Paving the way for promising medicines for patients: European Medicines Agency (EMA) launches PRIME scheme
In March 2016, a new scheme called PRIME was launched by the European Medicines Agency (EMA). PRIME stands for Priority Medicines and was developed to benefit patients with serious diseases and no or few treatment options. PRIME supports the development of medicines which target an unmet medical need, bring a major therapeutic advantage to patients and are not on the market yet. For a successful application, these conditions must be proved on the basis of early clinical data.
In order to give patients access to relevant drugs as soon as possible, PRIME aims at speeding up the evaluation process by enhancing dialogue with the medicine developers, by optimising development plans and by helping with the application from an early stage on. In particular, SMEs and academia are meant to benefit from the scheme because they tend to be less familiar with the regulatory framework and can profit from PRIME right from the start.
The attractive new scheme PRIME and the MYOCURE project share the goal to foster research on and development of medicines for patients whose diseases cannot be treated or who need better treatment options to help them live healthier lives.