Removal of Antiretroviral Products from the WHO List of Prequalified Medicines

Information and Guidance for Regulatory Bodies, National AIDS Programmes, Doctors and Patients


FREQUENTLY ASKED QUESTIONS

How is it possible that these de-listed products had been prequalified at all?

Up to now the assessment of bioequivalence data (supplied by the manufacturer) was part of the standard procedure for prequalification; regular on-site inspection of the CROs where the bioequivalence studies were done was not. This reflected common practice in many national Drug Regulatory authorities. On 1 May 2004, European Commission Directive 2001/10/EC came into force, demanding that countries carry out such inspections. Given WHO’s commitment to the highest standards, the EC Directive prompted inspections of the CROs carrying out bioequivalence studies (starting with products for priority diseases), which ultimately led to the de-listing of the above five products.

What does it mean for the other products on the list?

All products on the list have been assessed through: evaluation of data in the product dossiers on efficacy, safety, quality and bioequivalence; inspection of manufacturing sites for compliance with good manufacturing practices; and testing of product samples at independent laboratories for compliance with product specifications. In line with the European Directive of 1 May 2004, good clinical and laboratory practices inspections are now being included in the requirements. For example, a recent inspection at the CRO which did the bioequivalence studies for two different strengths of Cipla's triple combination revealed that good clinical and laboratory practices had been followed and that these products (one prequalified in December 2003 and the other in August 2004) are therefore bioequivalent with the originator medicines.

Many national Drug Regulatory authorities do, from time to time, withdraw a registered product. This does not mean that the original registration was unjustified, but that the verification system is rigorous and that the efficacy, safety and quality of registered products continue to be checked after initial registration.

Further Information

Statements on the removal of products can be found at: http://www.who.int/mediacentre/news/releases/2004/pr53/en/
http://www.who.int/mediacentre/news/statements/2004/statement_aidsprequal/en/
More information on the prequalification project, including a full list of WHO prequalified products, is available at http://mednet3.who.int/prequal/
Price information is available from WHO at http://www.who.int/medicines/organization/par/ipc/s&pScreen/S&Pscreen.pdf from MSF at http://www.accessmed-msf.org/documents/untanglingtheweb6.pdf

For more information please contact:
For technical and regulatory issues: André van Zyl, Scientist, Tel: +41 22 791 3598, Mobile: +41 79 475 5527; email: vanzyla@who.int
For clinical and treatment issues: Jos Perriens, Director AIDS Medicines and Diagnostics Service, HIV/AIDS Department, tel +41 22 791 4456, Mobile +41 79 2173422; email: perriensj@who.int
For media enquiries: Daniela Bagozzi, Communications Officer, Tel. +41 22 791 4544, mobile: +41 79 4755490, email: bagozzid@who.int

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