The European Medicines Agency (EMA) is introducing a number of new features to the PRIority MEdicines (PRIME) scheme to strengthen its support for the development of medicines in areas of unmet medical needs.
This scheme is based on enhanced interactions and early dialogue with developers of promising medicines, to optimize development plans and speed up evaluation so these medicines can reach patients earlier. By the end of 2022, 26 medicines that benefited from PRIME had received a positive recommendation for approval in the European Union.
It presents the key benefits for applicants such as kick-off meeting with a multidisciplinary group of experts from EMA, interactive scientific advice on overall development plans or confirmation of potential accelerated assessment, among others.
To be accepted for PRIME, a medicine must demonstrate the potential to address an unmet medical need to a significant extent. This could mean introducing new methods of therapy or improving already existing ones. To justify their potential, applicants must provide data showing a meaningful improvement of clinical outcomes, such as impacting prevention, onset, or duration of a condition, or improving morbidity or mortality.
New features to be introduced
To optimize the scientific and regulatory support for promising drugs, two tools will be developed. Firstly, a roadmap will be created for each PRIME project. Secondly, a product development tracking tool will also be implemented. Both of these tools will facilitate the continuous dialogue between regulators and applicants as the progress of their medicinal products is continuously monitored. By using these tools, critical aspects can be identified throughout the development process.
Starting now with a 12-month pilot until March 2024, expedited scientific advice with shortened timelines can now be provided specifically for PRIME developers. This is a significant development that will benefit PRIME developers in case of issues with a specific development programme that has already received comprehensive initial advice. This new format for scientific advice will allow regulators to address queries from PRIME applicants in a shorter timeframe if certain criteria are met.
Submission readiness meetings
Additionally, the submission readiness meetings will be held approximately one year ahead of the submission of a marketing authorization application by developers of PRIME medicines. The purpose of these meetings is to discuss the status of the development, including the implementation of previous regulatory advice, and the resulting data package intended to support the marketing authorization application. Prospective applicants would also be expected to present mature plans for post-marketing evidence generation when applicable.
Initiatives aim to speed up evidence generation for marketing applications, giving patients faster access to life-changing treatments.
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