The WHO Prequalification of Medicines Programme Capacity building agenda

Dr Milan Smid

WHO Prequalification of Medicines Programme

•

To increase access to priority medicinal products of acceptable unified standards

1. Prequalification of medicines (FPPs and APIs) – 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 2. Prequalification of Quality Control Laboratories – Inspections and evaluations – Testing projects 3. Capacity building 2 TBS, Nov 3, 2011

3 TBS, Nov 3, 2011

• • •

Capacity building - objectives

Good quality submissions for PQ supported by compliance with "good practices" – platform for improvement of drug development, manufacturing, documentation and quality control Fast regulatory approvals of PQ medicines in recipient countries – technical education of regulators as a platform for strengthening expertise, regulatory efficiency and networking Reliable quality monitoring – technical education of staff of QCLs to strengthen expertise, effectiveness of quality monitoring and networking PQP standards and PQP example support strengthening of regulatory systems and capacity of manufacturers in general 4 TBS, Nov 3, 2011

Capacity building - stakeholders

• 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) 5 TBS, Nov 3, 2011

Capacity building – team work

1) Trainings of different set-up and PQ advocacy 2) Technical assistance & 3) Provision of information, advice standards and regulatory expertise

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1) Trainings - s

eminars and workshops

– – – – – – – General: PQ procedures and WHO requirements Problem oriented, e.g.: – HIV/AIDS, TB, antimalarial or RH products – Pharmaceutical development/paediatric dosage forms, BE/BCS – Manufacture of sterile medicines – Quality of APIs – Bioequivalence testing Trainings of NRA staff and manufacturers frequently combined Collaboration with third parties frequent involved Support is given to trainings organized by others Focus on "training of trainers" WHO training materials used, when available (GMP, GPCL) 7 TBS, Nov 3, 2011

Main partners in organization of trainings

• • • • • • • • • • • • • International Pharmaceutical Federation (FIP) European Directorate for the Quality of Medicines & Healthcare (EDQM) National Regulatory Authorities in South Africa, Tanzania, Estonia, Ethiopia, 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 8 TBS, Nov 3, 2011

25 Workshops and meetings organized or supported by PQP 20 5 12 15 4 4 10 11 5 0 2006 4 2007 9 2008 2009 5 12 16 13 2010 2011/IX PQP supported PQP organized

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Participants in workshops and meetings organized or supported by PQP 1400 143 52 1200 73 130 303 1000 203 800 600 44 49 282 400 57 103 198 301 805 894 396 200 263 165 0 2007 2008 2009 2010 2011/IX Others QCL staff Regulators Manufacturers

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80 70 60 Countries represented in workshops and meetings co/organized by PQP 79 76 56 59 52 50 40 30 20 10 0 2007 2008 2009 2010 2011/IX

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Trainings organized by PQP in WHO regions Share of individual countries (2006 - 2010) 10 8 2 0 6 4 18 16 14 12 AFRO AMRO EMRO EURO SEARO WPRO

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Topics of workshops

2006-2010

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10 2 3 12 10 8 9 8 Prequalification advocacy Prequalification requirements Good manufacturing practice Quality control Bioequivalence/BCS and GCP Assessment of medicines Pharmaceutical development and quality API quality PQ general/Regulatory 21

Therapeutic focus of workshops

2006-2010 (I-VIII) 1 4 7 5 2 HIV/AIDS medicines TB medicines Pediatric formulations Antimalarials RH products

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Training by doing

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Training of regulatory staff by involvement in PQP activities

– – – Involvement of assessors from NRAs in PQ assessment Involvement of inspectors from NRAs in PQ inspections Rotations of experts from NRAs in WHO HQ 16 TBS, Nov 3, 2011

2) Technical Assistance

• • • • •

Key objective: Facilitate prequalification of priority medicines

Provision of consultants to advice on – GMP or GCP compliance – Data development and compilation of dossier Assistances are separated from the assessment / inspections Assistances may include specific trainings Assistance is provided in principle free of charge 17 TBS, Nov 3, 2011

Conditions for provision of technical assistance

• • •

Manufacturers:

Commitment to participate 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 Poor representation on the Prequalification list Prioritised for Public Health purpose 18 TBS, Nov 3, 2011

2006-2011 (I-IX) Technical assistances organized by PQP 30 25 20 15 10 5 0 2 3 1 2 2006 3 10 8 2008 1 2 7 8 4 14 2010 3 4 4 9

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REG GPCL GCP GMP

10 5 0 30 25 20 15 Assistances provided in individual countries 2006-2011 (I-VI) 40 35 GMP GPLC GCP REG

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Technical assistances in WHO regions

2006-2011 (I-VI) 20 15 10 5 0 45 40 35 30 25 AFRO AMRO EMRO EURO SEARO WPRO REG GCP GPLC GMP

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3) Provision of information and regulatory expertise

Information related to individual PQ products or manufacturers / CROs http://www.who.int/prequal – Product list and pending procedures – – Public assessment reports (WHOPAR, SPC, PIL) Public inspection reports (WHOPIR – APIs and FPPs) – Notice of concern / suspension – – Guidelines and standards PQ laboratories – Training materials Published training materials and standards / CDs Availability of non-WHO standards (PhEur, ICH) Technical Briefing Seminars in Geneva 22 TBS, Nov 3, 2011

Support to rational regulation and development of regulatory systems

• Concentration on priority issues most relevant for public health in countries relevant for PQP • Mostly on invitation of WHO offices or national governmental institutions • Improved effectivity and efficiency of work • Co-operation with partners and work-sharing – Facilitated by common standards and administrative requirements 23 TBS, Nov 3, 2011

WHO Projects Organized in Cooperation with SFDA in China

Focus on quality and safety of medicines, sponsored by •

Bill and Melinda Gates Foundation (BMGF)

– To improve TB control in China by increasing national capacity to produce fixed-dose combination (FDC) anti TB medicines of assured quality and to regulate TB FDC drugs •

Global Fund to Fight HIV/AIDS, TB and Malaria (GFATM)

– To improve the quality of anti-TB, HIV/AIDS and malaria medicine produced in China to ensure improved accessibility and patient outcomes 24 TBS, Nov 3, 2011 24

Generalized objectives of both projects

• • • achieve quality assured production of TB FDC, HIV and malaria drugs in China and strengthen their role on domestic market and increase export opportunities implement new GMP standards move towards WHO prequalification. WHO prequalification functions as a gate-keeping mechanism to enter international tenders and procurement is growing • No direct financial support to manufacturers through this project but Technical Assistance (TA) 25 TBS, Nov 3, 2011 25

Monitoring of capacity building 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 standards of good practices • • Reliability of laboratory quality control Improvement in efficiency of regulatory processes and inspections 26 TBS, Nov 3, 2011

Thank you for the attention [email protected]

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