EMA Enhances PRIME Scheme to Accelerate Medicine Development
Summary
The European Medicines Agency (EMA) has launched three new features for its PRIME scheme, designed to accelerate the development of medicines targeting unmet medical needs. These tools aim to streamline scientific dialogue and provide developers with faster answers and better preparation for marketing authorisation applications.
What changed
The European Medicines Agency (EMA) has officially integrated three new features into its Priority Medicines (PRIME) scheme, following a successful two-year pilot. These enhancements include a regulatory roadmap and product development tracker, an expedited scientific advice process, and a submission readiness meeting. The goal is to foster continuous scientific dialogue, identify critical issues early, and better support developers in preparing marketing authorisation applications, especially in anticipation of revised EU pharmaceutical legislation.
These new tools are now permanent features of the PRIME scheme and are intended to increase regulatory agility and provide more effective support to drug developers. Companies utilizing the PRIME scheme should familiarize themselves with these new features, particularly the submission readiness meeting which occurs approximately one year before anticipated submission. While no specific compliance deadline is mentioned for adopting these tools, their integration signifies an enhanced pathway for innovative medicines, and developers are encouraged to leverage them to ensure comprehensive data packages for evaluation by the Committee for Medicines for Human Use (CHMP).
What to do next
- Review the new PRIME features: regulatory roadmap, expedited scientific advice, and submission readiness meeting.
- Incorporate the new PRIME tools into ongoing medicine development plans and timelines.
- Prepare for the submission readiness meeting approximately one year prior to marketing authorisation application submission.
Archived snapshot
Mar 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
New PRIME tools to accelerate development of medicines in the EU
18 March 2026
Three new PRIME features streamline scientific dialogue and help developers to stay on track News Human PRIME
EMA launched three major new features of PRIME, the Agency’s scheme to enhance support for the development of medicines targeting an unmet medical need. After the completion of a two-year pilot, the Agency has integrated these additional tools to support continued scientific dialogue, giving developers faster answers and better supporting preparation for the submission of a marketing authorisation application.
The first tool, the regulatory roadmap and product development tracker, helps chart a medicine’s progress and flag potential issues early, making it easier for developers and EMA to stay aligned throughout development. The second tool, the expedited scientific advice, is a fast‑track route for developers to receive timely and focused regulatory input on focused questions that are critical for the development process. The third tool, the submission readiness meeting, is a dedicated check-in, about a year before submission, where EMA and developers discuss the progress of the programme against the plan and identify any remaining evidence gaps to ensure that a comprehensive data package is available for a thorough evaluation by the Committee for Medicines for Human Use (CHMP).
"Over the ten years since its launch, PRIME has continued to evolve to keep pace with scientific innovation and accelerate the development and assessment of innovative medicines. The new features we are now rolling out following the pilot enhance our ability to identify and address critical issues early in the development process through continuous scientific dialogue with the developer."
Head of Scientific Evidence Generation at EMA, Michael Berntgen
The results of the pilot indicate that the new PRIME features promote enhanced regulatory agility and better support to developers. They also come at a crucial time as EMA prepares for operation under the revised EU pharmaceutical legislation. In fact, when the new EU legislative framework comes into force, it will formally codify PRIME within its provisions.
EMA will integrate all three features as permanent PRIME tools. Planned refinements include updated guidance based on the pilot experience, more agile expedited scientific advice, more flexible meeting scheduling, and exploration of future digital solutions for real-time product development tracking. At the same time, EMA is exploring the new concept of an EMA Product Development Coordination as primary point of contact for the developer to facilitate better support through the medicine’s development.
Related documents
Progressing EMA’s PRIority Medicines scheme through new pilot features
English (EN) (1.48 MB - PDF)
First published:
18/03/2026
Related content
- PRIME: priority medicines
- Research and development
- Scientific advice and protocol assistance
- Reform of the EU pharmaceutical legislation
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