The WHO Prequalification of Medicines Program - Introduction

Tony Gould Manager, Prequalification of Medicines Program

WHO

Technical Briefing Seminar, 1-5 November 20102

The Prequalification of MedicinesProgramme - 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

Technical Briefing Seminar, 1-5 November 20103

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

Technical Briefing Seminar, 1-5 November 20104

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

Technical Briefing Seminar, 1-5 November 20105

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

Technical Briefing Seminar, 1-5 November 20106

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

Technical Briefing Seminar, 1-5 November 20107

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)

Technical Briefing Seminar, 1-5 November 20108

Medicines prequalified by WHO

020406080

100120140160180200

HIV/AIDS

TuberculosisMalaria

Reproductive health

Influenza

Total: 246 products

(at 27 October 2010)

Technical Briefing Seminar, 1-5 November 20109

Thank you for listening!

Further information: http://who.int/prequal/Email: prequal@who.int