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ICH Explores New Platform To Facilitate Global Evaluation Of CMC Changes

 
• By Vibha Sharma

An ongoing collaborative initiative involving global regulators assessing post-approval manufacturing changes has highlighted the need to establish a standardized platform that can facilitate the submission and regulatory evaluation of such changes.

Tablets, pills and capsules, that shape the map of the world.
Aligning Global Requirements For Post-Approval Manufacturing Changes Can Reduce Regulatory Burden On Companies • Source: Shutterstock

The International Council for Harmonisation will soon be launching a formal process to gather information from potential IT vendors on whether it is possible to develop a secure, standardized regulatory platform that drug sponsors can use to submit post-marketing chemistry, manufacturing and controls (CMC) changes for evaluation by multiple regulators.

A standardized, secure platform can streamline the submission and assessment of CMC-related post-approval changes and ensure that regulatory authorities evaluate these changes

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