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…
