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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 pilot project run by the International Coalition of Medicines Regulatory Authorities to make it easier for companies to request...

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