PRIority MEdicines (PRIME) is a scheme run by the EMA to enhance support for the development of medicines targeting unmet medical needs. It is based on early dialogue with companies to optimise development plans and speed up evaluation.
EMA has launched three major new features of PRIME, the Agency’s scheme to enhance support for the development of medicines targeting an unmet medical need.
- Following the completion of a two-year pilot, the Agency has integrated these additional tools to support continued scientific dialogue, giving developers faster answers and better supporting preparation for the submission of a marketing authorisation application.
- The first tool, the regulatory roadmap and product development tracker, helps chart a medicine’s progress and flag potential issues early, making it easier for developers and EMA to stay aligned throughout development.
- The second tool, the expedited scientific advice, is a fast‑track route for developers to receive timely and focused regulatory input on focused questions that are critical for the development process.
- The third tool, the submission readiness meeting, 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).
The results of the pilot indicate that the new PRIME features promote enhanced regulatory agility and better support to developers.
- They also come at a crucial time as EMA prepares for operation under the revised EU pharmaceutical legislation.
- In fact, when the new EU legislative framework comes into force, it will formally codify PRIME within its provisions.
You can find out more about the tools in the report Progressing EMA’s PRIority Medicines scheme through new pilot features.
Source: EMA