EMA updates the PRIME pathway with roadmaps :
• To improve its PRIority MEdicines (PRIME) program, which aims to hasten the development of medicines for unmet needs, the European Medicines Agency (EMA) has taken recommendations from a recent report. The modifications include making sure that drug sponsors and regulators agree on the process and deadlines for getting the medicine through review.
• In order to give businesses creating medications for unmet medical needs more opportunity to interact with regulators, EMA introduced the pathway in 2016.
• The roadmap and tracker will take the role of the PRIME yearly update beginning in March 2023 as a pilot program for any items that have not previously been covered in a Kick-off meeting.
• The regulatory roadmap and development tracker, which contains details on anticipated regulatory filings and contacts with regulators, must be kept up to date and maintained by applicants as per EMA requirements.
• The revised guidance now permits submission preparedness meetings, which will be set up about a year before the applicant files their application for a marketing authorization.
Potential applicants would also be required to provide developed strategies for the generation of post-marketing proof, where appropriate.
• In order to arrange a submission readiness meeting with the PRIME Rapporteur and the assessment team, pertinent national experts, and the EMA product team, applicants are urged to get in touch with their PRIME scientific coordinator about 15 months prior to when they anticipate submitting their applications. The framework of the meeting will be the same as the kick-off meeting, but candidates will have an earlier opportunity to discuss what needs to be done before they submit their applications.
• The guidance indicates that in this situation, applicants “should consider that, to the extent feasible, the [submission] package should include all necessary data needed to support the intended [marketing application authorization (MAA)].” “This should take into account the possibility that applications for conditional marketing authorizations or marketing authorizations under unusual circumstances may not require as much evidence. At this time, applicants would also be required to demonstrate developed strategies for the creation of post-marketing evidence, as appropriate.
PRIME Eligibility requests Flowcharts:
PRIME: Areas Of Unmet Need
Outcome Of PRIME Eligibility Requests:
Outcome Of PRIME Eligibility Requests Per Therapeutic Area:
Orphan Outcome Through PRIME: Outcome Of PRIME Eligibility Requests For Orphan and Non-Orphan Medical Products:
European Medicines Agency guidance for applicants seeking access to PRIME scheme (europa.eu)