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PRIME: Incentive to support the development of medicines that target an unmet medical need

March 17 2016

The European Medicines Agency (EMA) has recently launched  its new PRIME (PRIority MEdicines) scheme, to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. 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. PRIME builds on the existing regulatory framework and available tools such as scientific advice and accelerated assessment. This means that a PRIME medicine is expected to benefit from accelerated assessment at the time of an application for marketing authorisation.

While PRIME is open to all companies on the basis of preliminary clinical evidence, SMEs and applicants from the academic sector can apply earlier on the basis of compelling non-clinical data and tolerability data from initial clinical trials.

At ttopstart we serve leading researchers and innovative companies exclusively in the fields of life sciences, medical technology and health in more than 19 European countries and the US by acquiring funding for cutting-edge research and development, including for clinical development. Are you thinking about applying for funding for clinical development, but not sure about which funding opportunities to go for? You are always free to contact us to discuss your possibilities.

(Photo credit: jk1991 - http://www.freedigitalphotos.net/)

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