United Kingdom Profile Updated

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

• Implementation of the amended United Kingdom (UK) clinical trials regulations, effective April 28, 2026, including updated terminology and transitional arrangements for existing and new clinical trials (reflected throughout the profile)
• Updated clinical trial approval and combined review requirements, including validation, review timelines, requests for further information, appeals, approval lapse provisions, consultations, and the notifiable trial pathway (See Scope of Assessment, Scope of Review, Submission Process, and Timeline of Review)
• New clinical trial modification framework, including minor modifications, modifications of an important detail, and Route A and Route B substantial modifications (See Scope of Assessment, Regulatory Fees, and Site/Investigator Selection)
• Updated research ethics review and informed consent requirements, including ethics committee governance and simplified consent arrangements for eligible low-intervention clinical trials (See the Ethics Committee topic and Documentation Requirements)
• Implementation of ICH E6(R3) Good Clinical Practice and E8(R1), including UK-specific annotations and updated risk-proportionate approaches to trial conduct and oversight, and alignment with the principles of the Declaration of Helsinki (See Regulatory Authority, Initiation, Agreements & Registration, and Risk & Quality Management)
• Updated research transparency and safety reporting requirements, including trial registration, results reporting, SUSARs, urgent safety measures, and Development Safety Update Reports (See Initiation, Agreements & Registration, Safety Reporting, and Progress Reporting)
• Updated UK-wide study governance and site-level R&D review requirements, including centralized study-wide assessment of governance and legal compliance across the UK nations and parallel local review of participating organizations’ capacity and capability to deliver the research (See Initiation, Agreements & Registration)
• Updated sponsor, investigator, and trial site responsibilities, including investigator eligibility and training, insurance and compensation, trial oversight and serious breach notification, responsibilities for computerized systems and laboratories, and recordkeeping and archiving requirements (See the Sponsorship topic)
• Updated investigational medicinal product requirements, including manufacture, import, labeling, supply, point-of-care and modular manufacture, and transitional provisions under the amended regulations (See the Investigational Products topic)
• Updated data protection requirements and guidance, including implementation of relevant provisions of the Data (Use and Access) Act 2025 (See Personal Data Protection)
• Additional pharmacovigilance contacts and nation-specific regulatory and research support contacts across the UK (See Regulatory Authority)
• Additional and updated legislation, guidance, forms, tools, and other regulatory resources added throughout the profile

Sources Added During this Update:

(Guidance) Applying a Proportionate Approach to Seeking and Evidencing Informed Consent in Health and Social Care Research (Cnst-Proprt) (Last Updated April 24, 2026)
Health Research Authority

(Guidance) Clinical Trials for Medicines: Apply for Approval in the UK (CTApp-Appvl) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Archiving and Retention of Clinical Trial Records (CTRecords) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Clinical Trials Regulations Transitional Arrangements (CT-Transtn) (Last Updated July 15, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Collection, Verification and Reporting of Safety Events (CT-Sfty) (Last Updated July 15, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Compliance with ICH E6 Good Clinical Practice (GCP) in the United Kingdom (UK-ICHE6-Comply) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Diagnostic Radiopharmaceutical Investigation Medicinal Products and Good Manufacturing Practice Requirements (GMP-RadioPharm) (April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Ending a Clinical Trial (EndingCT) (Last Updated July 15, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Expert Advice (CT-Experts) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Good Clinical Practice Inspections (GCP-Inspct) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Good Manufacturing Practice and Radiopharmaceutical Investigational Medicinal Products (CT-GMP) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Guidance on Quality and Risk Proportionality (Qlty-Risk) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: International Council for Harmonisation (ICH) Annotations (UKannot-ICH) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Labelling (IPLabeling) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Modifying a Clinical Trial Approval (CTMod) (Last Updated August 19, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Notifiable Trials (CT-Ntfble) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Notification of Serious Breaches of GCP or the Trial Protocol (SrsBreachNotif) (April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Roles and Responsibilities (CT-Roles) (Last Updated July 7, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Declaration of Helsinki and Clinical Trial Regulations Alignment (Hlsnki-Align) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Document Management for Combined Review Applications (DocMgt-Apps) (Last Updated July 2, 2026)
Health Research Authority

(Guidance) Formulating Responses to GCP Inspection Findings (Inspct-Resp) (Version 3) (February 20, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Medicines: Clinical Trials Hub (CT-Hub) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Medicines: Get Scientific Advice from the MHRA (MHRA-advice) (Last Updated August 14, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Payments and Incentives in Research (Compstn) (Last Updated May 18, 2026)
Health Research Authority, UK Research Ethics Development Group

