THE IMPACT OF BREXIT ON PHARMACEUTICAL REGULATION AND APPROVAL IN THE UK
Author(s)
Mariama Jallow, MSc1, Phillip O'Neill, MBA2, Matthias Hofer, PhD2, James Barlow, Prof3, Mireia Jofre-Bonet, PhD2.
1London School of Economics and Political Science, London, United Kingdom, 2Office of Health Economics, London, United Kingdom, 3Imperial College London, London, United Kingdom.
1London School of Economics and Political Science, London, United Kingdom, 2Office of Health Economics, London, United Kingdom, 3Imperial College London, London, United Kingdom.
OBJECTIVES: The United Kingdom’s (UK) withdrawal from the European Union (EU) resulted in a full separation from EU pharmaceutical regulatory decision‑making, including the European Medicines Agency (EMA) and decentralised procedures. It created uncertainty and resource constraints for the UK Medicines and Healthcare products Regulatory Agency (MHRA), while opening scope for a more autonomous, innovation‑focussed framework. Longer‑term evidence on MHRA’s approval processes remains limited. This study analyses MHRA approval activity and timelines from 2021 to 2024, benchmarked against the US Food and Drug Administration (FDA), EMA, and Swissmedic.
METHODS: New active substance (NAS) approvals, including approval dates and regulatory pathways, were extracted from public FDA, EMA, Swissmedic, and MHRA databases. Regulatory output and reliance patterns were analysed descriptively for 2021-2024. In addition, a difference‑in‑differences (DiD) model (2016-2024) estimated changes in MHRA approval lags after Brexit, relative to the EMA.
RESULTS: Between 2021 and 2024, the MHRA approved 99 NASs, the fewest among peer regulators. The FDA approved the largest number (n=219), followed by EMA (n=127) and Swissmedic (n=124). Most MHRA approvals relied on prior decisions from EMA/European Commission (63%) or other international regulators (10%). Approval time lags in the NAS study cohort were shortest for the FDA (1.6 months), followed by EMA (5.3 months), MHRA (7.9 months), and Swissmedic (11.4 months). In the DiD analysis, MHRA approval times were 114% longer than EMA in the post-Brexit period (β = 0.76, p < 0.001).
CONCLUSIONS: This analysis suggests that Brexit‑related regulatory independence has not delivered faster or more autonomous approval processes: the MHRA approved the fewest NAS of the regulators studied and continues to rely on EMA decisions, although these reliance pathways have largely maintained UK access to new medicines. These findings highlight ongoing challenges for the MHRA in establishing a sustainable post‑Brexit model balancing sovereignty with efficiency, innovation, and timely patient access to medicines.
METHODS: New active substance (NAS) approvals, including approval dates and regulatory pathways, were extracted from public FDA, EMA, Swissmedic, and MHRA databases. Regulatory output and reliance patterns were analysed descriptively for 2021-2024. In addition, a difference‑in‑differences (DiD) model (2016-2024) estimated changes in MHRA approval lags after Brexit, relative to the EMA.
RESULTS: Between 2021 and 2024, the MHRA approved 99 NASs, the fewest among peer regulators. The FDA approved the largest number (n=219), followed by EMA (n=127) and Swissmedic (n=124). Most MHRA approvals relied on prior decisions from EMA/European Commission (63%) or other international regulators (10%). Approval time lags in the NAS study cohort were shortest for the FDA (1.6 months), followed by EMA (5.3 months), MHRA (7.9 months), and Swissmedic (11.4 months). In the DiD analysis, MHRA approval times were 114% longer than EMA in the post-Brexit period (β = 0.76, p < 0.001).
CONCLUSIONS: This analysis suggests that Brexit‑related regulatory independence has not delivered faster or more autonomous approval processes: the MHRA approved the fewest NAS of the regulators studied and continues to rely on EMA decisions, although these reliance pathways have largely maintained UK access to new medicines. These findings highlight ongoing challenges for the MHRA in establishing a sustainable post‑Brexit model balancing sovereignty with efficiency, innovation, and timely patient access to medicines.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR264
Topic
Health Policy & Regulatory
Topic Subcategory
Approval & Labeling
Disease
No Additional Disease & Conditions/Specialized Treatment Areas