United Kingdom Updates
UK Profile Updated with Revised MHRA Fees
Apr 7, 2023 - The United Kingdom profile in ClinRegs has been updated to include the revised fee schedule for clinical trials, which was issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) on April 1, 2023 (See Regulatory Fees).
Sources Revised During this ...
UK Profile Updated
Jan 13, 2023 - The United Kingdom profile in ClinRegs has been reviewed for accuracy and updated with the following information:
Updates to the combined review processes for clinical trials (See Scope of Assessment and Clinical Trial Lifecycle topic)
Updated information about the UK Research Ethics ...
UK Profile Updated
Feb 24, 2022 - The United Kingdom profile in ClinRegs has been reviewed and updated with the following information:
Updates to responsibilities and contact information of the Medicines and Healthcare products Regulatory Agency (MHRA) (See Regulatory Authority)
Updated review and submission guidelines ...
UK: HRA Issues New Final Report Form
Sep 17, 2021 - On September 15, 2021, the Health Research Authority (HRA) implemented changes to final study reporting requirements, which will apply to all UK studies that require ethics approval and have not yet submitted a final report. The new final report form must be completed within 12 months of the ...
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 ...
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