Health Canada Finalizes Version 4.0 of NHP GMP Guidance (Effective March 4, 2026)

Health Canada unveiled the finalized version of its Good Manufacturing Practices Guide (GUI-0158, Version 4.0) for Natural Health Products. The updated guidance includes clearer structure, enhanced quality system requirements (e.g., quality manuals, executive oversight), explicit applicability across the entire supply chain (including distributors and e-commerce storage), strengthened roles for Quality Assurance Persons (QAP), expanded record-keeping, stability programs, CAPA procedures, and mock recall protocols. A six-month transition period runs until March 4, 2026.