Health Canada guidelines

28 Oct 2025

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

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

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

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. …

Read More

21 Feb 2025

Natural Health Products Regulations – Overview and Guidance for Canadian Market Entry

Natural Health Products Regulations – Overview and Guidance for Canadian Market Entry

NHPsbilingual labelling, Canadian health products, Canadian regulatory affairs, GMP compliance, Health Canada approval, Health Canada guidelines, Health Canada NPN, natural health products, Natural Product Number, NHP application process, NHP clinical evidence, NHP compliance, NHP labelling requirements, NHP market entry, NHP Regulations Canada, NHP site licence, product licensing, site licensing, supplement regulations Canada

Navigating the complex and ever-evolving landscape of Natural Health Products Regulations (NHPR) in Canada is crucial for businesses hoping to enter the Canadian market. Canada offers a significant market opportunity for companies, similar to the U.S., but success depends on a thorough understanding of the regulatory requirements. Ensuring compliance with…

Read More