1. 1 Dr S. Kopp WHO's normative functions in the field of pharmaceuticals WHO Expert Committee on Specifications for Pharmaceutical Preparations Secretary: Dr Sabine Kopp

2. 2 Dr S. Kopp What is a WHO Expert Committee? n Official Advisory Body to Director-General of WHO n Established by World Health Assembly or Executive Board n Governed through rules and procedures n Participation in Expert Committee (EC) meetings: ä Members ("Experts") selected from WHO Expert Advisory Panels ä Technical advisers ä Observers: - international organizations, - NGOs, - professional associations…

3. 3 Dr S. Kopp WHO Expert Committees rules and procedures  WHO Basic Documents n Constitution of WHO ä Expert Committees: chapter V, article 18; chapter VIII, articles 38-40 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

4. 4 Dr S. Kopp Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) Covers today WHO’s guidance for medicines quality assurance : n Development n Production n Quality Control n Quality related regulatory guidelines n Inspection n Distribution and supply  lifecycle of medicines  from development to delivery to the patient

5. 5 Dr S. Kopp ECSPP adopts WHO guidance texts and guidelines in medicines quality assurance (without PhInt) ä Total of : ä More than 75 CURRENT official WHO guidance texts and guidelines for medicines quality assurance, including ä 8 (6 updates, 2 new published in 2014)

6. 6 Dr S. Kopp 4 th Edition of Ph.Int. including Suppl.1, 2, 3 and 4 Monographs n on pharmaceutical substances n on specific dosage forms n general on dosage forms n texts on methods of analysis n monographs on radiopharmaceuticals. and physical standards n International Chemical Reference Substances (ICRS) n

7. 7 Dr S. Kopp WHO Partners in the Expert Committee on Specifications for Pharmaceutical Preparations n National and regional authorities n International organizations (UNAIDS, UNFPA, UNICEF, World Bank, WIPO, WTO, WCO, etc) n International professional and other associations, NGOs (including consumer associations, MSF, industry: IFPMA-IGPA- WSMI, FIP, WMA, etc) n Members of the WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations

8. 8 Dr S. Kopp How to become a "WHO Expert"? n Official nomination process n Upon proposal to WHO in consultation with: l Member State/national government (citizenship)+ l WHO Regional Office (in accordance with Member State) + l WHO Headquarters n First period of 4 years n Possibility to renew

9. 9 Dr S. Kopp WHO Partners in the Expert Committee on Specifications for Pharmaceutical Preparations n Specialists from all quality assurance related areas, including regulatory, university, industry n WHO Collaborating Centres (official nomination process) – usually national quality control labs n Pharmacopoeia Commissions and Secretariats, national institutions and institutes.. n Regional and interregional groups (ICH, ASEAN, etc)

10. 10 Dr S. Kopp 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

11. 11 Dr S. Kopp When does the ECSPP start development of a guideline/guidance? 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) n Expert Committee (e.g. revision of general methods included in The International Pharmacopoeia)

12. 12 Dr S. Kopp How does the WHO Expert Committee 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

13. 13 Dr S. Kopp Additional steps for developments of specifications To cover "practical" steps, such as: n Provision of samples n Laboratory studies and scientific research for suitability of test specifications n For details full process adopted by the ECSPP  www.who.int/medicines/publications/pharmacopoeia/mono_dev

14. 14 Dr S. Kopp How does the WHO Expert Committee consultation process work? (2)  WHO Expert Committee (EC) meeting  if guideline adopted, published in EC report as Annex  If specification adopted, published in International Pharmacopoeia -> if not back to steps 2-4 (as on previous slide) n -> WHO Governing bodies n -> Recommendation to Member States and other parties for implementation

15. 15 Dr S. Kopp WHO Governing bodies … 48 th WHO Expert Committee on Specifications for Pharmaceutical Preparations – presented in May 2014

