Requests For EMA PRIME Designation Fall But Improvements Are On The Way

While the European Medicines Agency and industry speculate as to why 2022 saw far fewer applications for a place on the priority medicines scheme for drugs for unmet medical needs, they are enthusiastic about improvements to the initiative that are set to be trialed soon.

The PRIME scheme can help drug developers understand how to generate robust data • Source: Shutterstock

The number of investigational drugs that the European Medicines Agency accepted onto PRIME, its scheme for promising medicines for unmet medical needs, fell to a record low in 2022. Thirteen products secured a place on the program, compared with the all-time high of 20 in 2020.

Last year also saw far fewer applications than usual being submitted for a PRIME designation. Only 40 requests received a...

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