UK · GCP Inspectorate
MHRA
Medicines & Healthcare products Regulatory Agency
12 documents in the Library — regulations, inspection procedures, guidance, Q&As, and reflection papers.
§ 01 — Documents
MHRA Clinical Trials for Medicines: Good Clinical Practice Inspections GUIDANCE 2026 HTML · — MHRA MHRA Clinical Trials for Medicines — GCP Guidance Collection NEW HUB 2026 HTML · — MHRA Guidance on Compliance with ICH E6 Good Clinical Practice (GCP) in the United Kingdom GUIDANCE 2025 HTML · — MHRA The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 NEW SI 2024/1234 REGULATION 2025 LINK · — MHRA CAPA Guidance for Formulating Responses to GCP Inspection Findings GUIDANCE 2025 PDF · 76 KB MHRA GCP Inspection Dossier Template TEMPLATE 2025 PDF · 153 KB MHRA Annual Review of Good Clinical Practice Referrals (Latest: 2022) ANNUAL REPORT 2022 PDF · 1.1 MB MHRA UK-Specific Annotations to ICH E6(R3) GUIDANCE 2025 HTML · 720 KB MHRA Notification of Serious Breaches of GCP or the Trial Protocol GUIDANCE 2025 HTML · — MHRA GCP Inspection Metrics — Annual Report (Latest: 2019-2020) ANNUAL REPORT 2020 PDF · 3.4 MB MHRA On-site Access to Electronic Health Records by Sponsor Representatives Under Review GUIDANCE 2024 HTML · — MHRA Oversight and Monitoring of Investigational Medicinal Product Trials Under Review GUIDANCE 2022 HTML · 480 KB