Why Four In Five Applications For PRIME Still Fail Two Years On: EMA Clarifies Expectations
The European Medicines Agency’s priority medicines scheme, PRIME, attracts a lot of applications, but most of them fail. The agency has explained why and has updated it guidance documents for applicants.
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Last year saw the number of applications accepted onto the European Medicines Agency’s priority medicines scheme inch up and the notoriously high rejection rate for applications drop.
Nine of the 70 medicines for unmet medical needs that have to date won a place on the European Medicines Agency’s PRIME scheme are now approved for sale in the EU, and two more approvals are expected soon. Meanwhile, most applications for a "priority medicine" designation are still missing the mark.
Two companies are set to learn whether the European Medicines Agency will agree that their planned EU marketing applications merit an accelerated assessment.