EU · GCP Inspectors Working Group
EMA
European Medicines Agency
18 documents in the Library — regulations, inspection procedures, guidance, Q&As, and reflection papers.
§ 01 — Agency portal
AGENCY PORTAL · EMA EMA Good Clinical Practice (GCP) Inspection Procedures
The agency's own GCP hub — navigation and resources beyond the documents
catalogued below.
opens on ema.europa.eu ↗ § 02 — Documents
EMA Annual Report of the Good Clinical Practice Inspectors Working Group 2024 NEW EMA/INS/GCP/37608/2025 ANNUAL REPORT 2024 PDF · — EMA Recommendation Paper on Decentralised Elements in Clinical Trials GUIDANCE 2025 PDF · — EMA ICH E6(R3) Good Clinical Practice — CHMP Adoption CHMP/ICH/135/1995 GUIDELINE 2025 PDF · 3.1 MB EMA Reflection Paper on Risk-Based Quality Management in Clinical Trials REFLECTION PAPER 2025 PDF · 1.2 MB EMA Mutual Reliance Initiative for GCP Inspections (EU–FDA) NOTICE 2024 HTML · — EMA Reflection Paper on Use of Artificial Intelligence in the Medicinal Product Lifecycle REFLECTION PAPER 2024 PDF · 1.1 MB 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 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 · — EMA Guideline on Computerised Systems and Electronic Data in Clinical Trials EMA/INS/GCP/112288/2023 GUIDANCE 2023 PDF · 1.8 MB 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 · — 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 EMA Regulation (EU) No 536/2014 on Clinical Trials on Medicinal Products for Human Use NEW EU 536/2014 REGULATION 2014 LINK · — EMA Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools REFLECTION PAPER 2010 PDF · 420 KB