Legal News

Life Sciences weekly highlights—22 July 2021

Published on: 22 July 2021
Published by: LexisPSL
  • Life Sciences weekly highlights—22 July 2021
  • In this issue:
  • Manufacture, marketing and sale
  • HTA Regulation in the EU—a blessing or a burden for market access?
  • MDCG publishes guidance on integrating UDI within quality management systems
  • Commission publishes new forms for Notified Bodies in relation to MDR and IVDR
  • Commission Implementing Decision on harmonised standards for in vitro diagnostic medical devices published in Official Journal
  • Commission Implementing Decision on harmonised standards for medical devices published in Official Journal
  • Research and development
  • MHRA highlights plan for combined review for clinical research trials
  • More...

Article summary

This week's edition of Life Sciences weekly highlights includes analysis of the provisional agreement between the Council of the EU and European Parliament on the EU Health Technology Assessment Regulation (HTA Regulation), details of the Medicines and Healthcare products Regulatory Agency (MHRA) announcing that all new Clinical Trials of Investigational Medicinal Products in the UK will be subject to a combined review from the MHRA and the UK Research Ethics Services from January 2022, and information of the Competition and Markets Authority (CMA) fining a company £260m for anticompetitive abuses with respect of the supply of hydrocortisone tablets. or take a trial to read the full analysis.

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