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United Kingdom

UK and EU life sciences: MHRA/NICE approval reforms; EMA/HMA ATMP warning; MDR/IVDR conditional certificates; CMA tech transfer exemption consultation; DHSC branded pricing rises; High Court confidentiality judgment

Published on: 20 March 2025

Published by a LexisNexis Life Sciences expert
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Advanced therapeutics

MHRA and NICE announce joint regulatory reforms to speed up medicine approvals

On 17 March 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) set out revised regulatory pathways as part of broader government changes. From July 2025, the MHRA will allow point-of-care production of personalised therapies, and NICE targets completing 60% of technology appraisals within 240 working days in 2025/26. The bodies will introduce a joined-up scientific advice offer and run marketing authorisation and technology appraisal in parallel to shorten timelines for new medicines. See: LNB News 18/03/2025 38.

EMA and HMA issue joint warning on illegal advanced therapy medicines

On 13 March 2025, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a joint alert about unregulated advanced therapy medicinal products (ATMPs) available within the EU. They underline that ATMPs may lawfully be provided solely via central EMA authorisation, approved clinical trials, or defined exemptions granted by national authorities...

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