United Kingdom Updates
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 ...
UK Profile Updated in ClinRegs
Mar 20, 2020 - The United Kingdom (UK) profile in ClinRegs has been reviewed and updated with the following:
Updated information on the UK’s withdrawal from the European Union and its impact on clinical research (See Scope of Assessment)
Updated information on electronic communication ...
United Kingdom: MHRA Issues Guidance for Clinical Trials Impacted by COVID-19
Mar 18, 2020 - On March 12, 2020, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued Advice for Management of Clinical Trials in relation to Coronavirus that provides information related to protocol deviation, sites, and participant safety.
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