP in all clinical research and to ensure that informed consent processes meet all GCP, national and ethical requirements. • WHO Handbook on GCP implementation drafted (to be finalized in 2005) • Guidance material on how to ensure the quality of BE studies carried out by CROs drafted (to be finalized in 2005) • Member States to recognize that gene therapy is a new complex area of medicine needing rigorously implemented GCP and ethical oversight

27. Regulators, Good Clinical Practice and Ethics (recommendations) • WHO to gather and to share with Member States existing knowledge and experience of safety, efficacy and quality of innovative biotechnology products • WHO to accelerate its work in regulatory capacity building for assessment of vaccines and medicines of public health importance • A number of specified workshops for regulators organizedby WHO in 2004 and 2005

28. Some more 11th ICDRA recommendations • Regulators have role and responsibility to facilitate access to drugs of public health importance to facilitate access without compromising on quality, safety and efficacy. • guidelines on registration requirements to establish interchangeability of multisource (generic) pharmaceutical products (revision in progress), discussion on biowaivers and international comparators list •  good distribution practices (GDP) for pharmaceutical products (in progress) • -> harmonization efforts regarding stability testing

29. Some more 11th ICDRA recommendations • Member States to strengthen efforts to increase transparency of drug regulatory authorities. • WHO to continue pre-qualification of drugs for priority disease programmes, particularly HIV, malaria and TB. • Transparency of prequalification increased with WHO Public Assessment (WHOPARs) and Inspection Reports (WHOPIRs) going to web – good example to follow for MS?

30. 12th ICDRA When? Spring 2006 Where? Seoul, Republic of Korea Program? Planning meeting in Geneva April 2005 Suggestions for topics to be discussed welcome: Dr Lembit Rägo (ragol@who.int)

31. Thank you! !Muchas gracias! http://www.who.int/medicines/