Collection

MHRA innovation case studies

Case studies showing how the MHRA helped several companies to navigate regulatory processes for launching innovative new medicines and medical devices

• From: Medicines and Healthcare products Regulatory Agency
• Published: 31 July 2015
• Last updated: 15 July 2022 — See all updates

See how MHRA worked together with companies to help them understand and fulfil the regulatory requirements of launching innovative medical products.

Contact the Innovation Office to see how we can help you.

Documents

• Horizon Scanning Case Study: Point of Care manufacture
  • 15 July 2022
  • Case study
• Early Access continues during the coronavirus (COVID-19) pandemic
  • 6 April 2021
  • Case study
• Innovation: MHRA’s speedy approval of high dose flu vaccine demonstrates flexibilities in national applications
  • 16 March 2020
  • Case study
• Innovation: Clonal neoantigen specific tumour-infiltrating lymphocytes for cancer treatment
  • 29 January 2020
  • Case study
• Innovation: Queen’s University Belfast
  • 12 July 2016
  • Case study
• Innovation: over 500 UK patients gain early access to new skin cancer treatment
  • 17 December 2015
  • Case study
• Innovation: MHRA advises the Cell Therapy Catapult of regulatory requirements
  • 31 July 2015
  • Case study
• Innovation: MHRA helps Fujifilm future proof manufacturing facility - one of the first in Europe
  • 25 June 2015
  • Case study
• Innovation: early dialogue with MHRA shapes development of UK manufacturing site
  • 26 March 2015
  • Case study
• Innovation: MHRA supports innovative vaccine development at the University of Oxford
  • 3 March 2015
  • Case study
• Innovation: MHRA helps Eisai with state-of-the-art facility
  • 29 January 2015
  • Case study
• Innovation: MHRA helps OxSonics early on
  • 30 December 2014
  • Case study
• Innovation: MHRA gives AstraZeneca early advice
  • 5 December 2014
  • Case study

Published 31 July 2015
Last updated 15 July 2022 + show all updates

1. 15 July 2022

   Added 'Horizon Scanning Case Study: Point of Care manufacture' to the collection.

2. 6 April 2021

   Added 'Early Access continues during the coronavirus pandemic' to the list of innovation case studies.

3. 19 February 2020

   'MHRA’s speedy approval of high dose flu vaccine demonstrates flexibilities in national applications' case study added to collection.

4. 17 December 2015

   New case study out now: Innovation: Over 500 UK patients gain early access to new skin cancer treatment

5. 31 July 2015

   First published.