EN PL

EMA: Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances

16.10.2014
This reflection paper aims to clarify some of the expectations of EU competent authorities arising from the guidance found in ICH Q11 (Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) regarding the information to be submitted in marketing authorisation dossiers to justify the selection of starting materials.