Removal of Antiretroviral Products from the WHO List of Prequalified Medicines

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


Next steps by the manufacturers

The manufacturers have indicated that they will resubmit the products in question to a different laboratory for new bioequivalence studies. If and when those products and the laboratory meet the specified requirements, WHO will reinstate them in its list of prequalified medicines.

Next steps by WHO

  • WHO will make available to national drug regulatory authorities, upon request and under confidential cover, the inspection reports on the de-listed products.

  • As soon as new bioequivalence data of the de-listed products have been received WHO will arrange for immediate data assessment and site inspections, to minimize administrative delays in the potential re-listing of the products.

  • WHO will send a letter to all manufacturers of prequalified products, asking them to take all necessary measures to ensure that the data submitted to WHO are correct and complete, and to check that CROs have followed the appropriate standards.

  • As a matter of urgency, WHO will inspect all other CROs which have conducted bioequivalence studies for prequalified products, starting with priority medicines.

  • For new applications, WHO will introduce inspections of CROs and laboratories for compliance with Good Clinical Practice and Good Laboratory Practice as a prerequisite for prequalification.

  • WHO will also start a programme of inspections of manufacturers of Active Pharmaceutical Ingredients (raw materials), with an initial focus on antiretrovirals.