EMA updates PRIME pathway with roadmaps, scientific advice pilot

The European Medicines Agency (EMA) has incorporated recommendations from a recent report to enhance its PRIority MEdicines (PRIME) scheme, which is meant to speed the development of drugs for unmet needs. The changes include ensuring there’s an agreement between drug sponsors and regulators about the pathway and timelines for getting the drug through the review process.

EMA launched the pathway in 2016 to help companies developing drugs for unmet needs to have more opportunities to engage with regulators.

Last year, EMA published a report looking back at five years of the new pathway and lessons learned from it. The report made a number of recommendations that the agency has incorporated into the PRIME scheme including a roadmap that can be used alongside a product development tracker to track the product’s progress. (RELATED: EMA lauds PRIME priority meds scheme and outlines potential revisions, Regulatory Focus 8 March 2022; Drug industry says EMA’s PRIME scheme useful but could be improved, Regulatory Focus 14 March 2022)

“Following the recommendations of the PRIME 5-year analysis to improve knowledge building to support accelerated assessment, and to support the Rapporteur team in their assessment work, the development progress of products entering the PRIME scheme is monitored through the submission and maintenance of a regulatory roadmap and product development tracker,” the updated guidance states. “Starting as a pilot from March 2023, the roadmap and tracker will replace the PRIME annual update for any products that have not yet been discussed in a Kick-off meeting.”

Applicants are required by EMA to maintain and update the regulatory roadmap and development tracker which includes information on planned regulatory submissions and interactions with regulators. The agency said it will help PRIME Rapporteur delegations and relevant agency experts about what is not just happening with the product but what the next planned steps are.

“Both tools will inform on the development progress and help to identify topics warranting further discussion with regulators,” the guidances states. “The roadmap includes plans for scientific advice/protocol assistance requests and other regulatory interactions, and should take into account feedback received from regulators.”

“The development tracker aims to facilitate effective and efficient tracking of critical development aspects which may be identified during the Kick-off meeting activities or may arise during subsequent development,” the agency added.

EMA is also piloting a scientific advice program through the PRIME scheme until March 2023. If certain requirements are met, applicants can ask the agency experts for scientific advice, which should first be discussed with the PRIME Scientific Coordinator, who will consider the issue with other key agency experts. They may then give a direct response to the question, ask the applicant to submit an expedited scientific advice application, or ask for a standard follow-up scientific advice application.

EMA said the scientific advice pilot program is meant to help significantly expedited the ability of sponsors to get answers to key queries from the agency in a faster timeframe.

The updated guidance allows for submission readiness meetings now as well, which will be scheduled approximately a year before the applicant submits their marketing authorization application.

“The scope 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,” said EMA. “Prospective applicants would also be expected to present mature plans for post-marketing evidence generation, as applicable.”

Applicants are asked to contact their PRIME scientific coordinator about 15 months before their expected application submission date to set up a submission readiness meeting with the PRIME Rapporteur and the assessment team, relevant national experts, as well as the EMA product team. The meeting format will be the same as the kick-off meeting but will give applicants an earlier chance to talk about what requirements need to be met before they submit their applications.

“In this context, applicants should consider that, insofar as possible, the [submission] package should include all relevant data needed to support the intended [marketing application authorization (MAA)],” the guidance states. “This should take into account that the level of evidence may be less comprehensive for applications for conditional marketing authorizations or marketing authorizations under exceptional circumstances. At this point in time, applicants would also be expected to present mature plans for post-marketing evidence generation, as applicable.”

EMA updates PRIME pathway with roadmaps, scientific advice pilot

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