EMA launches three new tools in ‘PRIME’ scheme
The European Medicines Agency (EMA) has 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 support when preparing marketing authorisation applications.
- 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 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 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).
‘The new features we are now rolling out enhance our ability to identify and address critical issues early in the development process through continuous scientific dialogue with the developer,’ said Michael Berntgen, Head of Scientific Evidence Generation at the EMA.
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 which will formally codify PRIME within its provisions.
