UK Profile Updated

May 16, 2024
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The United Kingdom profile in ClinRegs has been reviewed and updated with the following information: 

  • Updated Medicines and Healthcare Products Regulatory Agency (MHRA) guidance on a new notification scheme when applying for authorization to conduct a clinical trial (See Scope of Assessment and Submission Process)
  • MHRA guidance on common issues identified during the clinical trial application process (See Submission Process)
  • MHRA guidance on regulation and licensing for advanced therapy medicinal products (See Regulatory Authority, Manufacturing & Import, and Specimen Import & Export)
  • Updated regulatory fees payment requirements (See Regulatory Fees)
  • Health Research Authority (HRA) guidance outlining standard conditions for sponsors and investigators on the conduct and management of clinical trials (See Initiation, Agreements & Registration)
  • HRA Participant Information Quality Standards and Participant Information Design and Review Principles which includes guidance for the participant information sheet (See Documentation Requirements)
  • Principles, fact sheet, and other resources from 2023 and 2024 from the UK Department for Science, Innovation and Technology and the International Trade Association on the UK-US Data Bridge (See Personal Data Protection)
  • National Health Service resources for the DigiTrials program launched in 2023 that supports clinical trial researchers with secure data about potential participants (See Initiation, Agreements & Registration)

Sources Added During this Update:

(Guidance) Advanced Therapy Medicinal Products: Regulation and Licensing in Great Britain (G-ATMP) (Last Updated March 19, 2024)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Common Issues Identified During Clinical Trial Applications (CTapp-Issues) (Last Updated November 6, 2023)
Medicines and Healthcare Products Regulatory Agency

(Guidance) CTIMP Standard Conditions (CTIMP-Condtns) (Last Updated April 17, 2024)
Health Research Authority

(Guidance) Participant Information Design and Review Principles (PrtInfo-DesignPrin) (Last Updated August 21, 2023)
Health Research Authority

(Standards) Participant Information Quality Standards (PrtInfoQty-Stds) (Last Updated November 27, 2023)
Health Research Authority

(Document) Clinical Trials Best Practice Guide 2024 (GBR-10) (December 13, 2023)
Association for the British Pharmaceutical Industry, UK Research & Development (UKRD), and The Shelford Group

(Document) EudraCT & EU CTR Frequently Asked Questions (GBR-16) (January 31, 2024)
European Medicines Agency

(Document) Factsheet for UK Organisations on the UK-US Data Bridge (GBR-22) (2023)
Department for Science, Innovation and Technology

(Webpage) Clinical Trials in the European Union (GBR-39) (Current as of May 15, 2024)
European Commission, European Medicines Agency, and Heads of Medicines Agencies

(Webpage) Frequently Asked Questions: Quality Standards and Design and Review Principles (GBR-14) (Last Updated October 24, 2023)
Health Research Authority

(Webpage) NHS DigiTrials (GBR-40) (Current as of May 15, 2024)
National Health Service

(Webpage) People-Centered Clinical Research (GBR-34) (Last Updated November 2, 2023)
Health Research Authority

(Webpage) Services and Information: MHRA Services & Information for Patients and Healthcare Professionals (GBR-36) (March 29, 2023)
Medicines and Healthcare Products Regulatory Agency

(Webpage) UK-US Data Bridge: Data Privacy Framework Principles and List (GBR-19) (September 21, 2023)
Department for Science, Innovation and Technology

(Webpage) Welcome to the Data Privacy Framework (DPF) Program (GBR-23) (Current as of May 15, 2024)
International Trade Administration

Sources Revised During this Update:

(Guidance) Clinical Trials for Medicines: Apply for Authorisation in the UK (G-CTApp) (Last Updated April 10, 2024)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Manage Your Authorisation, Report Safety Issues (G-CTAuth-GBR) (Last Updated March 26, 2024)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Completed Pediatric Studies - Submission, Processing and Assessment (G-PIPs) (Last Updated February 1, 2023)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Good Manufacturing Practice and Good Distribution Practice (G-GMP-GDP) (Last Updated May 13, 2024)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Make a Payment to MHRA (G-MHRAPaymt) (Last Updated December 21, 2023)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Step-by-step Guide to Using IRAS for Combined Review (G-IRASCombRev) (Last Updated July 7, 2023) 
Health Research Authority

(Form) Clinical Trial of an Investigational Medicinal Product (CTIMP), Annual Progress Report to Research Ethics Committee (GBR-27) (Version 4.6) (Last Updated April 2024)
Health Research Authority

(Webpage) EudraCT – European Union Drug Regulating Authorities Clinical Trials Database (GBR-87) (Last Updated April 10, 2024)
European Medicines Agency

(Webpage) Good Clinical Practice for Clinical Trials (GBR-92) (Last Updated April 6, 2023) 
Medicines and Healthcare Products Regulatory Agency

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