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

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. What WHO is doing? 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

10. Conclusions A lot of good work ongoing but ….
Limited capacity to advertise, promote, inform etc.
Limited resources to build capacity in countries
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