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October 30, 2015.
The European Medicines Agency (EMA) announced on Oct. 26, 2015 that it now welcomes public consultation on its PRIME program, which seeks to provide enhanced regulatory support for drugs in development that meet unmet medical need. EMA invited comments on the program until Dec. 23, 2015, and the agency published a reflection paper alongside the announcement “outlining the proposed eligibility criteria, procedure, key features, and data requirements for PRIME,” according to the EMA press release.
The launch of PRIME is slated for the first quarter of 2016. PRIME has been likened to FDA’s accelerated approval programs-such as its Priority Review, Breakthrough Therapy, Accelerated Approval, and Fast Track designations-which help fast-track drugs through the regulatory process that appear to have a significant impact on public health.
A medication’s “significant impact” will be measured by the same evaluation standards as those not receiving PRIME support; however, the program will monitor those medications that demonstrate significant evidence of efficacy in clinical trials. The PRIME program will also provide sponsors with preliminary development guidance and will offer enhanced scientific advice during key development milestones. Additionally, another goal of the program goal is to strengthen clinical trial design to tease out more relevant patient information and data that would eventually aid a sponsor in getting market authorization for its drug.
The architects of PRIME believe that the program will particularly compel sponsors from academia. Through PRIME, researchers in these settings would be able to take advantage of the fee incentives that are offered to researchers with convincing nonclinical and tolerability data from preliminary trials and animal studies.