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

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.”...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.

EU’s Life Sciences Strategy Faces Race Against Time, Says Clinical Trials Community

 
• By 

The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.

More from Geography

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.