1. The WHO Prequalification of Medicines Program - Introduction Tony Gould Manager, Prequalification of Medicines Program WHO

2. Technical Briefing Seminar, 1-5 November 2010 2 The Prequalification of Medicines Programme - Introduction A United Nations Programme managed by WHO Started in March 2001 as a Pilot Project: Focus on HIV/AIDS Partners included WHO, UNICEF, UNFPA, UNAIDS and supported by World bank Quickly expanded to include Tuberculosis, Malaria, RPHP, Influenza and others Funded by donors – mainly UNITAID and Bill and Melinda Gates Foundation

3. Technical Briefing Seminar, 1-5 November 2010 3 PQ Programme objectives Contribution to the United Nations priority goal of addressing widespread diseases in countries with limited access to quality medicines In cooperation with National Regulatory Agencies and partner organizations, make quality priority medicines available for the benefit of those in need

4. Technical Briefing Seminar, 1-5 November 2010 4 Scope of prequalification Limited to priority essential medicines as published in invitations for Expression of Interest (EOI) on Prequalification website Medicines eligible for PQ determined by WHO disease departments All are on the WHO List of Essential medicines

5. Technical Briefing Seminar, 1-5 November 2010 5 PQ Programme components Evaluation of Quality, Safety and Efficacy of prioritised essential medicines Inspection of manufacturers, CROs and QC labs Monitoring of the products after prequalification Prequalification of quality control laboratories Building capacity of regulators, manufacturers and quality control laboratories

6. Technical Briefing Seminar, 1-5 November 2010 6 Key outputs Published list of prequalified medicinal products used for HIV/AIDS, malaria, tuberculosis, influenza and for reproductive health – Used principally by UN agencies, including UNAIDS and UNICEF, and any other agency or organization involved in bulk purchasing of medicines, to guide their procurement decisions Published list of prequalified laboratories – The list may be used by any organization to ensure that testing for quality monitoring is done at an acceptable standard

7. Technical Briefing Seminar, 1-5 November 2010 7 Key outputs Published list of prequalified APIs – Can be used by finished product manufacturers to assure the quality of APIs – Can be used by national medicines regulatory authorities who wish to verify the standard of APIs that have been used to manufacture nationally registered medicines Procedure implemented in October 2010 Based on APIMF assessment and inspection of manufacturer(s)

8. Technical Briefing Seminar, 1-5 November 2010 8 Medicines prequalified by WHO Total: 246 products (at 27 October 2010)

9. Technical Briefing Seminar, 1-5 November 2010 9 Thank you for listening! Further information: http://who.int/prequal/http://who.int/prequal/ Email: prequal@who.int