The European Medicines Agency (EMA) launched the Priority Medicines (PRIME) scheme in March to speed up the development of promising medicines. PRIME is similar, but not identical, to the FDA's breakthrough therapy programme, which the US regulators launched in 2012.

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PRIME is aimed at medicines that could offer a major therapeutic advantage over existing treatments, or that will benefit patients with no treatment options, given early-stage clinical data. Large pharmaceutical companies are eligible after completing proof-of-concept trials, whereas smaller companies and academic groups can apply as soon as they have compelling non-clinical data and tolerability data from initial clinical trials. Because small companies and academic groups generally have less experience with the regulatory framework, they could benefit in particular from earlier scientific and regulatory advice, the agency noted.

Successful applicants will gain access to earlier interactions with the EMA's representatives, scientific advice from regulators and speedier assessment timelines. The big wins will come from being able to plan better clinical trial programmes, said Tomas Salmonson, Chair of the agency's Committee for Medicinal Products for Human Use (CHMP). “For some [drugs] there may be very limited benefits. For others, I'm convinced there will be a significant gain.”

A recent analysis of the FDA's breakthrough programme found that breakthrough-designated cancer drugs spent on average 5.2 years in clinical trials, compared with an average of 7.4 years for non-designated drugs (Nat. Rev. Drug Discov. 15, 152; 2016). Because the breakthrough programme is still young, and because some of the designated drugs were already well into their clinical trials when they received breakthrough designation, it is unclear how much of this gain is attributable to the additional support that sponsors received from the FDA.

Salmonson added that the PRIME scheme is just one part of the regulatory jigsaw puzzle. PRIME candidates can also benefit from other regulatory tools, such as the agency's conditional marketing pathway, a temporary approval that can be granted in the absence of comprehensive clinical data, and its parallel scientific advice process, which provides drug development guidance from health technology assessment (HTA) groups (Nat. Rev. Drug Discov. 13, 8; 2014).

The EMA expects approximately 100 submissions for PRIME eligibility per year, but Salmonson cautioned that “a large number of the applications will be turned down.” When the FDA launched its breakthrough programme it anticipated granting only a few designations per year. It has already granted the designation to over 100 products.

The EMA will publish monthly statistics on the uptake of the programme.