This presentation was given at the 'Beyond Scaling Up: Pathways to Universal Access' workshop which was held at the Institute of Development Studies, Brighton on the 24-25 May, 2010. This event was co-sponsored by the Future Health Systems Research Programme Consortium and the STEPS Centre. Laing presented on the WHO Prequalification of Medicines Programme.

1. WHO Prequalification of Medicines Programme Richard Laing Department of Essential Medicines and Pharmaceutical Policies (EMP) WHO Geneva

3. Web site updated constantly – www.who.int/prequal

5. Prequalification of Medicinal Products: Objectives - Propose a list of prequalified products and manufacturers meeting international norms and standards of which the quality, efficacy and safety has been assessed, inspected and controlled - Ensure that international norms and standards are applied at all the steps of the Prequalification Programme. - Make sure re-evaluation and maintenance of the list are performed and that variations and changes are correctly controlled. - Help the national drug regulatory authorities to build up capacity in assessment, inspection and control meeting international norms and standards. - Develop the local possibilities of production and clinical studies by offering customized technical assistance.

7. Prequalification: the technical documents are WHO normative documents. When these are "silent" other guidelines such as selected ICH guidelines may be used

11. Transparency – dossier status information on the web

12. Transparency – Inspection outcomes on the web

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