New features further strengthen Priority Medicines scheme (PRIME)

EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to strengthen its support for the development of medicines in areas of unmet medical needs. The PRIME scheme enables earlier availability of life-changing medicines for patients. By the end of 2022, 26 medicines that benefited from PRIME support had received a positive recommendation for approval in the European Union (EU). 

The implementation of the new features follows a review of the first five years’ experience with the scheme, which highlighted some opportunities for further strengthening the scheme.

To optimise the early scientific and regulatory support provided to promising medicines, a roadmap for each PRIME development alongside a product development tracker will be established. Both tools will facilitate the continuous dialogue between regulators and developers as the progress of the development is continuously monitored and as critical aspects for further discussion can be identified throughout the development process.

Starting as a 12-month pilot until March 2024, expedited scientific advice can now be provided specifically for PRIME developments in case of issues with a specific development programme that has already received comprehensive initial advice. This agile setting for scientific advice will allow to address queries from PRIME applicants in a shorter timeframe.

The final new feature is represented by submission readiness meetings, which will be held approximately one year ahead of the submission of a marketing authorisation application with developers of PRIME medicines. The scope of these meetings is to discuss the status of the development including the implementation of previous regulatory advice, and the resulting data package intended to support the marketing authorisation application. Prospective applicants would also be expected to present mature plans for post-marketing evidence generation, as applicable.

All these initiatives aim to facilitate and accelerate the generation of robust and relevant evidence for the evaluation of a marketing authorisation application, which will give patients earlier access to transformative treatments that can make a real difference.

Background on the five-year analysis

EMA published a report presenting results from the first five years of PRIME in March 2022. It looked at how the scheme helped developers prepare for marketing authorisation assessments. This report showed that the PRIME scheme has had a positive impact on the authorisation of new medicines that benefit patients with no current treatment options for their disease or offer a major therapeutic advantage over existing treatments. It also called for further enhancement, including increasing the flexibility of scientific advice provision, and helping applicants better prepare for the marketing authorisation assessment phase.