EMA strengthens PRIME scheme with new features
The European Medicines Agency (EMA) has announced a number of new features which will be added to the Priority Medicines scheme (PRIME). These new features are meant to enhance PRIME’s support for the development of medicines in areas of unmet medical need, ensuring patients continue to benefit as early as possible from potentially life-changing treatment. They are:
- Establishment of tools which facilitate continuous dialogue between regulators and developers, to optimise early scientific and regulatory support;
- PRIME-specific expedited scientific advice, as part of the 12-month pilot launched in March 2023;
- Submission readiness meetings, held with developers approximately one year before submitting a marketing authorisation application to discuss the status of the development.
Launched in 2016, the PRIME scheme provides developers with access to a number of services to help optimise the generation of robust data on drug benefits and risk, as well as an accelerated assessment of medicines applications. It builds on the existing regulatory framework to better address conditions for which no treatment option currently exists. Many rare diseases fall into this category, and as such the new features have significant implications for rare disease drug development. As of the end of 2022, 26 medicines that benefited from PRIME support had received a positive recommendation for approval from the EMA’s Committee for Human Medicinal Products.
The enhancements to PRIME are being introduced following the publication of the scheme’s 5-year evaluation in March 2022. Despite finding that PRIME had an overall positive impact on the authorisation of new medicines which fulfilled unmet medical needs, it also identified potential areas for enhancement. These included making the provision of scientific advice more flexible, and strengthening support for preparing for the marketing authorisation assessment phase.
In order to help drug developers navigate the new features, the EMA has updated their guidance document for applicants seeking PRIME access.
