Removal of antiretroviral products from WHO prequalification

Department of Essential Drugs and Medicines Policy; Department of HIV/AIDS

Practical implications for national drug regulatory authorities

Additional explanation

The seven products were voluntarily withdrawn by the company since the company found discrepancies in the documentation relating to bioequivalence of the products. However, the products do meet other quality specifications, such as the active pharmaceutical ingredient purity, stability, and manufacture in compliance with Good Manufacturing Practices in a state-of-the-art pharmaceutical plant.

Recommended action

Many national drug regulatory authorities do not require bioequivalence data to admit generic drugs into their markets. In this case there is no legal obligation to withdraw marketing authorization for the seven drugs that were removed. In countries where bioequivalence is required, the national drug regulatory authority should consider one or more of the following actions:

  • Temporarily waive its requirement of bioequivalence for these products as an emergency measure, requesting that the manufactures submit data on new bioequivalence studies within four months (if these deadlines are not met, consider withdrawing marketing authorization);
  • Do not release the products in stock for use until further evidence from new bioequivalence studies becomes available;
  • Withdraw marketing authorization for the products;
  • Provide detailed information and advice to programme managers, prescribers and patients on the best ways to manage the situation without compromising the goals of treatment programmes.