The European Medicines Agency launched three new tools to support PRIME, the Agency’s scheme to enhance support for the development of medicines targeting an unmet medical need. These tools are the result of five-year analysis of PRIME and of the completion of two-year pilot to assess their effectiveness. More in details, the new tools are:
- The regulatory roadmap and product development tracker: to provide a structured, dynamic framework for monitoring medicine’s progress and flag potential issues early. It makes easier for developers and EMA to stay aligned throughout development.
- The expedited scientific advice: to deliver timely and focused regulatory input for developers on focused questions that are critical for the development process.
- The Submission Readiness Meeting: this is a dedicated check-in, about a year before marketing authorisation application, where EMA and developers discuss the progress of the programe against the plan and identify any remaining evidence gaps to ensure that a comprehensive data package is available for the evaluation by the Committee for Medicines for Human Use (CHMP).
Results from the pilot indicate that these new PRIME tools enhance regulatory agility and better support to developers and will therefore be integrated as permanent tools within the PRIME scheme.
Their introduction also come at a crucial time as EMA prepares for operation under the revised EU pharmaceutical legislation. In fact, once the new EU legislative framework comes into force, it will formally codify PRIME within its provisions.
These features reaffirm EMA’s commitment to the continuous evolution of PRIME, strengthening its operation and enhancing its ability to accelerate the availability of innovative medicines for patients with unmet medical needs.
To learn more about follow this link: New PRIME tools to accelerate development of medicines in the EU | European Medicines Agency (EMA).