(Guidance) Phase 1 Clinical Trials (Phs1CTs) (Last Updated April 28, 2026)
Health Research Authority

(Guidance) Public Health Emergency Research (PubHlth-Emrgcy) (Last Updated June 4, 2026)
Health Research Authority

(Guidance) Research in Emergency Settings (Rsrch-Emrgcy) (Last Updated September 10, 2024)
Health Research Authority

(Guidance) UK-specific Annotations to ICH E6(R3) (UKannot-E6R3) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) UK-specific Annotations to ICH E8 (UKannot-E8) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) UK Study-wide Governance Criteria (Stdy-wide) (Version 6.2) (April 24, 2026)
Health Research Authority

(Legislation) Commission Directive 2003/94/EC of 8 October 2003 Laying Down the Principles and Guidelines of Good Manufacturing Practice in Respect of Medicinal Products for Human Use and Investigational Medicinal Products for Human Use (EC Directive 2003/94/EC) (GBR-GMP-EU) (October 8, 2003)
European Commission

(Regulation) Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 Supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying The Principles of and Guidelines for Good Manufacturing Practice for Investigational Medicinal Products for Human Use and Arrangements for Inspections (2017/1569) (NI-GMP-EU) (December 31, 2020)
European Commission

(Regulation) The Data (Use and Access) Act 2025 (Commencement No. 6 and Transitional and Saving Provisions) Regulations 2026 (S.I. 2026/82) (DUAA-Cmmct) (January 29, 2026)
UK Parliament

(Article) Clinical Trials Regulations: Modification Tool Launched (GBR-83) (Last Updated April 28, 2026)
Health Research Authority

(Document) User Reference Guide – Paying Online before Submitting a Development Safety Update Report (DSUR) (GBR-96) (Date Unavailable)
Medicines and Healthcare Products Regulatory Agency

(Flowchart) Figure 1. Decision Tree for Determining the Correct Category for a Modification (Version 1.3) (GBR-84) (June 8, 2026)
Medicines and Healthcare Products Regulatory Agency

(Flowchart) Figure 1. Flowchart Summarising the Process of Applying for Clinical Trial Approval (Version 1.2) (GBR-82) (January 5, 2026)
Medicines and Healthcare Products Regulatory Agency

(Flowchart) Figure 2. Flowchart Summarising the Process of Applying for Approval of a Route A Substantial Modification (Version 1.2) (GBR-88) (January 5, 2026)
Medicines and Healthcare Products Regulatory Agency

(Form) Confirmation of Notifiable Trial Criteria (GBR-135) (Version 1.0) (April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Form) Notification of a Substantial Modification to a Clinical Trial of a Medicinal Product for Human Use to the MHRA (GBR-134) (Date Unavailable)
Medicines and Healthcare Products Regulatory Agency

(Form) Notification of Serious Breach of GCP or Trial Protocol (GBR-108) (Version 8.0) (April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(International Guidance) Community Code Relating to Medicinal Products for Human Use (Directive 2001/83/EC) (GBR-109) (Effective February 28, 2002)
European Parliament and Council of the European Union

(International Guidance) Declaration of Helsinki (GBR-81) (October 2024)
World Medical Association

(International Guidance) E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files (GBR-94) (Last Updated January 2026)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(International Guidance) General Considerations for Clinical Studies E8(R1) (GBR-104) (Implemented April 28, 2026)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(International Guidance) ICH Harmonised Guideline: Guideline for Good Clinical Practice E6(R3) (GBR-91) (Implemented April 28, 2026)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(Press Release) Launch of Clinical Trial Reforms (GBR-90) (April 27, 2026)
Medicines and Healthcare Products Regulatory Agency, Health Research Authority, and Dr Zubir Ahmed, Parliamentary Under-Secretary of State for Health Innovation and Safety

(Table) Table 1: Route B Substantial Modifications in Modifying a Clinical Trial Approval (Version 1.1) (GBR-85) (April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Webpage) Data (Use and Access) Act 2025 (GBR-136) (Current as of August 26, 2026)
Information Commissioner’s Office

(Webpage) HRA Assessment Review Portal (HARP) (GBR-139) (Last Updated May 7, 2026)
Health Research Authority

