Many patients with serious diseases have no or only unsatisfactory therapeutic options and should be able to benefit from scientific advancement and cutting-edge medicines as early as possible.

The European Medicines Agency (EMA) developed PRIME in line with the European Commission’s priorities and the common strategy to 2020 for the European medicines regulatory network. The goal is 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.

1. 1.  PRIME is driven by patients’ need.
   2. It focuses on medicines that address an unmet medical need, i.e. offers a major therapeutic advantage over existing treatments or benefits patients with no current treatment options for their disease.
   3. It helps to translate research into the development of medicines while meeting regulatory requirements.
   4. It aims to bring promising treatments to patients earlier, without compromising high evaluation standards and patient safety.

Benefits of PRIME for Medicine Developers

1. 1. PRIME helps developers of promising new medicines to optimize development plans.
   2. It fosters early dialogue with EMA to facilitate robust data collection and high-quality marketing authorization applications.
   3. It speeds up evaluation so that medicines can reach patients earlier.
   4. It encourages developers to focus resources on medicines likely to make a real difference to patients’ lives.

This article was originally published on the EMA website. To view the full publication please visit this direct link: http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2016/03/WC500202670.pdf

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