EMA Reflects on One Year of its PRIME Designation
A recent survey revealed that drugmakers are facing some challenges in using the European Medicines Agency’s PRIME program for priority medicines, which recently marked its one-year anniversary.
Some applicants surveyed said they were uncertain about the PRIME designation’s value, and felt it might limit their flexibility with other European regulators.
They also suggested allowing for a pre-submission meeting with the EMA on whether their product meets eligibility criteria and whether the program is right for them. But at an event held to review the program’s progress, the EMA said it would prefer to provide a scientific committee’s view rather than a simplified summary in a pre-submission meeting.