Clinical Trials, Medicinal Product Licensing, and Early Patient Access Pathways

The UK formally left the EU on 31 January 2020, followed by an 11-month transition period which ended on 31 December 2020. On 01 January 2021, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) became a standalone national authority. However, as a result of the Northern Ireland protocol, Northern Ireland will continue to follow the EU regulatory framework.

The MHRA has released guidelines explaining how clinical trials, licensing of medicinal products, importing, and exporting will be regulated from 01 January 2021. The new MHRA guidelines remain closely aligned with the EU regulatory framework but include a number of changes. To help sponsors prepare for the changes, PRA’s Regulatory Strategy & Agency Liaison (RSAL) team have assessed the new MHRA guidelines and have highlighted the following major areas in this white paper:

  • Clinical trials
  • Pediatric investigation plans
  • Licensing of medicinal products
  • Early patient access
  • Orphan medicinal products
  • Importing and exporting

The RSAL team can advise and partner with sponsors throughout the new MHRA regulatory process, and we strongly encourage sponsors to pay close attention to the upcoming new guidance that will be released by the MHRA.

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