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…