Module 6

04 October 2024

Early support – PRIME designation (3)

Features of the PRIME scheme

Early access tool, supporting patient access to innovative medicines.

▪ Written confirmation of PRIME eligibility and potential for accelerated assessment ;

▪ Early CHMP Rapporteur appointment during development;

▪ Kick off meeting with multidisciplinary expertise from EU network;

▪ Enhanced scientific advice at key development milestones/decision points;

▪ EMA dedicated contact point ;

▪ Fee incentives for Small and medium-sized enterprises (SMEs) and academics on Scientific Advice (SA) requests.

In 2023 three PRIME-designated medicines were recommended for approval: Casgevy, Elrexfio and Talvey.

An Agency perspective: the success and failure of a medicinal product in the EU

24

Classified as public by the European Medicines Agency

24

Applicant Legal Basis

An Agency perspective: the success and failure of a medicinal product in the EU

25

Classified as public by the European Medicines Agency

25

13