The European Medicines Agency (EMA) has launched three major new features for PRIME, a scheme supporting the development of treatments targeting unmet medical needs in the EU.
PRIME, which has completed a two-year pilot, aims to give developers faster answers and better preparation support when submitting a market authorisation application.
To help chart a medicine’s progress and flag potential issues, the EMA will add a regulatory roadmap and product development tracker. The aim of this feature is to allow developers and the EMA to align more easily throughout development.
The second tool, the expedited scientific advice, is a fast‑track route for developers to receive timely a and focused regulatory input on focused questions that are critical for the development process.
A check-in about a year before submission will be the third new feature. The submission readiness meeting involves a discussion between the EMA and developers discussing their progress and identifying any gaps, ensuring a data package is available to be evaluated by the Committee for Medicines for Human Use (CHMP).
The results of the pilot scheme come as the EMA prepares for operation under the revised EU pharmaceutical legislation, a change that will formally codify PRIME within the provisions of the new EU legislative framework.
Planned refinements to the PRIME scheme include updating guidance based on the pilot experience, providing more agile expedited scientific advice, allowing for a more flexible meeting schedule and exploring future digital solution to track real-time product development.
Michael Berntgen, the Head of Scientific Evidence Generation at EMA, said: “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.”