United Kingdom Profile Updated
United Kingdom Profile Updated
The United Kingdom profile in ClinRegs has been reviewed and updated with the following information:
- New clinical trial regulations that go into effect in April 2026 and related guidelines issued by Medicines and Healthcare Products Regulatory Agency (MHRA) and the Health Research Authority (HRA) (See Regulatory Authority)
- Legislation and guidance on personal data protection that clarify existing requirements, newly required transparency wording, and additional details on responsible parties for data protection (See Personal Data Protection)
- Updated HRA information on combined review with respect to review of clinical trial applications and clinical trial registration (See Scope of Assessment, Timeline of Review, and Initiation, Agreements & Registration)
- HRA retention guidance for relevant material (i.e., specimens) on premises not licensed by the Human Tissue Authority (See Specimen Import & Export)
- Updated HRA information on clinical trial approvals needed in England, Wales, Northern Ireland, and Scotland (See Scope of Assessment and Initiation, Agreements & Registration)
- Updated MHRA fees and payment instructions for clinical trials and development safety update reports (DSUR) (See Regulatory Fees)
- Updated model clinical trial agreements from HRA that apply UK-wide (See Initiation, Agreements & Registration)
- Updated information on the elimination of annual progress reporting requirements and content and online payment details for DSURs (See Safety Reporting and Progress Reporting)
- Revised standard operating procedures for research ethics committees (EC) related to annual and final reporting, EC recognition, study commencement, and Co-Chief Investigators (See Ethics Committee, Oversight of Ethics Committees, Initiation, Agreements & Registration, Progress Reporting, and Site/Investigator Selection)
- Updated MHRA contact information (See Regulatory Authority)
- Resources on developing people-centered research and involving the public (See Scope of Review and Risk & Quality Management)
- Additional details on MHRA’s authority to inspect clinical trials (See Scope of Assessment)
- Additional details on obtaining consent, testing the participant information sheet, and required elements of the informed consent form (See Documentation Requirements and Required Elements)
- Additional details on flagged ECs for research with prisoners (See Prisoners)
- Updated guidance and additional information on importing investigational products to the UK (See Manufacturing & Import)
- Additional information on the model material transfer agreement (See Specimen Import & Export)
- Information on UK membership in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and implementation of ICH guidelines (See Regulatory Authority)
- Updated guidance on procedures for pediatric investigation plans and completed pediatric studies (See Requirements)
- Updated guidance on biosimilars (See Additional Resources)
- Updated frequently asked questions on EudraCT and EU CTR (See Additional Resources)
- Updates to the Integrated Research Application System (IRAS) (See Additional Resources)
Sources Added During this Update:
(Legislation) Data (Use and Access) Act 2025 (DUAA) (Enacted June 19, 2025)
UK Parliament
(Regulation) The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 (MHCTR2024) (Effective April 10, 2026)
UK Parliament
(Guidance) Guidance on Changes to the Clinical Trials Regulations (MHCTR-Chgs) (Current as of July 10, 2025)
Health Research Authority
(Guidance) More Information about the MHRA (MHRA-More) (January 16, 2023)
Medicines and Healthcare Products Regulatory Agency
(Guidance) The Data Use and Access Act 2025 (DUAA) - Summary of the Changes to Data Protection Law (DUAA-Sum) (June 19, 2025)
Information Commissioner’s Office
(Guidance) The Data Use and Access Act 2025 (DUAA) - What Does It Mean for Organisations? (DUAA-Org) (June 19, 2025)
Information Commissioner’s Office
(Form) Model Material Transfer Agreement (GBR-79) (September 2021)
Health Research Authority
(International Guidance) ICH Harmonised Tripartite Guideline: Development Safety Update Report (E2F) (GBR-61) (Step 4 Version) (August 17, 2010)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(Webpage) GDPR Transparency Wording for all Sponsors (GBR-53) (Last Updated April 4, 2025)
