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1. PRIME scheme: The European Medicines Agency (EMA) has a priority medicines scheme called PRIME, which aims to support the development of medicines that address unmet medical needs. This scheme provides early and enhanced support to medicine developers, including scientific advice and accelerated assessment.

2. Guidance for applicants: The EMA has published guidance for applicants seeking access to the PRIME scheme. This document outlines the eligibility criteria, application process, and benefits of the scheme. It also provides information on how to prepare for the kick-off meeting and submission readiness meeting.

3. Regulatory roadmap: The EMA has developed a regulatory roadmap and product development tracker for medicines in the PRIME scheme. This document helps medicine developers navigate the regulatory process and track their progress towards approval.

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