News - April 5, 2023

New features further strengthen EMA’s Priority Medicines scheme (PRIME)

EMA introduces 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 main objective of this voluntary scheme is the enhanced interaction and early dialogue with developers of promising medicines, to continuously optimise development plans and speed up evaluation so that earlier patient access of life-changing medicines can be achieved. The implementation of the new features follows a review of the first five years’ experience with the scheme and was accompanied by comprehensive support from trade associations and industry through regular interactions with the Agency.

Critical new features to enhance its support measures are the Regulatory Roadmap and the Product Development Tracker which aim at facilitating the continuous dialogue between regulators and developers as this integral document which is to be submitted through IRIS records both regulatory touchpoints and scientific development aspects and thereby ensures continuous monitoring and identification of issues along the development process.

Another feature benefitting the developer is the provision of expedited follow-up scientific advice (under certain criteria) with shortened timelines which will form part of a 12-month pilot until March 2024 and applies to PRIME products that have already received comprehensive initial advice and should allow to address questions in a shorter timeframe.

Finally, EMA offers a submission readiness meeting approximately one year of the marketing authorization application (MAA) for purposes of discussing the development status and dossier maturity, application type, requirements for post-marketing evidence generation and potential regulatory challenges.

Further information on all new features, the updated overall PRIME guidance, the key benefits of the PRIME scheme for developers and other useful content can be found here: EMA PRIME Scheme