Module 3 2019

Terminology

ICH guidelines covers Quality , Safety , Efficacy and Multidisciplinary .

According to ICH, the Quality section of the application covers chemical and pharmaceutical data. According to ICH, The Quality section presents CMC (Chemistry, Manufacturing and Controls) information in a registration dossier.

Synonym for CMC: Chemistry and Pharmacy

Synonym for drug substance: API (Active Pharmaceutical Ingredient), active substance

The Organisation for Professionals in Regulatory Affairs