1 Technical Briefing Seminar | 1 November 2012 Safe quality medicines

Medicines quality assurance: WHO's normative functions in the field of pharmaceuticals Sabine Kopp, PhD Quality Assurance and Safety: Medicines Department of Essential Medicines and Health Products

3 Technical Briefing Seminar | 1 November 2012 Main points addressed n Who is WHO? n How does WHO set standards? n Which WHO guidelines, standards and norms exist in the area of quality assurance? n What's new ?

4 Technical Briefing Seminar | 1 November 2012 Who is WHO? Governing bodies n World Health Assembly (WHA) Delegations from 194 Member States Meeting yearly in May n Executive Board (EB) Representatives from 34 Member States + Meeting biannually in January and May

5 Technical Briefing Seminar | 1 November 2012 Impressions from World Health Assembly n - SSFFC

6 Technical Briefing Seminar | 1 November 2012 WHO is WHO ? Secretariat and Experts n WHO Secretariat: - Headquarters - six Regional Offices and 149 Country offices n Experts: - WHO Expert Panels and Expert Committees - WHO Collaborating Centres - + partners n Constitution signed 1946, in force since 7 April 1948 (World Health Day)

7 Technical Briefing Seminar | 1 November 2012 WHO Governing bodies …

8 Technical Briefing Seminar | 1 November 2012 What is the WHO Expert Committee? n Official Advisory Body to Director-General of WHO n Governed though rules and procedures (Ref. WHO Manual) n Participation in Expert Committee (EC) meetings: ä Members ("Expert") selected from WHO Panel of Experts ä Technical advisers ä Observers: - international organizations, - NGOs, - professional associations…

9 Technical Briefing Seminar | 1 November 2012 WHO Expert Committees rules and procedures WHO Basic Documents n Constitution of WHO ä Expert Committees: chapter V, article 18; chapter VIII, articles ä For normative function - pharmaceuticals: Chapter 2, article 2 (u): " to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products;" n Regulations for Expert Advisory Panels and Committees, including, Annex – Rules of Procedure for Expert Committees

10 Technical Briefing Seminar | 1 November 2012 Examples of WHO Expert Committees ? n WHO Expert Committee on Specifications for Pharmaceutical Preparations n WHO Expert Committee on the Selection and Use of Essential Medicines n WHO Expert Committee on Drug Dependence n WHO Expert Committee on Biological Standardization n Joint FAO/WHO Expert Committee on Food Additives n ….

11 Technical Briefing Seminar | 1 November 2012 Outcome of the WHO Expert Committee? n Report of the WHO Expert Committee: - Summarizes discussion - Gives recommendations to WHO + Member States - Includes newly adopted guidelines; - Is presented to WHO Governing Bodies for final comments, endorsement and implementation by Member States n constitutes WHO technical guidance

12 Technical Briefing Seminar | 1 November 2012 When does the WHO Expert Committee start development of a guideline/guidance? n Based on recommendations by : n World Health Assembly resolutions (e.g. WHA 20.34, GMP - Good manufacturing practices) n Executive Board resolutions (e.g. EB37.R9 delegating certain functions of INN Programme to DG based on advice from Experts) n International Conference of Drug Regulatory Authorities (e.g. 10 th +11 th ICDRA – FDC guidelines + Certification Scheme for pharmaceutical starting materials moving into international commerce) n Other WHO programmes and clusters (e.g. necessity for quality control specifications for specific medicines of major public health interest and feedback from Prequlifcation programme) n Expert Committee (e.g. revision of general methods included in The International Pharmacopoeia)

13 Technical Briefing Seminar | 1 November 2012 How does the WHO consultation process work? n Step 1. Preliminary consultation and drafting n Step 2. Draft guidelines n Step 3. Circulation for comments n Step 4. Revision process n (back to step 2 and 3 as often as needed) n WHO Expert Committee (EC) meeting ä if guideline adopted, published in EC report as Annex n -> WHO Governing bodies n -> Recommendation to Member States for implementation

14 Technical Briefing Seminar | 1 November 2012 WHO Partners With Regulatory Bodies… n National/Regional regulatory authorities n Regional/Interregional regulatory groups (ASEAN, GCC, ICH, PANDRH...) Within WHO… n WHO disease programmes (Stop TB, Roll-Back Malaria, HIV/AIDS, Tropical Neglected Diseases, programmes on Children, Women's Health… ) n Prequalification Programme – A United Nations Programme managed by WHO

15 Technical Briefing Seminar | 1 November 2012 WHO Partners (2) With Organizations and Associations… n International organizations (UNAIDS, UNICEF, IAEA, Global Fund, World Bank…) n International professional and other associations, NGOs (incl. industry, consumer associations: IFPMA, IGPA, WSMI, IPEC, FIP, WMA, MSF…) With Standard-setting Bodies, such as … n Pharmacopoeia Commissions and Secretariats (e.g. British Brazilian, Chinese, European, Indian, Korean, Japanese, USP,.. )

