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 EMA has integrated these additional tools to support continued scientific dialogue, aiming to give developers faster answers and better support 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 the 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 the 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). 

Head of Scientific Evidence Generation at the EMA, Michael Berntgen, commented: “Over the 10 years since its launch, PRIME has continued to evolve to keep pace with scientific innovation and accelerate the development and assessment of innovative medicines. The new features we are now rolling out following the pilot enhance our ability to identify and address critical issues early in the development process through continuous scientific dialogue with the developer.” 

The EMA says 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 the EMA prepares for operation under the revised EU pharmaceutical legislation. 

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