EMA introduces three new features for use in PRIME

The EMA has launched three new features in PRIME. These are intended to support and streamline continued scientific dialogue, give developers faster answers, and provide better support in preparation for the submission of a marketing authorisation application.

The tools are :

• a regulatory roadmap and product development tracker, which helps chart the progress of a medicinal product and flag potential issues early, making it easier for developers and EMA to stay aligned throughout development;

• expedited scientific advice, a fast‑track route for developers to receive timely and focused regulatory input on focused questions that are critical for the development process;

• a submission readiness meeting, which 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).