Outside of Module 1, much of the documentation and data required for regulatory submissions related to CMC activities in Tier 1 countries is consistent, allowing pharmaceutical organizations an opportunity to develop a single dossier to be used for all submissions throughout Tier 1 countries. Development of CMC sections of filings that are comprehensive and appropriate to be filed in multiple countries and regions will ultimately reduce timelines, potentially bringing products to market more quickly. These data rich dossiers seek to provide comprehensive data surrounding CMC, ensuring regulatory agencies in a variety of regions have the required information in order to provide product clearance and continued regulatory support.
- Critical components of single dossier formats
- Challenges in development and writing of modules
- Areas of differentiation related to CMC filings
- Cost benefit analysis of single CMC dossiers
- Applying the single dossier to non-Tier 1 filings
Melissa Mertzman, PhD, RAC
Associate Director, Dossier Development & Operations