EMA accelerates Development of Medicines

The European Medicines Agency (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. After 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 authorization application.

PRIME - EMA’s PRIority MEdicines Scheme

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. It includes the following three tools:

• Regulatory roadmap and product development tracker. It helps chart a medicine’s progress and flag potential issues early, making it easier for developers and EMA to stay aligned throughout development.
• Expedited scientific advice. A fast-track route for developers to receive timely and focused regulatory input on focused questions that are critical for the development process.
• Submission readiness meeting. 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).

For more information please see Progressing EMA’s PRIority Medicines scheme through new pilot features.