The UK’s Regulatory Landscape: A year and a half on from the end of the Brexit Transition Period.
by Iheoma Anosike
The United Kingdom’s (UK) post-Brexit transition period ended on 31 December 2020. The Medicines and Healthcare products Regulatory Agency (MHRA) became the UK’s independent regulatory Agency for medicines, medical devices and blood components for transfusion, with different requirements for products placed on the market in the UK with respect to Great Britain (England, Wales and Scotland) and Northern Ireland. The MHRA now makes decisions and carries out all functions which were performed at EU-level except for decisions on marketing authorisation applications (MAA) made through the European procedures to market products in Northern Ireland.
In the run up to 1 January 2021, the MHRA announced numerous new requirements and features associated with the UK’s emerging regulatory framework. Sponsors were encouraged to maintain a flexible approach towards their development programs in anticipation of further updates and guidance from the MHRA. This article summarises the latest guidance released by the MHRA, relating to medicines, since it became the UK’s standalone regulator.
Introduction
On 1 January 2021, EU pharmaceutical law ceased to be effective in Great Britain (GB), i.e., England, Wales and Scotland. Medicines and medical devices have since been regulated in GB under national law by the MHRA, with equivalent products in Northern Ireland falling under the jurisdiction of the EMA and EU legislation, in accordance with the Northern Ireland protocol, which came into effect on 1 January 2021. As the MHRA defines and develops its regulatory framework, updated guidance continues to be published by the Agency…