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Introduction The Japanese market for natural health products (NHPs) represents a significant opportunity for Canadian manufacturers, but it is also one of the most regulated globally. Japan’s pharmacovigilance framework is rigorous, reflecting the country’s high standards for drug safety, quality, and efficacy. For Canadian NHP manufacturers seeking to export to Japan, understanding the regulatory framework, key agencies involved, and specific pharmacovigilance requirements i

On May 22, 2026, Health Canada rolled out an extensive, synchronized update to its foundational Good Pharmacovigilance Practices (GVP) framework. Replacing standard documentation that hadn't seen a major refresh since 2013, these updates refine how drug safety data is captured, how inspections are carried out, and how GVP-related risks are classified. For pharmaceutical and biologic manufacturers, the changes clarify expectations. But for Natural Health Product (NHP) manufact

The European Union(EU) is the world's second-largest pharmaceutical market, with the herbal medicines segment alone projected to reach USD 89 billion by 2029. For Canadian manufacturers of Natural Health Products (NHPs), expansion into the European Union can be commercially attractive, but it is rarely straightforward from a regulatory standpoint. The challenge is not simply one of product registration. It is one of classification, governance, post-market accountability, and

Securing a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) from Health Canada is a major milestone, but it marks the beginning of a product's life cycle, not its end. The day your Natural health product (NHP) becomes available for sale in Canada is the day your post-market safety obligations under the Natural Health Products Regulations (SOR/2003-196) begin to run. For NHP licensees, these obligations are anchored in Section 24 of the Regulations and oper