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Clinical Trials Post Brexit

05 July 2018

Brexit

AUTHOR: Nick Littlebury



Breaking comment and opinion from the BIA and MHRA Conference 2018
Royal College of General Practitioners, London 5th July 2018

Dr Martyn Ward, Head of Clinical Trials Unit, MHRA

  • Clinical trial application numbers have remained steady since the Brexit referendum.
  • The UK and Spain remain the most attractive countries for conducting Gene and Cell Therapy clinical trials.
  • It is anticipated that a streamlined CTA process with shorter timelines compared to the EU could be feasible post-Brexit if the UK is outside the network. This would partly be due to the lack of time needed for collaboration within the EU network.
  • The UK is commited to providing a new UK database and systems if no deal is agreed with the EU. Contingency plans are in place right now to redevelop IRAS (Integrated Research Application System).
  • In a conversation with the Lords one month, ago it was stated that the UK will implement the new Clinical Trial Regulation.
  • A co-assessment between MHRA and Ethics with a single application and a single opinion is planned.
  • A Pilot was started in April 2018 and the MHRA is dedicated to a future in which timelines are improved and joined-up thinking is key.
05 July 2018

Brexit

AUTHOR: Nick Littlebury