EBE comments on quality guideline (EMA/CHMP/BWP/247713/2012)

05 Jun 2014

EMA published the final version of the Quality guidelines, following approval by Committee for Medicinal Products for Human Use (CHMP) at the end of May 2014.
14 stakeholders submitted comments. European Biopharmaceutical Enterprises (EBE), stakeholder No 5, of a total of 43 comments, 25 were accepted / partly accepted / acknowledged, while some 18 were not accepted.

You may read EBE’s comments here

2017-09-01T14:40:47+00:00June 5, 2014|