Spring Intro 2023

28/03/2023

Where does CMC fit in the Corporate Regulatory Landscape?

Global RA

Regional RA

BOH facin g

R&D facing

Country / Affiliate RA

Regional CMC

Global CMC

Site based CMC

Manufacturing facing

The Organisation for Professionals in Regulatory Affairs

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Core focus of CMC Regulatory Affairs

Deals with a significant core element of a new drug Submission (Module 3) and updates. Technically very broad and complex, spanning drug development, manufacturing technology, Analytical technology, Medical devices, pharmacokinetics Rendered even more complex because of: - Advancement of regulatory science, driven by ICH process - Advancement in technology platforms that deliver new medicines (e.g. biologics, cell & gene) - Advancement in technology for existing platforms (PAT, continuous manufacturing) - Increasing complexity and sophistication of global and regional CMC requirements - Quality and Compliance considerations (e.g. Nitrosamine issue) High level of CMC Regulatory activity throughout lifecycle

The Organisation for Professionals in Regulatory Affairs

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