WHO’s Role in Assuring the Quality Safety and Efficacy of Drugs: Introduction

1. WHO’s Role in Assuring the Quality Safety and Efficacy of Drugs: Introduction EDM Technical Briefing 2004 Lembit Rägo, MD, PhD, Coordinator Quality Assurance and Safety: Medicines Essential Drugs and Medicines Policy Health Technology and Pharmaceuticals Cluster World Health Organization E-mail: ragol@who.ch

2. Why medicines are special category of products? • Consumers, patients and health care workers have limited capacity to judge there • SAFETY • QUALITY • EFFICACY

3. Are all medicines safe, effective and meet quality criteria? • No, they are not • Some are safe, but not effective or necessarily meet the quality criteria • Some may be effective, meet quality criteria but are not safe • Some meet quality criteria but are not necessarily safe or have any efficacy

4. Quality - Safety • Some safety parameters are determined by quality • Some safety parameters are determined by the intrinsic properties of active pharmaceutical ingredient

5. What type of medicines we have? • Originator products • Multisource (generic) products • KEY – INTERCHANGEABILITY, more important THERAPEUTIC INTERCHNGEABILITY • ALL LITERATURE IS BASED ON ORGINATORS • No interchangeability – NEED FOR NEW SAFETY and EFFICACY DATA, NEW BOOKS HAVE TO BE WRITTEN

6. What type of regulations exist and how they differ? • For innovator products proof of QUALITY, SAFETY and EFFICACY is needed • For multisource products QUALITY, safety and efficacy data is referred to the originator providing only evidence about interchangeability (bioequivalence, clinical testing, in limited cases dissolution data)

7. Regulations: Global vs National • National regulations still differ a lot • What is ICH and what it is not? • Regional harmonization initiatives • Do global norms exist for generics?

8. Is quality of medicines a problem? • Yes, a HUGE problem • If we would have the same compliance with norms and quality in aircraft industry Globally • approximately 25% planes would not take off the grounds • 10% would crash and kill the people (treatment failure = killing in some cases; toxicity etc. )

9. Norms and standards, nomenclatures International Pharmacopoeia International Nonproprietary Names (INN) ATC/DDD classification … Regulatory guidelines Good Manufacturing Practice; Good Clinical Practice etc. Comprehensive set of guidelines for registering generic drugs … Information exchange WHO Drug Information (quarterly) WHO pharmaceutical Newsletter WHO Rapid Alerts International Conference of Drug Regulatory Authorities (ICDRA) – usually more than 100 countries represented …. Capacity building and training GMP training courses Courses on how to assess generic drugs Courses on pharmacovigilance …. What WHO is doing?

10. Conclusions • A lot of good work ongoing but …. • Limited capacity to advertise, promote, inform etc. • Limited resources to build capacity in countries • Please, for more information: • http://www.who.int/medicines