BEBAC  Ing. Helmut Schütz


Guideline on the Investigation of Bioequivalence

The new Guideline (CPMP/QWP/EWP/1401/98 Rev. 1) was adopted by CPMP on 20 January 2010 and published on 29 January 2010.
The Guideline is effective with 1 August 2010.

This guideline replaces the “Note for guidance on the investigation of bioavailability and bioequivalence” CPMP/QWP/EWP/1401/98 and the related Q&A document (CHMP/EWP/40326/06).
This guideline includes recommendations on BCS-based biowaivers.

A separate document (EMA/CHMP/EWP/26817/2010: 248 pages, 1.5MB) presenting comments received by EMA on the draft guideline was published on 10 February 2010.