Frontiers in Medicine (Dec 2022)

Regulatory policy and pharmaceutical innovation in the United Kingdom after Brexit: Initial insights

  • Matthias P. Hofer,
  • Paola Criscuolo,
  • Nilay Shah,
  • Anne L. J. ter Wal,
  • James Barlow

DOI
https://doi.org/10.3389/fmed.2022.1011082
Journal volume & issue
Vol. 9

Abstract

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Brexit was presented as an opportunity to promote innovation by breaking free from the European Union regulatory framework. Since the beginning of 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) has operated as the independent regulatory agency for the United Kingdom. The MHRA's regulatory activity in 2021 was analyzed and compared to that of other international regulatory bodies. The MHRA remained reliant on EU regulatory decision-making for novel medicines and there were significant regulatory delays for a small number of novel medicines in the UK, the reasons being so far unclear. In addition, the MHRA introduced innovation initiatives, which show early promise for quicker authorization of innovative medicines for cancer and other areas of unmet need. Longer-term observation and analysis is needed to show the full impact of post-Brexit pharmaceutical regulatory policy.

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