Health Research Authority
(Webpage) ICH Guideline Implementation (GBR-45) (Current as of July 10, 2025)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(Webpage) ICH Members & Observers (GBR-44) (Current as of July 10, 2025)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(Webpage) International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines (GBR-80) (Last Updated December 19, 2024)
Medicines and Healthcare Products Regulatory Agency
(Webpage) New UK Clinical Trials Regulations Signed into Law – Implementation Period Begins (GBR-74) (Last Updated April 11, 2025)
Health Research Authority
(Webpage) Pay for a DSUR Submission (GBR-43) (Current as of July 10, 2025)
Medicines and Healthcare Products Regulatory Agency
(Webpage) People-Centred Clinical Research (GBR-71) (Last Updated August 8, 2024)
Health Research Authority
(Webpage) Public Involvement (GBR-46) (Current as of July 10, 2025)
Health Research Authority
Sources Revised During this Update:
(Regulation) The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031) (MHCTR) (Current through July 10, 2025)
Department of Health and Social Care
(Guidance) Advanced Therapy Medicinal Products: Regulation and Licensing in Great Britain (G-ATMP) (Last Updated March 6, 2025)
Medicines and Healthcare Products Regulatory Agency
(Guidance) Authorizations and Procedures Required for Importing Investigational Medicinal Products to Great Britain from Approved Countries (G-ImportIMPsAuth) (Last Updated February 12, 2025)
Medicines and Healthcare Products Regulatory Agency
(Guidance) Clinical Trials for Medicines: Manage Your Authorisation, Report Safety Issues (G-CTAuth-GBR) (Last Updated June 9, 2025)
Medicines and Healthcare Products Regulatory Agency
(Guidance) Completed Pediatric Studies - Submission, Processing, and Assessment (G-PIPs) (Last Updated February 13, 2025)
Medicines and Healthcare Products Regulatory Agency
(Guidance) Consent and Participant Information Guidance (G-ConsentPIS) (Version 12) (June 2024)
Medical Research Council, Health Research Authority
(Guidance) CTIMP Standard Conditions (CTIMP-Condtns) (Last Updated July 29, 2024)
Health Research Authority
(Guidance) GDPR Guidance for Researchers and Study Coordinators (G-GDPR) (Current as of July 10, 2025)
Health Research Authority
(Guidance) Guidance on the Licensing of Biosimilar Products (G-Biosimilars) (Last Updated February 27, 2025)
Medicines and Healthcare Products Regulatory Agency
(Guidance) Importing Investigational Medicinal Products into Great Britain from Approved Countries (G-ImportIMPs) (Last Updated February 12, 2025)
Medicines and Healthcare Products Regulatory Agency
(Guidance) List of Approved Countries for Clinical Trials and Investigational Medicinal Products (G-CTApprovedCountries) (Last Updated February 12, 2025)
Medicines and Healthcare Products Regulatory Agency
(Guidance) Make a Payment to MHRA (G-MHRAPaymt) (Last Updated December 19, 2024)
Medicines and Healthcare Products Regulatory Agency
(Guidance) Procedures for UK Paediatric Investigation Plan (PIPs) (G-PIPsProcess) (Last Updated December 31, 2024)
Medicines and Healthcare Products Regulatory Agency
(Guidance) Statutory Guidance: Current MHRA Fees (G-MHRAFees) (Effective April 1, 2025)
Medicines and Healthcare Products Regulatory Agency
(Guidance) Step-by-step Guide to Using IRAS for Combined Review (G-IRASCombRev) (Last Updated September 16, 2024)
Health Research Authority
(Document) EudraCT & EU CTR Frequently Asked Questions (GBR-16) (Version 2.5) (January 31, 2025)
European Medicines Agency
(Webpage) EudraCT – European Union Drug Regulating Authorities Clinical Trials Database (GBR-87) (Last Updated June 26, 2025)
European Medicines Agency
(Webpage) HRA Approval (GBR-67) (Last Updated February 14, 2025)
Health Research Authority
(Webpage) IRAS - Templates for Supporting Documents (GBR-107) (Last Updated June 20, 2025)
Health Research Authority, Department of Health and Social Care
(Webpage) Integrated Research Application System (IRAS) (GBR-78) (Version 6.4) (Last Updated February 4, 2025)
Health Research Authority
(Webpage) Progress Reports (GBR-65) (Last Updated February 26, 2025)
Health Research Authority
(Webpage) Safety Reporting (GBR-99) (Last Updated August 9, 2024)
Health Research Authority