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United Kingdom

UK and EU life sciences briefing: clinical trials reforms; GB medical devices; NICE inequality methods; Samsung v Alexion; EMA Policy 0070 and ESMP; EFPIA on supply; Pandemic Agreement

Published on: 22 May 2025

Published by a LexisNexis Life Sciences expert
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In this issue:

  • Research and development
  • IP
  • Pharmaceuticals—regulatory framework
  • Advertising of medicines
  • Commercialisation
  • Medical devices
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Research and development

New Clinical Trials Regulations will bring UK closer to EU regime

Rory Trust, director, and Fraser Campbell, trainee solicitor at Burges Salmon LLP, review the incoming UK Clinical Trials Regulations set to commence in 2026, also contrasting the UK and EU clinical trial frameworks, among other aspects. The legislation has now been enacted and, following a 12-month implementation window, will apply from April 2026. It represents the most substantial overhaul of UK clinical trial rules in two decades. See News Analysis: New Clinical Trials Regulations will bring UK closer to EU regime.

MHRA launches major clinical trials overhaul, real-world data consultation and Inclusion and Diversity Plan pilot

The Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled the most far-reaching refresh of the UK’s clinical trials regulatory landscape in over twenty years, timed to coincide with International Clinical Trials Day...

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