BEBAC   Ing. Helmut Schütz

Revision of Guideline

EU – EMEA

EMEA’s ‘Committee for Medicinal Products for Human Use’ (CHMP) on its July plenary meeting adopted
CHMP/EWP/1401/98 Rev. 1 (Guideline on the Investigation of Bioequivalence)
for a six-month public consultation period (i.e., until 31 January 2009).

A 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.

BEBAC