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Navigating UK Pharmacovigilance Requirements for Natural Health Products: A Comprehensive Guide for Canadian Manufacturers
The UK dietary supplements market was valued at approximately USD 4.79 billion in 2024 and is projected to reach nearly USD 9.65 billion by 2033, growing at around 8.1% annually. A sophisticated, health-conscious consumer base, with the most positive attitude toward supplements in Europe, makes the UK genuinely compelling for Canadian NHP manufacturers looking beyond North America. But Brexit fundamentally restructured how natural health products are regulated in Great Britai
Jul 125 min read
Post marketing safety surveillance Requirements for Natural Health Products in Japan: A Guide for Canadian Manufacturers
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
Jun 224 min read
Health Canada’s May 2026 GVP Update: The Hidden Wake-Up Call for Natural Health Products (NHPs)
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
Jun 73 min read
Pharmacovigilance Requirements for Natural Health Products in the European Union: What Canadian Manufacturers Need to Know
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
May 316 min read


Pharmacovigilance for Natural Health Products in Canada: Regulatory Requirements and Building a Compliant System
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
May 248 min read


ADVERSE EVENT REPORTING FOR CANNABIS LICENCE HOLDERS. A guide to compliance in Canada
The Canadian cannabis industry has entered a new phase of maturation since its federal legalization. This phase is marked by heightened regulatory scrutiny and an increasing focus on consumer safety. For cannabis licence holders, especially small and medium-sized enterprises (SMEs), navigating the complex requirements for post-market surveillance and adverse event (AE) reporting is a significant challenge. Non-compliance with Health Canada's regulations can expose businesses
Nov 20, 20257 min read
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