We have summarized the major differences of clinical trial regulations in UK and EU.
Following Brexit, the European regulatory framework for clinical trials, namely the new EU Clinical Trials Regulation (EU) 536/2014 EUCTR, which took effect on 31.Jan.2022 no longer applies in Great Britain (i.e. England, Wales, and Scotland).
Note: Due to the Northern Ireland Protocol, parts of the EUCTR will apply in Northern Ireland.
Manufacturers looking into the conduct of clinical trials in the UK will be regulated by the Medicines and Healthcare products Regulatory Agency and the Research Ethics Service of Health Research Authority under the amended Medicines for Human Use (Clinical Trials) Regulations 2004.
Did you know?
The recent UK Medicines and Medical Devices Act 2021, a bill adopted on February 11, 2021, conferring power to amend or supplement the law relating to human medicines, veterinary medicines, and medical devices, provides powers to update the current legislation governing clinical trials.
Read more : Medicines and Medical Devices Act 2021
See here for an overview
