BEBAC   Ing. Helmut Schütz

Prequalification Update

WHO

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.