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

 
• By Vibha Sharma
  
Generate a summary of this article
Listen to this article
Beta

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.

A new template has been introduced to ensure that all requests for “extended clock-stops” by MAA applicants are “well justified.”...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Europe

EU Biosimilar Filings, Opinions And Approvals

 
• By Saba Afreen

<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>

EU Pharma Reform: What You Need to Know Now

 
• By Anabel Costa-Ferreira and Ian Schofield

As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.

New EU Approvals

<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>

More from Geography

Canada Cuts Red Tape With Single Ethics Review For Trials

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

Nancy Test Circulable Section Geography

 
• By Brian Bossetta

This is a short description

Diversity Action Plans: What To Submit And When

 
• By Nielsen Hobbs

With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.