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Safe quality medicines

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. Main points addressed. Who is WHO? How does WHO set standards?

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Safe quality medicines

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  1. Safe quality medicines

  2. 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. Main points addressed • Who is WHO? • How does WHO set standards? • Which WHO guidelines, standards and norms exist in the area of quality assurance? • What's new ?

  4. Who is WHO? Governing bodies • World Health Assembly (WHA) Delegations from 194 Member States Meeting yearly in May • Executive Board(EB) Representatives from 34 Member States + Meeting biannually in January and May

  5. Impressions from World Health Assembly • - SSFFC

  6. WHO is WHO ?Secretariat and Experts • WHO Secretariat: - Headquarters - six Regional Offices and 149 Country offices • Experts: - WHO Expert Panels and Expert Committees - WHO Collaborating Centres - + partners • Constitution signed 1946, in force since 7 April 1948 (World Health Day)

  7. WHO Governing bodies …

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

  9. WHO Expert Committees rules and procedures  WHO Basic Documents • Constitution of WHO • Expert Committees: chapter V, article 18; chapter VIII, articles 38-40 • 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;" • Regulations for Expert Advisory Panels and Committees, including, Annex – Rules of Procedure for Expert Committees

  10. Examples of WHO Expert Committees ? • WHO Expert Committee on Specifications for Pharmaceutical Preparations • WHO Expert Committee on the Selection and Use of Essential Medicines • WHO Expert Committee on Drug Dependence • WHO Expert Committee on Biological Standardization • Joint FAO/WHO Expert Committee on Food Additives • ….

  11. Outcome of the WHO Expert Committee? • 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 •  constitutes WHO technical guidance

  12. When does the WHO Expert Committee start development of a guideline/guidance? • Based on recommendations by : • World Health Assembly resolutions(e.g. WHA 20.34, GMP - Good manufacturing practices) • Executive Board resolutions(e.g. EB37.R9 delegating certain functions of INN Programme to DG based on advice from Experts) • International Conference of Drug Regulatory Authorities(e.g. 10th +11th ICDRA – FDC guidelines + Certification Scheme for pharmaceutical starting materials moving into international commerce) • 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) • Expert Committee (e.g. revision of general methods included in The International Pharmacopoeia)

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

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

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

  16. WHO Partners (3) With "recognized" Experts… • WHO Expert Panel on The International Pharmacopoeia and Pharmaceutical Preparations (official nomination process) • Specialists from all areasfor specific projects (regulatory, university, industry…) With "recognized" Laboratories… • National/Regional Quality control laboratories • WHO Collaborating Centres (official nomination process)

  17. Medicines Quality Assurance in WHO Historical overview • 1st "WHO Expert Committee on Specifications for Pharmaceutical Preparations" ( ECSPP) meeting held 13-17 October 1947 • Report of 1st ECSPP meeting published in: • Official Records of WHO, No 8, page 54ff, 1947

  18. WHO’s medicines quality assurance guidelines Cover: • Development • Production • Quality Control • Quality related regulatory guidelines • Inspection • Distribution •  from manufacture (and before) to delivery to patient

  19. Adopted WHO guidance texts and guidelinesin medicines quality assurance (without PhInt) Maintain to keep up to date: • More than 60 CURRENT official WHO guidance texts and guidelines to date; • 8 updates + 7 new adopted 2010; • 2 updates + 4 new adopted 2011; • 2 updates + 2 new adopted 2012.

  20. Quality Control http://www.who.int/medicines/areas/quality_safety/quality_assurance/control/ 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. International PharmacopoeiaPh.Int. • current: 4th 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. Distribution http://www.who.int/medicines/areas/quality_safety/quality_assurance/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. Production • http://www.who.int/medicines/areas/quality_safety/quality_assurance/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. Quality related regulatory standards http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/ Some 20 guidance documents and guidelines, including : • Stability testing requirements • Interchangeability of generic medicines • Fixed-dose combination • All prequalification procedures

  25. 47th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome - 1- 1. 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. 47th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome -2- 2. Adopted global quality assurance guidelines: • New guidance on quality risk management (QRM) • Guidance on variations to a prequalified product (revision) • Collaborative procedure between WHO PQ and NMRAs in the assessment and accelerated registration of national WHO-prequalified pharmaceutical products

  27. 46th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome -3- • Quality requirements of artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients

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

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

  30. WHO Medicines Quality Assurance website:http://www.who.int/medicines/areas/quality_safety/quality_assurance

  31. Safe quality medicines

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