Module 3 2019

The New Active Substance – dossier aspects

New vs. established Drug Substances – what changes from a module 3 viewpoint? • For a known chemical entity, quality standards are already established and are likely to be compendial – often CEP rather than ASMF / full 3.2.S • Physicochemical characteristics and stability of the drug substance is established

• Considerable published literature may be available

The dataset for established drug substances is reduced when compared to the new active substance.

The Organisation for Professionals in Regulatory Affairs