Removal of antiretroviral products from WHO prequalification
Department of Essential Drugs and Medicines Policy; Department of HIV/AIDS
What does the removal of the seven medicines mean?
The list of WHO prequalified products includes medicines which have been evaluated and approved for procurement by United Nations organizations. However WHO is not a supranational regulatory authority. Therefore the list does not have any legal status at national level. In countries, the full responsibility for authorizing marketing and use of medicinal products in public health programmes rests with the national drug regulatory authority.
The standards used by WHO for prequalification are more stringent than those applied by many countries. For example, not all countries legally require in vivo bioequivalence studies for generic drugs; nor do they have stringent requirements for the quality of active pharmaceutical ingredients.
When deciding on the best course of action, national authorities, programmes, prescribers and patients should take the following considerations into account:
- These products may or may not be bioequivalent;
- Interruption of ARV treatment constitutes a serious risk for the individual and may have negative implications from a public health perspective.