The European Medicines Agency would like to inform you that the new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need has been launched today. The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. Through PRIME, the Agency offers early, proactive and enhanced support to medicine developers to optimise the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of marketing applications.
A press release on PRIME and further information have been published on the EMA website, including details on how to apply. In the event of queries, a dedicated e-mail has been set up ( prime@ema.europa.eu).