1. The WHO Prequalification of Medicines Programme Capacity building agenda
Dr Milan Smid

2. WHO Prequalification of Medicines Programme
To increase access to priority medicinal products of acceptable unified standards
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
Prequalification of Quality Control Laboratories
Inspections and evaluations
Testing projects
Capacity building
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4. 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
Next we will have a short session on Self-inspection.
We then turn to the topic of Personnel. Personnel should be seen by the pharmaceutical manufacturer as its most valuable resource. It is sometimes its most difficult one to manage. Inspectors need to be sure that there are sufficient human resources, with people who have the correct qualifications and acceptable levels of experience. An important issue for you to check is the conflict of interest that can arise if Quality Control is not properly independent of Production. For this reason a full day is required for this subject.
This will be followed by a half-day session on Equipment. If you would like to have any particular piece of equipment discussed please write its name down and hand it to me at the end of this module. If possible we will discuss the item during the Equipment module.
We shall then spend a full day on Premises. Here we are going to be looking at some of the fundamental issues, including the effect of the external environment, on a company’s ability to manufacture products in the appropriate conditions.
This will be followed by a half-day session on Materials. Experience has shown that many problems arise as a result of the selection of unsuitable or impure materials. Many developing countries have financial constraints that work against using materials of the right quality.
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5. 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)
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6. Capacity building – team work
1) Trainings of different set-up and PQ advocacy
2) Technical
assistance &
advice
3) Provision of information,
standards and regulatory
expertise
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7. 1) Trainings - seminars 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)
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8. 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
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14. Topics of workshops
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15. Therapeutic focus of workshops 2006-2010 (I-VIII)
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16. Training by doing
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
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17. 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
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18. 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
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19. (I-IX)
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20. Assistances provided in individual countries 2006-2011 (I-VI)
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21. Technical assistances in WHO regions 2006-2011 (I-VI)
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22. 3) Provision of information and regulatory expertise
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
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
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23. 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
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24. 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
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25. implement new GMP standards
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)
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26. 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
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27. Thank you for the attention
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