The European Medicines Agency's (EMA) PRIority Medicines (PRIME) scheme is designed to expedite the development of promising treatments for unmet medical needs. After reviewing its first five years, EMA has introduced several enhancements to further optimize and streamline the PRIME process, providing enhanced support to developers and accelerating patient access to innovative therapies.
Key takeaways
- The new Regulatory Roadmap and Product Development Tracker foster continuous dialogue, enabling real-time monitoring, issue identification, and proactive problem-solving.
- A pilot program allows developers to seek expedited scientific advice, addressing urgent queries promptly outside standard timelines.
- Submission readiness meetings, held around one year pre-submission, provide an opportunity to assess development status, tackle challenges, and ensure preparedness.
- These additions aim to improve communication, facilitate efficient evidence generation, and ensure regulatory alignment throughout development.
To learn more about the latest enhancements to the PRIME scheme and how they can benefit your drug development program, read the full white paper.
