Hits, Misses & Key Firsts For EMA’s PRIME Scheme

The rate at which investigational drugs were accepted onto the European Medicines Agency’s priority medicines scheme dropped in 2021. Meanwhile, more much-needed treatments that had been developed under the scheme went on to win EU marketing approval.

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Advanced therapies are among the candidates on the PRIME scheme • Source: Alamy

The number of investigational drugs that the European Medicines Agency accepted onto PRIME, its scheme for medicines that have the potential to address unmet medical needs, dropped sharply in 2021. Just 14 products secured a much-coveted place on the scheme.

The rate at which products were being accepted onto PRIME had been rising gradually in recent years, from 23% of applications in 2018 to 33% in 2020, when 20 drugs were

Meanwhile, medicines developed under the scheme continued to win pan-EU marketing

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