The European Medicines Agency (EMA) has published the 2027 deadlines for submitting PRIME eligibility requests and the corresponding timetable for assessment, in a document dated 9 July 2026. The schedule outlines 11 submission cut-off dates throughout 2027, each followed by a procedure start at a Scientific Advice Working Party (SAWP) meeting, a SAWP recommendation, a Committee for Advanced Therapies (CAT) recommendation for advanced therapy medicinal products, and final adoption by the Committee for Medicinal Products for Human Use (CHMP).
The first deadline is 6 January 2027, with the procedure starting at the SAWP meeting of 11–14 January, a SAWP recommendation by 11 February, CAT recommendation (if applicable) by 19 February, and CHMP adoption by 25 February. Subsequent deadlines are spaced roughly monthly, with the last submission on 24 November 2027, leading to a SAWP meeting of 29 November–2 December, SAWP recommendation by 13 January 2028, CAT recommendation by 21 January 2028, and CHMP adoption by 27 January 2028.
PRIME (Priority Medicines) is EMA's scheme to enhance support for the development of medicines that target an unmet medical need. The timetable is intended to help applicants plan their submissions. The document, issued by EMA's Human Medicines Division, applies to all PRIME eligibility requests submitted in 2027. No prior coverage of this timetable exists in the available record.
Stakeholders most impacted include pharmaceutical companies developing innovative therapies, who must align their submission timelines with these cut-off dates to benefit from accelerated assessment. The schedule provides predictability but imposes strict deadlines that may require earlier preparation. Patient groups and healthcare systems may indirectly benefit from faster access to promising treatments if PRIME-designated medicines reach the market sooner. EMA's own committees (SAWP, CAT, CHMP) will need to manage their workload to adhere to the assessment milestones.