As of 1 May 2008, the WHO Prequalification of Medicines Programme implemented biowaivers, based on the Biopharmaceutics Classification System (BCS).
Active pharmaceutical ingredients (APIs) identified to be eligible for BCS-based biowaiver applications:
Until further notice, in vivo bioequivalence studies are required for invited monocomponent and fixed-dose combination products containing other APIs.
document date 2008-05-08 | last update 2022-10-19