UK Profile Updated in ClinRegs

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 provisions of the EU GDPR, unless indicated otherwise (See Definition of Sponsor, Quality and Data & Records Management, the Informed Consent topic, and Consent for Specimen)
• Medicines and Medical Devices Act 2021: gives greater regulatory authority to the Secretary of State for the Department of Health and Social Care (See the Regulation Authority topic)
• Guidance for Health and Social Care Researchers at the End of the Transition Period (updated) and Brexit: New Rules are Here webpage: both summarize post-transition changes in the life science and broader (See Scope of Assessment)
• Register to Make Submissions to the MHRA: provides updated guidance on regulatory submissions from January 1, 2021, including all clinical trial submissions (See Scope of Assessment and the Clinical Trial Lifecycle topic)
• MHRA User Reference Guide - Gaining Access to MHRA Submissions and the SOP - Submitting a CTA application to the MHRA: provide additional instruction on using and submitting information to the MHRA Submissions platform (See Scope of Assessment)
• Clinical Trials for Medicines: Apply for Authorization in the UK: updated to reflect post-transition requirements (See Scope of Assessment and the Clinical Trial Lifecycle topic)
• Procedures for UK Pediatric Investigation Plan (PIPs) and Completed Pediatric Studies - Submission, Processing, and Assessment: provides guidance on pediatric investigation plans and related reporting requirements (See Submission Content)
• IRAS - Templates for Supporting Documents webpage: updated to include new versions of model agreements (See Trial Initiation)
• Registration of Clinical Trials for Investigational Medicinal Products and Publication of Summary Results: provides guidance on registering a clinical trial (See Trial Initiation)
• Clinical Trials for Medicines: Manage Your Authorization, Report Safety Issues: updated to clarify requirements and obligations, and to facilitate reference safety information in multinational clinical trials (See Safety Reporting, Progress Reporting, and Quality and Data & Records Management)
• Guidance on Submitting Clinical Trial Safety Reports: provides guidance on reporting SUSARs using the new reporting routes, registering on the new national safety platforms (MHRA Gateway and eSUSAR), transitioning between reporting to EU and UK systems, and submitting DSURs to the MHRA (See Safety Reporting)
• UK Transition Guidance from the Human Tissues Authority: provides guidance on import of tissues and cells for human application from the EU, or to export tissues and cells intended for human application to the EU (See Specimen Import & Export)
• Combined Ways of Working program: updated to build on a pilot to provide a single application route and a coordinated ethics and regulatory review leading to a single UK decision on a clinical trial (See Submission Process subtopic)