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ICMRA’s Pilot On Hybrid Inspections And CMC Changes Seeks Participants

 
• By Bowman Cox

Driven by COVID-19 pandemic challenges, regulatory authorities from multiple regions want to work with sponsors on new joint approaches for expediting manufacturing changes globally and streamlining preapproval and pre-licensing inspections.

Door to change
pilots may open door to change • Source: Shutterstock

A coalition of pharmaceutical regulatory authorities on 24 June invited proposals from pharmaceutical companies to participate in joint pilot assessments that could help smooth the way for post-approval chemistry, manufacturing and controls changes and hybrid on-site/remote inspections.

The International Coalition of Medicines Regulatory Authorities said it aims to complete three collaborative CMC assessments and three collaborative hybrid inspections over a 12- to 18-month period,

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• By Sue Sutter

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US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
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US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
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