Launch of PRIME
The European Medicines Agency (EMA) launched on March 7, 2016 its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need.
The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. These medicines are considered priority medicines within the European Union (EU).
Through PRIME, EMA 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 medicine applications.
This will help patients to benefit as early as possible from therapies that may significantly improve their quality of life.
By engaging with medicine developers early, PRIME aims to strengthen clinical trial designs to facilitate the generation of high quality data for the evaluation of an application for marketing authorisation.
Early dialogue and scientific advice also ensure that patients participate in trials that are likely to provide the necessary data for an application for marketing authorisation, and help to make best use of limited resources.
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