GCP

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

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. …

Sep

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Clinical TrialsCanadian regulation, clinical governance, GCP, health canada, natural health products, NHP clinical trials, NNHPD, portfolio assessment

NHP Clinical Trials – Feasibility and Portfolio Assessment

Clinical trials for natural health products (NHPs) such as vitamins, herbal remedies, and probiotics bring scientific rigour to traditional health claims. In Canada, where consumer protection and evidence-based regulation are priorities, sponsors are beginning to shift away from running isolated trials toward building comprehensive clinical research strategies. This shift reflects…