United Kingdom Updates
UK: MHRA Announces Combined Regulatory and Ethics Review Starting in 2022
Jul 20, 2021 - On July 15, 2021, the United Kingdom’s (UK’s) Medicines and Healthcare products Regulatory Agency (MHRA) announced that starting in January 2022, all new Clinical Trials of Investigational Medicinal Products (CTIMPs) will undergo combined review from the MHRA and the UK Research Ethics ...
UK Profile Updated in ClinRegs
Jun 29, 2021 - The United Kingdom profile in ClinRegs now includes version 7.5 of the Standard Operating Procedures for Research Ethics Committees, issued by UK Health Departments’ Research Ethics Service in March 2021. No substantial edits were made to the topic areas
UK Profile Updated in ClinRegs
Apr 23, 2021 - The United Kingdom profile in ClinRegs has been reviewed and updated to reflect new and updated requirements following the Brexit transition period including:
UK General Data Protection Regulation (UK GDPR) (effective January 1, 2021): includes the same ...
UK: HRA Launches Fast-Track Ethics Review Pilot
Jan 7, 2021 - On January 4, 2021, the Health Research Authority (HRA) launched the fast-track research ethics review pilot, which will run until March 31, 2021. The pilot aims to test the demand for, and feasibility of a fast-track ethics review service that uses a dedicated ethics committee with expert ...
UK: Brexit Update and Related MHRA Guidance
Dec 30, 2020 - As of December 24, 2020, the UK and the European Union (EU) have reached a post-Brexit trade agreement. It is unlikely that the deal will be formally ratified before the transition period ends and Brexit comes into full force on January 1, 2021. See this website for more details about ...
UK Profile Updated in ClinRegs
Dec 8, 2020 - The United Kingdom profile in ClinRegs has been updated with the following information:
The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (No. 744), which allows new guidance documents to come into force post-Brexit on January 1, 2021 ...
United Kingdom: MHRA Issues Guidance for Clinical Trials Post-Brexit Transition Period
Sep 1, 2020 - On September 1, 2020, the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) issued the following guidance documents related to clinical trials after the Brexit transition period ends on December 31, 2020:
Registration of clinical trials for investigational ...
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