1. 1 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals WHO’s Role in Assuring the Quality Safety and Efficacy of Medicines: Introduction Lembit Rägo, MD, PhD Coordinator, Quality Assurance and Safety: Medicines (QSM) Acting Coordinator, Quality Assurance and Safety: Blood Products and Related Biologicals (QSD) Essential Drugs and Medicines Policy Health Technology and Pharmaceuticals Cluster World Health Organization E-mail: ragol@who.ch EDM Technical Briefing 2006

2. 2 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals This block of presentations gives n General introduction to quality and safety issues n Detailed overview of WHO's normative activities in the area of medicines (excluding biologicals) quality (QSM) n Introductory presentation on the area of quality assurance and safety of blood products and related biologicals (QSD)

3. 3 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals The rest of the QSM activities n Later in the programme ä Prequalification ä Safety - Pharmacovigilance n Not covered by this training course ä INN programme ä ATC/DDD classification and its use ä Scheduling controlled substances and access to controlled medicines ä …

4. 4 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals Standards for medicines n How to judge that medicines are what we expect them to be? n In case of many products people take their judgements at least partly based on what they see, smell or taste …or hear

5. 5 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals Usual perceptions may not help to make judgments about medicines … SmellAppearance Taste

6. 6 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals In case of medicines they all look nice, mostly do not have any smell, some may have bad taste…and are increasingly marketed even through internet (see example below, note that selling medicines via internet may be illegal and products may be counterfeit or substandard)

7. 7 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals Why medicines are special category of products? n Consumers, patients and health care workers have limited capacity to judge there ä SAFETY ä QUALITY ä EFFICACY

8. 8 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals Are all medicines safe, effective and meet quality criteria? n No, they are not n Some are safe, but not effective or necessarily meet the quality criteria n Some may be effective, meet quality criteria but are not safe n Some meet quality criteria but are not necessarily safe or have any efficacy

9. 9 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals Quality - Safety n Some safety parameters are determined by quality n Some safety parameters are determined by the intrinsic properties of active pharmaceutical ingredient ä However, in fact QUALITY in general perception (and often in policy documents) is incorporating also expectations for efficacy and safety without necessarily saying so

10. 10 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals What type of medicines we have? n Originator products n Multisource (generic) products ä KEY – INTERCHANGEABILITY, more important THERAPEUTIC INTERCHNGEABILITY ä ALL LITERATURE IS BASED ON ORGINATORS ä No interchangeability – NEED FOR NEW SAFETY and EFFICACY DATA, NEW BOOKS HAVE TO BE WRITTEN

11. 11 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals What type of regulations exist and how they differ? n For innovator products proof of QUALITY, SAFETY and EFFICACY is needed n 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)

12. 12 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals Regulations: Global vs National n National regulations still differ a lot n What is ICH and what it is not? n Regional harmonization initiatives n Do global norms exist for generics?

13. 13 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals Who sets the standards? Is the WHO Involved? n WHO has the unique mandate to set standards n WHO Constitution (Chapter II, Article 2), inter alia, states (6): ä In order to achieve its objective, the functions of the organization shall be: … to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products; Example of WHO work from 1966

14. 14 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals Is quality of medicines a problem? n Yes, a HUGE problem n If we would have the same compliance with norms and quality in aircraft industry Globally as we have with medicines, perhaps n ä approximately 25% planes would not take off the grounds (no or very poor treatment effect, can also potentially kill if disease deadly) ä 5-10% would crash and injure or kill the people (toxicity, severe adverse reactions etc. )

15. 15 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals What WHO is doing? n Norms and standards, nomenclatures ä International Pharmacopoeia ä International Nonproprietary Names (INN) ä ATC/DDD classification ä … n Regulatory guidelines ä Good Manufacturing Practice; Good Clinical Practice etc. ä Comprehensive set of guidelines for registering generic drugs ä … n Information exchange ä WHO Drug Information (quarterly) ä WHO pharmaceutical Newsletter ä WHO Rapid Alerts ä International Conference of Drug Regulatory Authorities (ICDRA) – usually more than 100 countries represented ä …. n Capacity building and training ä GMP training courses ä Courses on how to assess generic drugs ä Courses on pharmacovigilance ä ….

16. 16 Department of Medicines Policy and Standards, Health Technology and Pharmaceuticals Conclusions n A lot of good work ongoing but …. ä Limited capacity to advertise, promote, inform etc. ä Limited resources to build capacity in countries n Please, for more information: l http://www.who.int/medicines