QMS

Health Canada to Implement ICH E6(R3): What It Means and How to Prepare

28

Oct

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Clinical TrialsClinical Research, Clinical Trial Oversight, Clinical trials, Critical to Quality, CRO, CtQ Factors, GCP, Good Clinical Practice, health canada, Health Canada guidelines, ICH E6(R3), Investigators, QMS, quality management system, Regulatory Compliance, Regulatory Update, Research Ethics Boards, Risk-Based Quality Management, Sponsors

Health Canada to Implement ICH E6(R3): What It Means and How to Prepare

On October 17th, Health Canada has confirmed it will implement the ICH E6(R3) Good Clinical Practice (GCP) guideline, a major international update to the way clinical trials are designed, managed, and documented. The goal is to strengthen participant safety, improve data quality, and modernize how clinical research is conducted in Canada. …

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Health Canada’s 2025 Update to the GMP Guide (GUI-0158) for Natural Health Products – What’s New in Version 4.0 and How to Comply

23

Sep

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NHPsBatch Records, canadian regulations, CAPA, consulting experts, Data Integrity, Foreign Site Reference Number, FSRN, GMP, GUI-0158, health canada, Health Canada inspections, master production documents, natural health products, NHP, NHP importing, NHP manufacturing, QAP responsibilities, QMS, quality management system, quality risk management, quality systems, Regulatory Compliance, site licensing, stability programs, supplier qualification

Health Canada’s 2025 Update to the GMP Guide (GUI-0158) for Natural Health Products – What’s New in Version 4.0 and How to Comply

Adhering to good manufacturing practices (GMP) is a cornerstone of regulatory compliance for companies in the natural health product (NHP) industry. In Canada, GMP requirements are outlined in Health Canada’s Good manufacturing practices guide for natural health products (GUI-0158), which supports Part 3 of the Natural Health Products Regulations. The…

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