EMA released a report presenting results from the first two years of its “PRIority MEdicines” scheme (PRIME), intended to support the development and approval process for therapeutic areas with the most pressing unmet medical needs. The report explains how the criteria for eligibility to the scheme has been applied and the type of support applicants have received. Since the launch of PRIME in March 2016, EMA has received and assessed a total of 177 requests for eligibility, 36 or about 20% of which have been accepted. Of these: ● 30 concern rare diseases ● 16 are intended to treat pediatric patients, and ● 15 are ATMPs. [See IPQ Nov. 29, 2016 for more on EMA’s PRIME scheme.]
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