UK Profile Updated

February 24, 2022
Subscribe to these updates

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 for the new combined review process for new clinical trial applications, which offers a single application route and coordinated review from the MHRA and the ethics committee leading to a single UK decision (See Scope of Assessment, Scope of Review, Submission Process, Timeline of Review, Trial Authorization)
  • New fast-track ethics review procedures via combined review for certain global clinical trials and Phase I trials (See Scope of Review)
  • New clinical trial registration procedures as a result of UK’s “Make it Public” research transparency strategy (See Trial Initiation)
  • Updated requirements and guidance for safety and final reports, including a joint MHRA-Canada policy about improving the quality of Development Safety Update Reports (See Safety Reporting, Progress Reporting)
  • Clarifications regarding storage of human tissue and EC approval (See Specimen Import & Export).

Note: The UK’s transition to Combined Review and other post-Brexit procedures are evolving and ClinRegs will monitor and update the profile, as needed.

Sources Added During this Update:

(Guidance) Authorizations and Procedures Required for Importing Investigational Medicinal Products to Great Britain from Approved Countries (G-ImportIMPsAuth) (Last Updated December 22, 2021)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Guidance on the Licensing of Biosimilar Products (G-Biosimilars) (May 6, 2021)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Guideline on How to Increase Transparency when Presenting Safety Information in the Development Safety Update Report (DSUR): Region-specific Requirements for Canada and the United Kingdom (DSUR-UK_Canada) (July 6, 2021)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Oversight and Monitoring of Investigational Medical Product Trials (G-Ovrsight) (January 28, 2022)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Risk-Adapted Approach to Clinical Trials and Risk Assessments (G-RiskAssmt) (January 28, 2022)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Step-by-step Guide to Using IRAS for Combined Review (G-IRASCombRev) (Last Updated February 1, 2022)
Health Research Authority

(Guidance) Supplying Investigational Medicinal Products to Northern Ireland (G-IPsNIreland) (Last Updated December 22, 2021)
Medicines and Healthcare Products Regulatory Agency

(Document) Research and the Human Tissue Act 2004 - Consent (GBR-59) (Version 3) (January 2019)
Medical Research Council

(Form) Submit your Final Report - Health Research Authority (GBR-20) (Current as of February 23, 2022)
Health Research Authority

(Webpage) Clinical Trials in the European Union (GBR-121) (Current as of February 23, 2022)
European Union

(Webpage) IRAS Development Questions and Answers (GBR-122) (Last Updated February 15, 2022)
Health Research Authority

(Webpage) Research Transparency (GBR-55) (Last Updated October 11, 2021)
Health Research Authority

(Webpage) Staying Connected with Your Participants (GBR-117) (Current as of February 23, 2022)
Parkinson’s UK

(Webpage) The Northern Ireland Protocol - Details of the agreement reached by Withdrawal Agreement Joint Committee regarding the implementation of the Northern Ireland Protocol (GBR-119) (Last Updated January 5, 2021)
United Kingdom Cabinet Office

(Webpage) UK Transition Licensing FAQs (GBR-56) (Last Updated September 13, 2021)
Human Tissue Authority

(Webpage) Writing a Plain Language (Lay) Summary of Your Research Findings (GBR-120) (Last Updated November 9, 2021)
Health Research Authority

(Not Available Online) NIAID Communication with Health Research Authority (December 2021) (GBR-118)
Health Research Authority

Sources Revised During this Update:

(Guidance) Clinical Trials for Medicines: Apply for Authorisation in the UK (G-CTApp) (Last Updated January 7, 2022)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Clinical Trials for Medicines: Manage Your Authorisation, Report Safety Issues (G-CTAuth) (Last Updated February 7, 2022)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Consent and Participant Information Guidance (G-ConsentPIS) (Version 11) (March 2021)
Medical Research Council, Health Research Authority

(Guidance) Governance Arrangements for Research Ethics Committees: 2020 Edition (GAfREC) (Version 2.1) (Last Updated July 20, 2021)
UK Health Departments

(Guidance) Guidance for Health and Social Care Researchers at the End of the Transition Period (G-AfterTransition) (Last Updated December 30, 2021)
Health Research Authority

(Guidance) Importing Investigational Medicinal Products into Great Britain from Approved Countries (G-ImportIMPs) (Last Updated December 22, 2021)
Medicines and Healthcare Products Regulatory Agency

