Trainings and capacity building activities in WHO Prequalification Programme

1. Trainings and capacity building activities in WHO Prequalification Programme Milan Smid Quality Assurance and Safety: Medicines (QSM) Essential Medicines and Policy (EMP)

2. WHO Medicines Prequalification Programme • To increase access to priority medicinal products of acceptable unified standards • Prequalification of medicinal products (PQ) • Evaluation of quality, safety and efficacy based on submitted data • Inspections of manufacturers and clinical testing sites • Listing and follow-up of prequalified medicinal products • Variations, Inspections, Sampling and testing, Requalification • Prequalification of Quality Control Laboratories • Inspections and evaluations • Capacity building

3. Capacity building • WHO support to the generation of expertise for development, manufacture, control or regulation of medicines Manufacturers Clinical Research Organizations (CROs) Quality control laboratories (QCLs) National Regulatory Authorities (NRAs)

4. Capacity building • Stimulation to submit for WHO prequalification • Instructions how to produce medicines according to standards of WHO good manufacturing practice • Instructions how to submit dossier for WHO prequalification in compliance with formal and technical standards and how to maintain it • Instructions how regulators may benefit from prequalification and worksharing • Support to strengthening of regulatory systems • Stimulation to prequalify quality control laboratories • Instructions how to prequalify quality control laboratories and be in compliance with good laboratory practice in control laboratory • Instructions about sources of relevant information

5. Capacity building 1) Trainings 2) Technical assistance 3) Provision of information, standards and regulatory expertise

6. Capacity building Prequalification Programme in itself is indirectly a capacity building process due to: • Possibility to learn from GMP and GCP inspections • Possibility to learn from deficiency letters • Possibility to learn from public reports

7. 1a) Collective trainings • Seminars and workshops • General – PQ procedures and WHO requirements • Problem oriented • HIV/AIDS, TB, antimalarial or RH products • Pharmaceutical development/paediatric dosage forms, BE/BCS • Trainings of NRA staff and manufacturers frequently combined • Third parties frequently involved • Support is given to trainings organized by others • Focus on "training of trainers" • WHO training materials used, when available (GMP, GPCL))

9. Main partners in organization of trainings in 2007/2009 • International Pharmaceutical Federation (FIP) • European Directorate for the Quality of Medicines & Healthcare (EDQM) • National Regulatory Authorities in South Africa, Tanzania, Estonia, Ukraine, Morocco, Brazil, Jordan, Ghana, Egypt, Indonesia, Kenya, Uganda, China • National Quality Control Laboratories in Morocco and Tanzania • East Africa Community (EAC) • Association of Southeast Asian Nations (ASEAN) • Ministry of Health China, Pakistan, Iran, Morocco • Program for Appropriate Technology in Health (PATH) • United Nations Population Fund (UNFPA) • European Medicines Agency (EMEA) • Drug Information Association (DIA) • Therapeutic Goods Agency Australia (TGA) • Roche Pharmaceuticals

10. Basic training modules • Principles of WHO prequalification of medicines • Good manufacturing practice • Requirements on quality of medicines • Development of pharmaceutical formulation • Bioequivalence / biopharmaceutical classification system • Principles of WHO prequalification of quality control laboratories and GLPQC May be adapted to specific therapeutic categories of medicines

11. Topics of workshops in 2006-2009 (I-IX)

12. Focus on specific medicines

13. Trainings organized or supported byEMP/QSM in 2009 (I-XI) (1) • Assessment of pharmaceutical quality in PQP • Copenhagen, Denmark, January 14-16, 2009 • WHO Prequalification programme and requirements • Damascus, Syria, February 8-9, 2009 • WHO Prequalification programme and requirements • Cairo, Egypt, February 11-12, 2009 • Training workshop on ACTs • Kampala, Uganda, February 23-27, 2009 • Training workshop on the Assessment of Multisource Interchangeable Medicines • Mombasa, Kenya, July 10-14, 2009 • Interregional seminar for Quality Control Laboratories • Nairobi, Kenya, September 23-25, 2009 • Quality of Active Pharmaceutical Ingredients • Hyderabad, India, September 5-7, 2009

14. Trainings organized or supported byEMP/QSM in 2009 (I-XI) (2) • Advanced workshop on WHO prequalification of reproductive health products • Jakarta, Indonesia, October 5-8, 2009 • Assessment of bioequivalence data submitted to regulatory authorities • Kiev, Ukraine, October 26-30, 2009. • Manufacture of sterile medicines for SFDA GMP inspectors • Nanjing, China, November 16-20, 2009

16. Countries where prequalified medicines are manufactured (July 2009)

18. 1b) Individualized trainings • Involvement of assessors from NRAs in PQ assessment • Involvement of inspectors from NRAs in PQ inspections • Rotations of experts from NRAs in WHO HQ • 3 months working experience inside PQ team • Personal development of experts from NRAs and strengthening of PQ Programme by new capacities • Development of focal persons with understanding and confidence to WHO PQ for prequalification networking and products follow-up • Development of new trainers • Motivation of trainees and NRAs to improvement of regulatory practices and future co-operation

19. 2) Technical Assistance • Provision of expert consultants to • Manufacturers • Quality control laboratories • Assistance focuses on • GMP, GCP or GLP compliance • Data development and compilation of dossier • Regulatory guidance • Assistance is separated from the assessment / inspections and may be followed by specific trainings

20. Conditions for provision of technical assistance Manufacturers: • Participation in the prequalification programme, • Found to be capable and willing to improve • Location in a developing country Products: • Inclusion in the list of expression of interest • High value for Public Health purpose • Poor representation on the Prequalification list.

21. Technical assistance2006-2009 (I-X)

22. 3) Provision of information • Information related to individual PQ products or manufacturers / CROs • Product list and pending procedures • Public assessment reports (WHOPAR, SPC, PIL) • Public inspection reports (WHOPIR – APIs and FPPs) • Notice of concern / suspension • Development of guidelines and standards • Published training materials / CDs • Technical Briefing Seminars in Geneva • http://www.who.int/prequal • PQ medicines and laboratories, guidelines, training materials

23. http://www.who.int/prequal/

24. 3) Provision of regulatory expertise • Regulators and manufacturers may benefit from public outcomes of WHO expertise (WHOPARs, WHOPIRs, SPCs) • Learning and reference assessment • Facilitation of national authorizations • Saving capacities for national priorities • Considered • Seminars on PQ medicines submitted for national authorizations • Support to sharing of assessments • Support to regional trainings and rotations

25. Support to rational regulation and development of regulatory systems • Concentration on priority issues most relevant for public health • Improved effectivity and efficiency of work • Co-operation with partners and work-sharing • Facilitated by common standards and administrative requirements

26. Monitoring of outcomes • Feedback from participants of trainings • Pool of assessors, inspectors and trainers • New applications for prequalification or authorization • Quality of submissions and compliance with requested manufacturing standards • Reliability of laboratory quality control • Improvement in efficiency of regulatory processes and inspections

27. Contact for communication Milan Smid, M.D., Ph.D. Quality Assurance and Safety: Medicines (QSM) Essential Medicines and Policy (EMP) smidm@who.int