16 Technical Briefing Seminar | 1 November 2012 WHO Partners (3) With "recognized" Experts… n WHO Expert Panel on The International Pharmacopoeia and Pharmaceutical Preparations (official nomination process) n Specialists from all areas for specific projects (regulatory, university, industry…) With "recognized" Laboratories… n National/Regional Quality control laboratories n WHO Collaborating Centres (official nomination process)

17 Technical Briefing Seminar | 1 November 2012 Medicines Quality Assurance in WHO Historical overview 1st "WHO Expert Committee on Specifications for Pharmaceutical Preparations" ( ECSPP) meeting held October 1947 Report of 1st ECSPP meeting published in: Official Records of WHO, No 8, page 54ff, 1947

18 Technical Briefing Seminar | 1 November 2012 WHOs medicines quality assurance guidelines Cover: n Development n Production n Quality Control n Quality related regulatory guidelines n Inspection n Distribution n from manufacture (and before) to delivery to patient

19 Technical Briefing Seminar | 1 November 2012 Adopted WHO guidance texts and guidelines in medicines quality assurance (without PhInt) Maintain to keep up to date: ä More than 60 CURRENT official WHO guidance texts and guidelines to date; ä 8 updates + 7 new adopted 2010; ä 2 updates + 4 new adopted 2011; ä 2 updates + 2 new adopted 2012.

20 Technical Briefing Seminar | 1 November 2012 Quality Control ol/ More than 10 guidance documents and guidelines, including - Good laboratory practices + training materials - Guidelines for establishment of chemical reference standards - Model certificate of analysis - International Pharmacopoeia + Basic tests

21 Technical Briefing Seminar | 1 November 2012 International Pharmacopoeia Ph.Int. current: 4 th edition! Supplement 1 +2 implementation: ready for use by Member States Scope since 1975: Model List of Essential Medicines and Drugs recommended by WHO Specific disease programmes, e.g. Malaria, TB, HIV/AIDS, medicines for children

22 Technical Briefing Seminar | 1 November 2012 Distribution urance/distribution Some 10 guidance documents and guidelines, e.g.: - Certification schemes (CPP and SMACS) - Quality system for Procurement - Good distribution practices for starting materials and finished products - Good storage practices

23 Technical Briefing Seminar | 1 November 2012 Production Some 20 guidance documents and guidelines, including: - Good Manufacturing Practices (GMP) …..Consisting of more than 10 major "guideline" texts (regularly updated, new texts added as needs are identified) - ….. Training materials (slides, video, GMP text) - Risk analysis (HACCP) – moving to "quality risk management"

24 Technical Briefing Seminar | 1 November 2012 Quality related regulatory standards gulatory_standards/ Some 20 guidance documents and guidelines, including : - Stability testing requirements - Interchangeability of generic medicines - Fixed-dose combination - All prequalification procedures

25 Technical Briefing Seminar | 1 November th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome Adopted texts: The International Pharmacopoeia Monographs for the following: - Medicines for HIV and related conditions - Antimalarial medicines - Antituberculosis medicines - Anti-infectives Harmonized general texts (based on PDG texts) -

26 Technical Briefing Seminar | 1 November th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome Adopted global quality assurance guidelines: ä New guidance on quality risk management (QRM) ä Guidance on variations to a prequalified product (revision) ä Collaborative procedure between WHO PQ and NMRAs in the assessment and accelerated registration of national WHO-prequalified pharmaceutical products

27 Technical Briefing Seminar | 1 November th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome -3- ä Quality requirements of artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients

28 Technical Briefing Seminar | 1 November 2012 Advantages of WHO's Expert Committee standard-setting process n 1. Guidelines and specifications validated internationally, through an independent scientific process, adoption by members of WHO Expert Advisory Panels n 2. Collaboration with standard-setting organizations and parties, including regional and national pharmacopoeias n 3. Networking and close collaboration with WHO Member States, Drug Regulatory Authorities, national medicines quality control laboratories

29 Technical Briefing Seminar | 1 November 2012 Advantages of WHO's Expert Committee standard-setting process (2) n 4. Links with other WHO activities n 5. Reality check: Input from manufacturers (including international associations of research, generic and self-medication associations) around the world n 6. Consideration of costs, e.g. keeping need for reference standards at a minimum n 7. Service FREE FOR USE by all Member States

30 Technical Briefing Seminar | 1 November 2012 WHO Medicines Quality Assurance website:

31 Technical Briefing Seminar | 1 November 2012 Safe quality medicines