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

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

JOURNAL=Frontiers in Medicine

VOLUME=Volume 9 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.1011082

DOI=10.3389/fmed.2022.1011082

ISSN=2296-858X

ABSTRACT=Brexit was presented as an opportunity to promote innovation by breaking free from the European Union regulatory framework for medical technologies. Since the beginning of 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) operates as the stand-alone and independent regulatory agency for the United Kingdom. 
MHRA remained reliant on EU regulatory decision-making in its first year of independence, especially for novel medicines. 
MHRA introduced innovation initiatives, which show early promise for quicker authorization of innovative medicines for cancer and other areas of unmet need 
There is preliminary evidence for significant regulatory delays for a small number of novel medicines in 2021 compared to other international regulatory bodies
Longer-term observation and analysis will be needed to show the full impact of post-Brexit pharmaceutical regulatory policy