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Europe takes a page from the FDA with new speedy approval program

March 7, 2016 | By Damian Garde
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1	EMA Executive Director Guido Rasi

European drug regulators launched a new program designed to speed up the development of drugs for underserved diseases, mirroring the FDA's breakthrough therapy program with an initiative that promises faster approvals for game-changing medicines.
Called Priority Medicines, or PRIME, the European Medicines Agency's new effort will select innovative R&D projects and enroll them into a program that gives drug developers early and frequent access to regulators. The idea, the EMA said, is to increase the odds of clinical success by providing feedback at each stage of development, helping companies design the right trials and enroll the ideal patient populations.
"Our goal is to foster better planning of medicine development to help companies generate the high-quality data we need to assess quality, safety and efficacy of medicines," EMA Executive Director Guido Rasi said in a statement. "Patients with no or insufficient treatments could then benefit from scientific progress and cutting edge medicines as soon as possible."

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The initiative is much like the FDA's breakthrough therapy designation, launched in 2012, which similarly guarantees access to agency officials and gives drugmakers a shot at early approval. The FDA has handed out more than 110 such designations over the past four years, granting approval to 30 drugs in the program.
To get in on the PRIME program, drugmakers must submit early clinical data that demonstrates their product has the potential to treat an unmet medical need, EMA said. Once accepted, the EMA appoints a member of the Committee for Medicinal Products for Human Use to provide feedback on development, bringing together a multidisciplinary group of experts to provide guidance on how drugmakers should move forward. From there, the agency doles out scientific advice as trials progress, simultaneously mapping out a path to an accelerated EMA review.
The U.K. has already established a similar program of its own, in 2014 launching the promising innovative medicines designation in an effort to identify breakthrough drugs early and speed up their path to patients.
- read the announcement (PDF)
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