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Abstract

Brexit has transformed the United Kingdom’s pharmaceutical and medical device regulatory framework, shifting authority from the European Medicines Agency (EMA) to the Medicines and Healthcare products Regulatory Agency (MHRA). With full independence, MHRA introduced new pathways to accelerate patient access to medicines, including the Innovative Licensing and Access Pathway (ILAP), Rolling Review, and a 150-day national assessment route. Centrally authorized products now require conversion to Great Britain Marketing Authorizations, while medical devices transitioned from the CE mark to the UKCA mark. These changes, alongside collaborations with International Council for Harmonisation (ICH) countries, aim to ensure timely availability of safe and effective products. Early outcomes suggest the UK is positioning itself as a leader in pharmaceutical innovation and regulation, with faster approvals and streamlined processes. However, given the short timeframe since Brexit, the full impact of MHRA’s independent role remains to be seen, with long-term effects likely to emerge in the coming years.

Fields of Study & Subjects

Healthcare Regulation Biomedical Ethics and Regulation Pharmaceutical Economics and Policy

Publication details

Journal / source
Zenodo (CERN European Organization for Nuclear Research)
Publication date
11 March 2026
Language
EN