Regulatory policy and pharmaceutical innovation in the United Kingdom after Brexit: initial insights
File(s)
Published version
Author(s)
Hofer, Matthias
Criscuolo, Paola
Shah, Nilay
ter Wal, Anne
Barlow, James
Type
Journal Article
Abstract
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.
Date Issued
2022-12-15
Date Acceptance
2022-11-23
Citation
Frontiers in Medicine, 2022, 9
ISSN
2296-858X
Publisher
Frontiers Media
Journal / Book Title
Frontiers in Medicine
Volume
9
Copyright Statement
© 2022 Hofer, Criscuolo, Shah, Wal and Barlow. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
License URL
Publication Status
Published
Article Number
ARTN 1011082