CRED ERP 25

01/07/2025

EMA report on 5 year PRIME in 2022

• EMA published on 3 March 20202 a report evaluating 5 year PRIME from March 2016 (Start PRIME) – June 2021 • 18 medicines that had PRIME support were approved in the European Union (EU) of which 10 received a conditional MA

• 7 were ATMP, 16 concern rare diseases

• Positive conclusion (PRIME enables earlier availability of life changing medicines) plus recommendations for improvement NB: In December 2021 PRIME elegibility granted to the first academia-led development!

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Rolling review (e.g. Covid vaccins)

• During the pandemic in 2020 and 2021: rolling reviews were introduced for e.g. assessment Covid-19 vaccines • Evaluation of advantages and disadvantages has taken place and is also included in new proposal pharmaceutical legislation

NB: New proposed legislation includes proposals for “rolling reviews” under specific conditions

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