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UK and EU life sciences developments—7 August 2025: NICE–MHRA alignment, MHRA Early Access for devices, clinical trials reforms, Moderna v Pfizer, EHDS and EMA pharmacovigilance updates

Published on: 07 August 2025

Published by a LexisNexis Life Sciences expert
Legal News
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  • Pharmaceuticals—regulatory framework
  • Research and development
  • Medical devices
  • Intellectual property
  • Post-market
  • Data protection and life sciences
  • Advertising of medicines
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Pharmaceuticals—regulatory framework

NICE and MHRA to align under 10‑Year Health Plan, speeding access to medicines

The National Institute for Health and Care Excellence (NICE) and the Medicines and Healthcare products Regulatory Agency (MHRA) have established a joint information‑sharing arrangement to hasten NHS patients’ access to new medicines in England. As a component of the government’s 10‑Year Health Plan for England, pharmaceutical companies are invited to engage early with both organisations to facilitate parallel decisions on licensing and value. The agencies indicate this joined‑up route should see medicines ready for NHS use at the point they obtain a UK licence, with access times expected to fall by three to six months. To access the service, companies should list products on UK PharmaScan, the national horizon scanning database, at least three years before the projected marketing authorisation date. The initiative forms part...

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