16. 16 Dr S. Kopp http://www.who.int/medicines/areas/quality_safety/q uality_assurance/en/

17. 17 Dr S. Kopp 49 th WHO Expert Committee on Specifications for Pharmaceutical Preparations (13-17 October 2014) Adopted: n Annex 1. Procedure of the development of monographs for inclusion in The International Pharmacopoeia (revision); n Annex 2. Updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia (revision); n Annex 3. Supplementary guidelines on good manufacturing practices: validation; Appendix 7: non- sterile process validation (revision);

18. 18 Dr S. Kopp 49 th WHO Expert Committee on Specifications for Pharmaceutical Preparations (13-17 October 2014) Adopted: n Annex 4. General guidance for inspectors on “hold-time” studies (new); n Annex 6. Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients (revision); n Annex 7. Guidelines on registration requirements to establish interchangeability (revision);

19. 19 Dr S. Kopp 49 th WHO Expert Committee on Specifications for Pharmaceutical Preparations (13-17 October 2014) Adopted: n Annex 8. Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products (revision); n Annex 9: Good review practices guidelines for regulatory authorities (new).

20. 20 Dr S. Kopp 49 th WHO Expert Committee on Specifications for Pharmaceutical Preparations (13-17 October 2014) Adopted: n In addition, 16 technical supplements to the WHO model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products were adopted for publication in a format which is appropriate to the large volume of this guidance (Annex 5).

21. 21 Dr S. Kopp 49 th WHO Expert Committee on Specifications for Pharmaceutical Preparations (13-17 October 2014) Adopted for inclusion in The International Pharmacopoeia: For maternal, newborn, child and adolescent health medicines: n Dexamethasone sodium phosphate (revision) n Dexamethasone phosphate injection For antiviral medicines, including antiretrovirals: n Atazanavir sulfate n Atazanavir capsules

22. 22 Dr S. Kopp 49 th WHO Expert Committee on Specifications for Pharmaceutical Preparations (13-17 October 2014) For anti-tuberculosis medicines: n Kanamycin for injection (revision) For medicines to treat tropical diseases: n Albendazole chewable tablets (revision) n Levamisole hydrochloride (revision) n Pyrantel embonate (revision) n Pyrantel chewable tablets (revision) n Pyrantel tablets (revision)

23. 23 Dr S. Kopp 49 th WHO Expert Committee on Specifications for Pharmaceutical Preparations (13-17 October 2014) For other anti-infective medicines: n Fluconazole capsules n Fluconazole injection For medicines for anaesthesia, pain and palliative care: n Dextromethorphan hydrobromide General monographs for dosage forms: n Rectal preparations (revision of the general monograph on suppositories)

24. 24 Dr S. Kopp 49 th WHO Expert Committee on Specifications for Pharmaceutical Preparations (13-17 October 2014) Analytical methods: n Disintegration test for suppositories and rectal capsules (revision of the chapter titled Disintegration test for suppositories) n Disintegration test for tablets and capsules (revision) Following the implementation of the revised general monograph on parenteral preparations the Committee adopted the proposed endotoxin limits for 11 parenteral dosage form monographs lacking such specification, together with related updates to relevant monographs.

25. 25 Dr S. Kopp 49 th WHO Expert Committee on Specifications for Pharmaceutical Preparations (13-17 October 2014) The Committee also adopted n 12 newly characterized International Chemical References Substances (ICRS) n the workplan for new monographs to be included in The International Pharmacopoeia

26. 26 Dr S. Kopp WHO Governing bodies … EB

27. 27 Dr S. Kopp

28. 28 Dr S. Kopp The International Pharmacopoeia newly available: Fourth Edition, including First, Second, Third and Fourth Supplements 2014

29. 29 Dr S. Kopp Quality Assurance of Pharmaceuticals newly available: Update 2014, including WHO guidelines, related guidance and GXP training materials

30. 30 Dr S. Kopp Thank You!