Removal of Antiretroviral Products from WHO Prequalification
11 November 2004 ¦ Department of Essential Drugs and Medicines Policy; Department of HIV/AIDS
Next steps by the manufacturers
The company has already presented WHO with a plan indicating proposed dates for the submission of new study reports for these products. The first study is expected to be completed by December 2004. If and when those products and the laboratory meet the specified requirements, WHO will reinstate them in its list of prequalified medicines.
As has been announced previously WHO is in the process of inspecting all other CROs which have conducted bioequivalence studies for prequalified products, starting with priority medicines.
Also, for new applications, WHO has introduced inspections of CROs and laboratories for compliance with Good Clinical Practice and Good Laboratory Practice as a prerequisite for prequalification.
WHO has also started a programme of inspections of manufacturers of Active Pharmaceutical Ingredients (raw materials), with an initial focus on antiretrovirals.