EMA launches three new priority medicines tools to support medicine development
The European Medicines Agency (EMA) has launched three new features under its priority medicines (PRIME) scheme, following a two-year pilot, to enhance support for medicines targeting unmet medical needs. The features—a regulatory roadmap and product development tracker, expedited scientific advice, and a submission readiness meeting—aim to streamline scientific dialogue, provide faster responses, and help developers prepare for marketing authorisation applications. The EMA has indicated that these tools will become permanent PRIME features as it prepares for the revised EU pharmaceutical legislation.