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‘Positive & Productive’ – US, EU Regulators On First Collaborative CMC Change Assessment

 
• By Neena Brizmohun

An application to add new manufacturing and quality control sites for a oncology biologic was approved in the US and the EU on the same day, a move that was said to be “a significant accomplishment” in aligning the regulators in each region on the assessment process and timeline.

Map of the planet
Getting manufacturing changes approved around the world can be a complex and time-consuming business • Source: Shutterstock

There has been a positive outcome from the first collaborative assessment by regulators taking part in an international pilot exploring how to make it easier for drug companies to make post-approval manufacturing changes in different countries and ensure the supply of critical medicines.

The assessment, which involved US and EU regulators evaluating an application to add new manufacturing and quality control sites for a oncology biologic, was completed under the four-month goal window for a standard manufacturing

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