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PRIME: How The EU Scheme Is Delivering On Promise Of Faster Drug Approvals

 
• By Neena Brizmohun

Nineteen new products that were developed under PRIME, the European Medicines Agency’s priority medicines scheme, are now approved for use in the EU. Pink Sheet analysis finds that many were reviewed much faster than they would have been under standard review timelines.

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The PRIME scheme can lead to faster regulatory reviews • Source: Alamy

Seven advanced therapies, eight chemical drugs, three biologics and one immunologic. Seventeen treatments for rare diseases. Accelerated assessment status often granted but also frequently withdrawn. And, in many cases, shorter regulatory review times than is standard.

A total of 19 treatments have now been approved in the EU following their development under PRIME, the scheme that the European Medicines Agency launched in March 2016 in an effort to help drug developers optimize their product development plans and, in

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