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
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