The European Medicines Agency (EMA) is developing a scheme for priority medicines (PRIME), to optimise the development and accelerated assessment of medicines of major public health interest. The scheme is based on enhanced interaction and early dialogue with medicine developers. EMA expects to launch PRIME in the first quarter of 2016.
Through the scheme, EMA aims to:
• optimise the development and facilitate the accelerated assessment of new priority medicines to benefit patients as early as possible;
• encourage medicine developers to focus on medicines with a potential significant benefit.
EMA launched a two-month public consultation on 26 October 2015 on the key elements of the scheme, including eligibility criteria, procedural aspects, key features and data requirements.