The European Medicines Agency (EMA) announced, on Wednesday 5 April, following an analysis of the experience acquired during the first five years of operation, that it is proposing new features under the PRIority MEdicines (PRIME) programme.
PRIME was set up to facilitate the development of promising medicines that have the potential to significantly address patients’ unmet medical needs.
Through PRIME, the EMA offers support in the form of scientific and regulatory support to medicine developers who participate in the programme on a voluntary basis.
This support aims to facilitate and accelerate the generation of robust and relevant evidence for the assessment of marketing authorisation applications for promising medicines.
In this way, the EMA hopes that patients in the EU will benefit more quickly from innovative therapies.
In particular, the EMA will propose two tools to improve the ongoing dialogue between regulators and developers. A roadmap for each PRIME product development and a PRIME product development tracker will be established.
In order to respond more quickly to requests from PRIME applicants, fast-track scientific advice may be provided for PRIME developments in case of problems with a specific development programme that has already received full initial advice. This new feature was established after a 12-month pilot project which will be conducted until March 2024 was launched.
Finally, the EMA will offer submission readiness meetings ahead of the submission of a marketing authorisation application to developers of promising medicines participating in PRIME. These meetings will be held approximately one year before the submission.
The EMA states in its analysis of the experiences over the last five years that such a meeting will also allow a more realistic evaluation of the chance for developers to obtain and maintain an accelerated assessment schedule, avoiding premature applications.
Link to the analysis and description of the new PRIME features: https://aeur.eu/f/68j (Original version in French by Émilie Vanderhulst)