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EMA Tightens Clock-Stop Rules To Address Impact On Drug Approval Timelines

 
• By Vibha Sharma

The European Medicines Agency says that in 2022, the average time taken up by clock-stops exceeded the average time of drug assessment.

Hand stop time on clock, deadline concept
Clock-stops occur when companies need additional time to respond to CHMP questions • Source: Shutterstock

The European Medicines Agency is getting stricter with companies who ask for more time to deal with the questions and issues raised by the agency while reviewing their new drug marketing authorization applications (MAAs) via the centralized procedure.

Key Takeaways

  • The European Medicines Agency is concerned that companies are requesting for longer clock-stops to respond to questions regarding their drugs under review.

  • This is...

A new template has been introduced to ensure that all requests for “extended clock-stops” by MAA applicants are “well justified.” The focus is now on clamping down on unjustified requests,...

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