(Guidance) List of Approved Countries for Clinical Trials and Investigational Medicinal Products (G-CTApprovedCountries) (Last Updated December 22, 2021)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Make a Payment to MHRA (G-MHRAPaymt) (Last Updated September 15, 2021)
Medicines and Healthcare Products Regulatory Agency

(Guidance) On-Site Access to Electronic Health Records by Sponsor Representatives in Clinical Trials (G-EHRAccess) (September 8, 2021)
Medicines and Healthcare Products Regulatory Agency

(Guidance) Quality and Safety of Human Blood and Blood Products (G-QualityBlood) (Last Updated May 27, 2021)
Department of Health and Social Care

(Guidance) UK Transition Guidance (G-Tissues-Brexit) (Last Updated September 13, 2021)
Human Tissue Authority

(International Agreement) Agreement on the Withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (WithdrlAgrmt) (December 18, 2020)
European Union, European Atomic Energy Community, and the United Kingdom of Great Britain and Northern Ireland

(Document) Governance Review Check Guidelines (GBR-29) (Version 5.0) (November 21, 2021)
Health Research Authority

(Document) RES SOPs (Version 7.5.1) Summary of Changes (GBR-8) (August 2021)
UK Health Departments’ Research Ethics Service, Health Research Authority

(Document) SOP – Submitting a CTA Application to the MHRA (GBR-17) (Version 13.0) (Effective November 2, 2021)
Imperial College London, National Health Service

(Document) Sponsorship Principles (Research and Development Forum) (GBR-2) (Version 1.0) (February 2021)
Research and Development Forum, National Health Service

(Document) Standard Operating Procedures for Research Ethics Committees (GBR-9) (Version 7.5.1) (August 2021)
UK Health Departments’ Research Ethics Service, Health Research Authority

(Webpage) Applying to a Research Ethics Committee (GBR-68) (Last Updated August 2, 2021)
Health Research Authority

(Webpage) Brexit (GBR-60) (Current as of February 23, 2022)
Government of United Kingdom

(Webpage) Clinical Trials Regulation (GBR-54) (Current as of February 23, 2022)
European Medicines Agency

(Webpage) Combined Review (GBR-72) (Last Updated February 17, 2022)
Health Research Authority

(Webpage) Contact MHRA (GBR-58) (Last Updated February 14, 2022)
Medicines and Healthcare Products Regulatory Agency

(Webpage) eSUSAR (GBR-50) (Current as of February 23, 2022)
Medicines and Healthcare Products Regulatory Agency

(Webpage) EudraCT – European Union Drug Regulating Authorities Clinical Trials Database (GBR-87) (Version 10.5.0.0) (Last Updated December 15, 2021)
European Medicines Agency

(Webpage) Fast-track Research Ethics Review (GBR-116) (Last Updated February 22, 2022)
Health Research Authority

(Webpage) Four Nations Policy Leads Group (GBR-97) (Last Updated September 20, 2021)
Health Research Authority

(Webpage) Good Clinical Practice for Clinical Trials (GBR-92) (Last Updated January 28, 2022)
Medicines and Healthcare Products Regulatory Agency

(Webpage) HRA Approval (GBR-67) (Last Updated November 22, 2021)
Health Research Authority

(Webpage) Integrated Research Application System (IRAS) Login Page (GBR-78) (Version 6.1) (Last Updated January 4, 2022)
Health Research Authority

(Webpage) IRAS - Templates for Supporting Documents (GBR-107) (Last Updated February 10, 2022)
Health Research Authority, Department of Health and Social Care

(Webpage) Online Booking Service (GBR-95) (Last Updated December 24, 2021)
Health Research Authority

(Webpage) Progress Reports (GBR-65) (Last Updated June 7, 2021)
Health Research Authority

(Webpage) Research Ethics Service (GBR-62) (Last Updated November 8, 2021)
Health Research Authority

(Webpage) Research Registration and Research Project Identifiers (GBR-102) (Last Updated January 31, 2022)
Health Research Authority, Department of Health and Social Care

(Webpage) Roles and Responsibilities (GBR-103) (Last Updated May 26, 2021)
Health Research Authority

(Webpage) Safety Reporting (GBR-99) (Last Updated September 6, 2021)
Health Research Authority

(Webpage) UK Policy Framework for Health and Social Care Research (GBR-101) (Last Updated October 30, 2020)
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 November 16, 2021)
Health Research Authority

Back to list