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Global Regulators Consider Extending Pilot On Post-Approval CMC Changes After Positive Findings

 
• By Eliza Slawther

Regulatory authorities from multiple regions are considering extending a pilot project related to collaborative assessments of post-approval chemistry, manufacturing and controls changes, with a focus on the supply of critical medicines.

The pilot focused on regulatory alignment in the area of chemistry, manufacturing and controls (Shutterstock)
Key Takeaways
  • The International Coalition of Medicines Regulatory Agencies is planning to extend and expand a pilot exploring collaborative assessments for post-approval chemistry, manufacturing and controls changes.
  • A report found that industry had a positive experience with the pilot, and that it led to fewer information requests from regulators.
  • While the pilot led to an increased workload for the regulators involved, it was still a valuable experience for regulators that led to convergence between national agencies.

A pilot project run by the International Coalition of Medicines Regulatory Authorities to make it easier for companies to request post-approval manufacturing changes has resulted in positive outcomes, particularly for...

The pilot “achieved its stated objectives,” which were to enable drug companies to submit applications for chemistry, manufacturing and controls (CMC) post-approval changes for simultaneous assessment by multiple regulatory authorities,...

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