EU launches "PRIME" scheme to pave way for promising medicines
Xinhua, March 7, 2016 Adjust font size:
The European Medicines Agency (EMA) has launched a new PRIME (PRIority MEdicines) scheme, according to a European Commission press release on Monday.
The scheme builds on existing European Union (EU) regulatory tools to strengthen support to accelerate medicines that target an unmet medical need, said the press release.
It offers early, proactive and enhanced support to medicine developers to optimize the production of data on a medicine's benefits and risks, and enable accelerated assessment.
To support earlier access to patients, the Commission has shortened the time frame for adopting decisions that authorize medicines for unmet needs that have been evaluated under an accelerated assessment procedure.
EU commissioner for health and food safety, Vytenis Andriukaitis, said: "The launch of PRIME is a major step forward for patients and their families that have long been hoping for earlier access to safe treatments for their unmet medical needs." Endit