Report on the experience with the new PRIME features following the 5-year review of the scheme to support the development of medicines targeting unmet needs
This report presents the findings from a two-year pilot (April 2023–March 2025) to assess the effectiveness of the new features in supporting PRIME product development, and to understand the experiences and perceptions of regulators and PRIME developers as support tools.
The report integrates quantitative analyses of submissions and feedback from PRIME developers and regulatory assessors from the European medicines regulatory network (EMRN).