§ 03 — THE LIBRARY
· BROWSE
The full catalog.
Showing 77 of 77 documents across 7 authorities. Search by title, citation, or abstract; filter by authority, type, year, status, or format.
§ 01 — Filter
MHRA Clinical Trials for Medicines: Good Clinical Practice Inspections GUIDANCE 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 NMPA NMPA Announcement on Adoption of ICH E6(R3) Good Clinical Practice Guideline NEW NMPA Announcement No. 125 of 2025 NOTICE 2025 HTML · — FDA Processes and Practices Applicable to Bioresearch Monitoring Inspections NEW GUIDANCE 2025 PDF · — EMA Annual Report of the Good Clinical Practice Inspectors Working Group 2024 NEW EMA/INS/GCP/37608/2025 ANNUAL REPORT 2024 PDF · — ICH E6(R3) Annex 2 — Non-Traditional Interventional Clinical Trials NEW Draft E6(R3) Annex 2 GUIDELINE 2025 PDF · — NMPA Guiding Principles for Computerized Systems and Electronic Data in Drug Clinical Trials (Draft for Comment) NEW Draft CDE, November 2025 GUIDANCE 2025 PDF · — MHRA Annual Review of Good Clinical Practice Referrals (Latest: 2022) ANNUAL REPORT 2022 PDF · 1.1 MB NMPA Good Clinical Practice for Drugs (2025 Revision — Draft for Comments) NEW Draft REGULATION 2025 DOCX · — EMA Recommendation Paper on Decentralised Elements in Clinical Trials GUIDANCE 2025 PDF · — FDA E6(R3) Good Clinical Practice — Final Guidance for Industry GUIDANCE 2025 PDF · 2.1 MB MHRA UK-Specific Annotations to ICH E6(R3) GUIDANCE 2025 HTML · 720 KB EMA ICH E6(R3) Good Clinical Practice — CHMP Adoption CHMP/ICH/135/1995 GUIDELINE 2025 PDF · 3.1 MB MHRA Notification of Serious Breaches of GCP or the Trial Protocol GUIDANCE 2025 HTML · — ICH E20 Adaptive Designs for Clinical Trials NEW Draft E20 GUIDELINE 2025 PDF · — FDA Bioresearch Monitoring Program — Clinical Investigators and Sponsor-Investigators CP 7348.811 COMPLIANCE PROGRAM 2025 PDF · — FDA Bioresearch Monitoring Program — Institutional Review Boards NEW CP 7348.809 COMPLIANCE PROGRAM 2025 PDF · 293 KB EMA Reflection Paper on Risk-Based Quality Management in Clinical Trials REFLECTION PAPER 2025 PDF · 1.2 MB NMPA Inspection Checkpoints and Judging Principles for Drug Clinical Trials NEW INSPECTION PROCEDURE 2025 PDF · — ICH E6(R3) Good Clinical Practice — Step 4 Final Guideline E6(R3) GUIDELINE 2025 PDF · 3.1 MB MHRA GCP Inspection Metrics — Annual Report (Latest: 2019-2020) ANNUAL REPORT 2020 PDF · 3.4 MB EMA Mutual Reliance Initiative for GCP Inspections (EU–FDA) NOTICE 2024 HTML · — FDA Decentralized Clinical Trials for Drugs, Biological Products, and Devices GUIDANCE 2024 PDF · 650 KB EMA Reflection Paper on Use of Artificial Intelligence in the Medicinal Product Lifecycle REFLECTION PAPER 2024 PDF · 1.1 MB FDA Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations Draft GUIDANCE 2024 PDF · 880 KB NMPA Technical Guidelines for Evaluation of the Relevance of Adverse Events in Drug Clinical Trials NEW No. 31 of 2024 GUIDANCE 2024 PDF · ~500 KB NMPA CDE Guidance on Centralised Monitoring GUIDANCE 2024 LINK · — MHRA On-site Access to Electronic Health Records by Sponsor Representatives Under Review GUIDANCE 2024 HTML · — FDA Electronic Records; Electronic Signatures 21 CFR Part 11 REGULATION 2024 LINK · — FDA Financial Disclosure by Clinical Investigators NEW 21 CFR Part 54 REGULATION 2024 LINK · — HC Food and Drug Regulations — Division 5 (Clinical Trials) C.05 REGULATION 2024 LINK · — EMA Guidance on Remote GCP Inspections During Public Health Threats, Political Conflicts, Natural Disasters, or Other Major Disruptions NEW EMA/INS/GCP/397876/2023 GUIDANCE 2024 PDF · 292 KB FDA Institutional Review Boards 21 CFR Part 56 REGULATION 2024 LINK · — FDA Investigational New Drug Application 21 CFR Part 312 REGULATION 2024 LINK · — FDA Protection of Human Subjects 21 CFR Part 50 REGULATION 2024 LINK · — EMA Q&A on Good Clinical Practice (GCP) NEW Q&A 2024 HTML · — EMA Annex III — Computer Systems NEW EMA/INS/GCP/155774/2022 INSPECTION PROCEDURE 2023 PDF · 180 KB EMA Reflection Paper on the Use of Interactive Response Technologies in Clinical Trials NEW EMA/151704/2023 REFLECTION PAPER 2023 PDF · — FDA Bioresearch Monitoring Program — Sponsors, Contract Research Organizations, and Monitors CP 7348.810 COMPLIANCE PROGRAM 2023 PDF · 1.4 MB PMDA Checklist for GCP On-site Inspection / Document-based Compliance Assessment for New Drug (for Sponsor) NEW TEMPLATE 2023 DOCX · 89 KB PMDA Checklist for GCP On-site Inspection for New Drug (for Medical Institution) NEW TEMPLATE 2023 DOCX · 105 KB PMDA GCP Inspection Submission Forms — Official Download Portal NEW TEMPLATE 2023 HTML · — PMDA Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products NEW PMDA/CPE Notification No. 325 INSPECTION PROCEDURE 2023 PDF · 197 KB EMA Guideline on Computerised Systems and Electronic Data in Clinical Trials EMA/INS/GCP/112288/2023 GUIDANCE 2023 PDF · 1.8 MB FDA A Risk-Based Approach to Monitoring of Clinical Investigations — Questions and Answers NEW Q&A 2023 PDF · — HC Good Clinical Practices — Inspection Guidance GUI-0100 GUIDANCE 2023 PDF · 2.7 MB FDA Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations — Questions and Answers NEW Draft Q&A 2023 PDF · — PMDA Compliance Inspection under PMD Act — Overview NEW GUIDANCE 2023 PDF · — ICH E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials NEW E19 GUIDELINE 2022 PDF · — EMA Annex I — Investigator Site NEW EMA/INS/GCP/143492/2022 INSPECTION PROCEDURE 2022 PDF · 232 KB EMA Annex IV — Sponsor and Contract Research Organisations (CRO) EMA/INS/GCP/155794/2022 INSPECTION PROCEDURE 2022 PDF · 293 KB EMA Annex VI — Record Keeping and Archiving of Documents NEW EMA/INS/GCP/183077/2022 INSPECTION PROCEDURE 2022 PDF · 244 KB EMA Guidance for Applicants/MAHs Involved in GCP Inspections Coordinated by EMA NEW GUIDANCE 2022 PDF · — MHRA Oversight and Monitoring of Investigational Medicinal Product Trials Under Review GUIDANCE 2022 HTML · 480 KB NMPA Work Procedures for Drug Registration Inspection (Trial) NEW CFDI No. 30 of 2021, Attachment 1 INSPECTION PROCEDURE 2021 PDF · — HC Risk Classification Guide of Observations Related to Clinical Trial Inspections NEW Under Review GUI-0043 GUIDANCE 2021 HTML · — NMPA E6(R3) GCP Guideline Implementation Recommendations CDE, August 2025 GUIDANCE 2025 PDF · 820 KB NMPA Good Clinical Practice for Drug Clinical Trials (2020 Revision) No. 57 REGULATION 2020 PDF · 1.4 MB PMDA Ministerial Ordinance on Good Clinical Practice for Drugs (J-GCP) MHLW Ord. 28 REGULATION 2020 LINK · — NMPA Provisions for Drug Registration REGULATION 2020 LINK · — NMPA Drug Administration Law of the People's Republic of China (2019 Revision) NEW Presidential Order No. 31 REGULATION 2019 HTML · — ICH E9(R1) Statistical Principles for Clinical Trials — Estimands Addendum E9(R1) GUIDELINE 2019 PDF · 780 KB ICH E8(R1) General Considerations for Clinical Studies E8(R1) GUIDELINE 2019 PDF · 900 KB ICH E17 General Principles for Planning and Design of Multi-Regional Clinical Trials NEW E17 GUIDELINE 2017 PDF · — EMA Guideline on Strategies to Identify and Mitigate Risks for First-in-Human and Early Clinical Trials EMEA/CHMP/SWP/28367/07 Rev. 1 GUIDANCE 2017 PDF · 580 KB ICH E6(R2) Good Clinical Practice — Superseded Superseded E6(R2) GUIDELINE 2016 PDF · 2.0 MB EMA Regulation (EU) No 536/2014 on Clinical Trials on Medicinal Products for Human Use NEW EU 536/2014 REGULATION 2014 LINK · — FDA Electronic Source Data in Clinical Investigations GUIDANCE 2013 PDF · 380 KB FDA Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring GUIDANCE 2013 PDF · 720 KB ICH E2F Development Safety Update Report NEW E2F GUIDELINE 2011 PDF · — EMA Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools REFLECTION PAPER 2010 PDF · 420 KB FDA Computerized Systems Used in Clinical Investigations GUIDANCE 2007 PDF · 420 KB ICH E3 Structure and Content of Clinical Study Reports E3 GUIDELINE 1995 PDF · 1.0 MB ICH E2A Clinical Safety Data Management — Definitions and Standards for Expedited Reporting E2A GUIDELINE 1994 PDF · 480 KB
§ 02 — Agency portals
Entry points to each regulator's own GCP hub. These are navigation pages on the agency site — not documents — so they open externally. The guidance behind them is catalogued above as it's added.
EMA European Medicines Agency opens on ema.europa.eu ↗ HC Health Canada opens on canada.ca ↗ MHRA Medicines & Healthcare products Regulatory Agency opens on gov.uk ↗ NMPA National Medical Products Administration opens on nmpa.gov.cn ↗ PMDA Pharmaceuticals & Medical Devices Agency opens on pmda.go.jp ↗ FDA U.S. Food & Drug Administration opens on fda.gov ↗