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UK and EU life sciences regulatory update: EMA strategy, variations and device advice; MDR/IVDR burdens; MHRA decentralised manufacture; EHDS guidance; Lords scaling inquiry; NICE HST routing (27 March 2025)

Published on: 27 March 2025

Published by a LexisNexis Life Sciences expert
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In this issue:

  • Pharmaceuticals—regulatory framework
  • Medical devices
  • Data protection and life sciences
  • Research and development
  • Commercialisation
  • Daily and weekly news alerts
  • New and updated content
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EMA publishes strategy through 2028

On 18 March 2025, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) released their joint EU medicines agencies’ network strategy to 2028. It sets six priorities, including adoption of AI, progress in regulatory science and action on antimicrobial resistance. Consultation feedback questioned the network’s capacity to deliver; nevertheless, 19 of 24 submissions backed the plan, while two trade bodies were neutral. The blueprint targets post-pandemic pressures and readiness for forthcoming pharmaceutical law reforms, with a focus on the EU’s competitiveness in developing and manufacturing medicines. See: LNB News 24/03/2025 18.

Commission opens consultation on new Life Sciences strategy

The European Commission has opened a call for evidence on its planned Life Sciences strategy. The initiative seeks to reinforce the EU’s position in the life sciences by speeding up development and commercialisation of innovation. The Commission notes that, although the EU has long been strong in Life Sciences, it is losing ground to global competitors...

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