Part 1: Overview of the WHO / UN Prequalification Programme

1. QUALITY REPRODUCTIVE HEALTH SUPPLIESDr Hans V. HogerzeilDirectorEssential Medicines & Pharmaceutical Policies

2. Part 1: Overview of the WHO / UN Prequalification Programme

3. Prequalification objectives • Produce list of prequalified products(for priority therapeutic areas), and of manufacturing sites,that meet international norms and standards for quality, efficacy and safety • Produce list of PQedmedicine control laboratories that meet international norms and standards for quality, efficacy and safety • Ensure re-evaluation andmaintenanceof the list of PQed medicines, including assessment of variations and changes • Help national drug regulatory authorities build capacity in assessment, inspection and control • Develop local capacity in manufacturing production and clinical studies by offering customized technical assistance

4. Recent developments In addition to PQ of 241 medicines and 14 QCLs to date: • concept of medicines quality better and more widely understood by countries, partner agencies and manufacturers • increased access to quality-assured priority medicines products; more supplier security, more price competition • more rapid development of some quality products through provision of standards, technical assistance and training • faster regulatory approval of some products e.g. by making info about PQed products and evaluation/ inspection outcomes publicly available • monitoring and evaluation of the quality of medicines circulating on the market: large difference between PQ-ed and non-PQed

5. Products prequalified PQed 2010 to date: - 3 HIV/AIDS - 2 TB

6. Products prequalified, by therapeutic category

7. Number of inspections 2005–2009

8. Number of dossiers assessed 2007–2009

9. Training & capacity building 2007–2010

10. Technical assistance to manufacturers, CROs and QCLs by year 2006–2010 and WHO region

11. Quality control laboratories: Prequalified or interested in becoming prequalified Prequalified QCLs in: • Algeria • Canada • France • India • Kenya • Morocco • Singapore • South Africa • Ukraine • Vietnam

12. New directions • Survey of manufacturers of prequalified products: use the results to improve PQP services • Targeted outreach to potential new manufacturer applicants • Focus on improving quality of active pharmaceutical ingredients • Joint dossier assessments (between countries) • Assess value to manufacturers of WHO prequalification • Assess benefits to partners of WHO prequalification

13. Challenges • Increasing number of variations • Reducing timelines to prequalification • Funding for PQ of RH products ends on 31 May 2010 • Procurement practices by agencies do not always follow and support WHO/UN prequalification • Lack of harmonized regulatory standards in countries; national authorities don't effectively use PQP's information for registration

14. Part 2: PQP's experience of prequalifying reproductive health products

15. Invitations to manufacturers of RH products to submit expression of interest for product evaluation (EOIs) 1st Invitation - October 2006 Oral and injectable hormonal contraceptives 2nd Invitation - December 2007 Prevention and treatment of post-partum haemorrhage and ecclampsia 3rd Invitation - May 2008 Extended to injectable hormonal contraceptives and oxytocics, implant 4th Invitation - July 2009 Extended to oral, injectable and implantable hormonal contraceptives 5th Invitation - May 2010 Deletion of lynestrenol, better specification for oxytocin and mifepristone

16. 37 RH product dossiers submitted to PQP to date

17. RH medicines submitted, by country

18. Submissions by R&D and 'generic' companies

19. Reasons for rejections and cancellations Multisource • Data in dossier do not demonstrate product quality - API or FPP data • Bioequivalence is not demonstrated • GMP standard is not acceptable (premises, QA) Common denominator: lack of experience, lack of technical skills and lack of co-operation R&D companies • Product is not invited for prequalification • Product is not identical as approved by stringent authority • Product assessment is not documented by stringent authority

20. Workshops focused on therapeutic groups 2006–10

21. Benefits for manufacturers of participating in prequalification • Potential for increased financial profit • by meeting requirement of procurers and sponsors • participation in global market and international tenders • Enhanced reputation • Access to technical support– opportunity to save resources and to increase competitiveness • Facilitation of national registration in recipient countries and in "regulated" markets • PQP levies no charges for services

22. Manufacturers' reasons for not participating in PQP • The need to make human and financial investments • A lack of technical and regulatory skills • Not yet ready to participate globally • Differences between PQP and national regulatory requirements • Varying requirements and standards of procurers • Risk of losing traditional markets once defined as sub-standard !

23. How can we promote prequalification and quality among RH manufacturers? • Increases understanding of RH quality issues among procurers and international donors • Procurement agencies stop buying poor-quality RH products: • develop joint QA policy, harmonize requirements • make manufacturers aware of joint QA policy • publicly set target date for implementation of QA policy (i.e. deadline for suppliers to meet new QA requirements) • PQP analyses barriers to investing in improving quality and defines incentives for encouraging such investment • PQP secures donor funding for providing enhanced support to RH manufacturers aimed at prequalification !

24. Recommended actions for improving quality procurement • Invest sufficient financial and human resources into quality assurance • Quality assurance costs 2 - 2.5% of procurement value • Procurement organizations are legally liable for the quality of the products • Develop and publish an agency quality assurance policy • Define and confirm agency's long-term commitment and plan of action • Serves to inform consumers / recipients • Good example: the quality policy of the Global Fund (2009) • Promote and use the WHO/UN Prequalification Programme • Inform and set deadline to manufacturers • Make specific arrangements for the (temporary and exceptional) procurement of items neither prequalified or approved by SRA • WHO Expert Panel Review for risk-based advice on alternative suppliers • Offer specific quality procurement training to key staff • Hold meeting with WHO to discuss draft plan, define concrete steps