In 2016, the European Medicines Agency (EMA) launched the PRIority MEdicines (PRIME) scheme to provide early scientific and regulatory support for cutting-edge therapies with the potential to address unmet medical needs. Accelerating time-to-market enables patients to receive access to these types of medicines earlier, which can make a huge impact on their health and quality of life.
During the first 5 years of the program, PRIME has accelerated the authorization of the first CAR T-cell therapies, vaccines, as well as novel gene therapies and cancer treatments. Recently, EMA has published a report analyzing the first years of the PRIME scheme, and the report shows that the program has made a positive impact. The report also identifies key areas for improvement and provides recommendations for optimizing PRIME to benefit even more patients in the future.