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EMA Says No To Extending Clock-Stops For Immature Marketing Applications

Companies Should Ensure Dossiers Are As Mature As Possible From Day One

 
• By Vibha Sharma

The European Medicines Agency wants to discourage drug companies from submitting marketing applications with very interim data cuts and then expecting they can supplement their application with more data later on by requesting for extended clock-stops.

Close up Businessman in Black Suit Showing Time Out Sign, Isolated on Gray Background.
Companies Are Increasingly Asking For More Time To Respond To EMA’s Questions (Shutterstock)
Key Takeaways
  • The European Medicines Agency is clamping down on delays to its evaluation process caused by companies asking for extended clock-stops.
  • Companies are increasingly submitting only interim data in their drug marketing applications, assuming they will be able to supplement it later by asking for longer clock-stops.
  • The EMA is applying strict criteria on allowing clock-stop extensions specified in its 2009 guideline.
  • As a result, requests for extended clock-stops due to immature application dossiers are no longer being granted.
  • If a clock-stop extension is refused, it could have major consequences for a company, including the agency adopting a negative opinion for a product.

The European Medicines Agency says it has seen an increasing trend among companies submitting interim data in their drug marketing authorization applications (MAAs), with the hope that they will be...

It has warned companies to stop this practice, saying it is no longer entertaining requests from sponsors to pause its evaluation of the MAA for extended periods without good reason....

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