CA · Regulatory Operations

HC

Health Canada

3 documents in the Library — regulations, inspection procedures, guidance, Q&As, and reflection papers.

§ 01 — Agency portal

AGENCY PORTAL · HC Health Canada — GCP Compliance and Enforcement The agency's own GCP hub — navigation and resources beyond the documents catalogued below.

opens on canada.ca ↗

§ 02 — Documents

HC Food and Drug Regulations — Division 5 (Clinical Trials) C.05 REGULATION 2024 LINK · — HC Good Clinical Practices — Inspection Guidance GUI-0100 GUIDANCE 2023 PDF · 2.7 MB HC Risk Classification Guide of Observations Related to Clinical Trial Inspections NEW Under Review GUI-0043 GUIDANCE 2021 HTML · —