Expert comment: EMA to strengthen the PRIME scheme with three new features

On 18 March 2026, the European Medicines Agency (EMA) published its plans to implement three new PRIME scheme features following a successful two-year pilot. These 3 new pilot features had been launched in April 2023 to fulfil recommendations for improvement of the PRIority Medicines (PRIME) scheme after reviewing the first 5 years of experience.

These three new features – the regulatory roadmap and product development tracker, the expedited scientific advice procedure, and the submission readiness meeting (SRM) – were selected for regular implementation into the existing PRIME scheme to fill persistent gaps, which include limited continuity of regulatory dialogue between key milestones,  insufficient flexibility/agility in scientific advice, and inadequate preparedness of marketing authorisation applications (MAAs) for accelerated assessment.

1. Regulatory roadmap & product development tracker

The first tool is a combined regulatory roadmap and development tracker to provide a structured, dynamic framework for monitoring product development, replacing the annual update with more targeted, issue-focused information. The tool enables both developers and the EMA to remain more closely aligned throughout the development process and to identify issues early.

During the trial period, regulators found it effective for tracking critical development issues and preparing for kick-off meetings and SRMs. Developers, however, experienced difficulties with the format and the perceived high administrative burden, especially for smaller companies. Key recommendations for improvement include to restructure and simplify the tracker format, improve guidelines, establish systematic Rapporteur feedback, and to progress towards greater interoperability and an integrated digital solution enabling real-time tracking of development progress and associated regulatory interactions.

2. Expedited scientific advice

The second tool – expedited scientific advice – introduces a flexible and accelerated scientific advice (SA) procedure for PRIME products for issues linked to previously discussed development programmes (previously defined as follow-up scientific advice), provided the scope is clearly defined and the advice is required more urgently than the standard scientific advice timelines allow. In the pilot, developers valued the expedited scientific advice but requested broader access criteria and faster turnaround time. Key recommendations for improvement include  to expand the eligible scenarios to include issues arising during kick-off meetings and SRMs, to clarify guidelines on eligibility criteria, and to explore mechanisms to reduce evaluation time.

3. Submission Readiness Meeting

The third tool – the Submission Readiness Meeting (SRM) – was introduced to address the finding that half of PRIME MAAs that initially targeted accelerated assessment reverted to standard timelines, often due to incomplete implementation of Scientific Advice or due to incomplete data packages. The SRM therefore provides an opportunity at a time point closer to the MAA filing date (9-12 months) to discuss with the Rapporteur team, CHMP/CAT leadership, EMA committee and SAWP representatives, and the EMA product team, about the development status of the PRIME product concerned, including whether previous regulatory advice for key development areas was implemented and whether the resulting data package intended to support the MAA is sufficiently mature. Both developers and regulators responded positively to the SRMs.

Of the five products that reached MAA submission following a SRM during the trial period, two were granted marketing authorisation under accelerated assessment and one under standard timelines. Key recommendations for improvement include strengthening the focus on scientific advice implementation, dossier maturity, and accelerated assessment eligibility, systematically include, for concerned products, discussions on orphan designation, GCP/GMP readiness, and PIP compliance, and establish expedited scientific advice as the default follow-up for outstanding SRM issues.

Closing remarks

The integration of these new pilot features as standard PRIME tools, and the recommendations for their further refinement following the outcome of the 2-year pilot, will continue enhancing the dialogue between the medicine developers, the EMA, and the Rapporteur teams, thus reconfirming the EMA’s commitment towards accelerating the availability of innovative medicines to patients with unmet medical needs.