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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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.
Antimicrobial resistance, the lack of new antibiotics, and preserving the effectiveness of existing ones are high on the agenda for the soon-to-be new head of the European Medicines Agency, Emer Cooke.
The agility, flexibility and transparency that the European Medicines Agency has adopted during the development and assessment of COVID-19 products will have to continue after treatments and vaccines are on the market, says the soon-to-be new head of the agency, Emer Cooke.