(Webpage) International Clinical Trials Registry Platform (ICTRP) (GBR-93) (Current as of August 26, 2026)
World Health Organization

(Webpage) International Transfers (GBR-138) (Current as of August 26, 2026)
Information Commissioner’s Office

(Webpage) Medicines and Healthcare Products Regulatory Agency Homepage (GBR-71) (Current as of August 26, 2026)
Medicines and Healthcare Products Regulatory Agency

Sources Revised During this Update:

(Guidance) Code A: Guiding Principles and the Fundamental Principle of Consent (Code-A) (June 30, 2023)
Human Tissue Authority

(Guidance) Code E: Research - Code of Practice and Standards (Code-E) (June 30, 2023)
Human Tissue Authority

(Guidance) Common Issues Identified During Clinical Trial Applications (CTapp-Issues) (Last Updated April 28, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Consent and Participant Information Guidance (G-ConsentPIS) (Version 14) (April 2026)
Medical Research Council, Health Research Authority

(Guidance) CTIMP Standard Conditions (CTIMP-Condtns) (Last Updated April 28, 2026)
Health Research Authority

(Guidance) Guidance on Changes to the Clinical Trials Regulations (MHCTR-Chgs) (Current as of August 26, 2026)
Health Research Authority

(Guidance) International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines (ICH-UKimp) (Last Updated May 19, 2026)
Medicines and Healthcare Products Regulatory Agency

(Guidance) IRAS User Guide (IRAS-User) (Current as of August 26, 2026)
Health Research Authority

(Guidance) Step-by-step Guide to Using IRAS for Combined Review (G-IRASCombRev) (Last Updated April 28, 2026)
Health Research Authority

(Guidance) UK Research Ethics Committee (REC) Policy Document (REC-Policy) (Version 1.0) (April 28, 2026)

UK Health Departments

(Regulation) UK General Data Protection Regulation (UK-GDPR) (Current through August 21, 2026)
UK Parliament

(Toolkit) Carrying Out Research Across Borders (UKwide-Rsrch) (Current as of August 26, 2026)
National Health Service (NHS) Research Scotland

(Document) Standard Operating Procedures for Research Ethics Committees (GBR-9) (Version 8.1) (Effective June 16, 2026)
UK Health Departments Research Ethics Service, Health Research Authority, Health and Social Care Northern Ireland, NHS Research Scotland

(Webpage) Applying to a Research Ethics Committee (GBR-68) (Last Updated April 28, 2026)
Health Research Authority

(Webpage) Clinical Trials Toolkit – Routemap (GBR-18) (Current as of August 26, 2026)
National Institute for Health and Care Research

(Webpage) Combined Review (GBR-72) (Last Updated April 28, 2026)
Health Research Authority

(Webpage) Contact the MHRA (GBR-58) (Last Updated June 11, 2026)
Medicines and Healthcare Products Regulatory Agency

(Webpage) Ending Your Project (GBR-128) (Last Updated April 28, 2026)
Health Research Authority

(Webpage) Examples of Modification Types (GBR-98) (Last Updated May 18, 2026)
Health Research Authority

(Webpage) HRA Approval (GBR-67) (Last Updated April 28, 2026)
Health Research Authority

(Webpage) Integrated Research Application System (IRAS) (GBR-78) (Version 6.4) (Last Updated April 28, 2026)
Health Research Authority

(Webpage) IRAS - Templates for Supporting Documents (GBR-107) (Last Updated April 28, 2026)
Health Research Authority, Department of Health and Social Care

(Webpage) Medicines: Application Forms for a Manufacturer License (GBR-28) (Last Updated July 14, 2025)
Medicines and Healthcare Products Regulatory Agency

(Webpage) Research with Potentially Vulnerable People (GBR-131) (Last Updated July 27, 2026)
UK Research and Innovation

(Webpage) Roles and Responsibilities (GBR-103) (Last Updated April 28, 2026)
Health Research Authority

(Webpage) Safety Reporting (GBR-99) (Last Updated April 28, 2026)
Health Research Authority

(Webpage) UK Policy Framework for Health and Social Care Research (GBR-101) (Version 3.4) (Last Updated April 28, 2026)
Health Research Authority (England), the Department of Health and Social Care (Northern Ireland), the Scottish Government Health and Social Care Directorates, and the Department for Health and Social Services (Wales)

(Webpage) Use of Human Tissue in Research (GBR-73) (Last Updated September 1, 2025)
Health Research Authority