China Joins ICH in Pursuit of Global Harmonization of Drug Development Standards

Theresa M. Mullin, Ph.D. of FDA reports “I am pleased to have been in China recently, when the China Food and Drug Administration (CFDA) submitted its membership application to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (also known as the International Council for Harmonisation or ICH).” Click here for the full story. Despite ICH guidelines, differences between European and US eCTD NDA submissions remain. Click here for help with converting your eCTD NDA submission to FDA or EMA standards.