Workshop Overview
In this workshop, attendees will learn how Natural Health Products are managed beyond initial approval, including Canadian requirements for importation, exportation, distribution, master files, clinical trials, and adverse reaction reporting. The content further covers importer and exporter responsibilities, exemptions for personal use and clinical trials, the role of master files in protecting proprietary ingredient information, and when clinical trial authorization is required. Attendees are also introduced to international regulatory frameworks, comparing Canada’s pre-market approval system with U.S. dietary supplement regulation under DSHEA and post-market oversight by the FDA. Together, this content provides a practical understanding of global compliance obligations, evidence expectations, claims oversight, and safety monitoring across the full lifecycle of health products.
Who Should Attend
This webinar is intended for students and professionals who work with, or plan to work with, Natural Health Products and dietary supplements and need a practical understanding of post-market and global regulatory requirements. It is particularly relevant for individuals in regulatory affairs, quality assurance, product development, manufacturing, import/export, compliance, and clinical research roles, as well as consultants, ingredient suppliers, importers, exporters, and distributors. The webinar is also well suited for students in life sciences, nutrition, health sciences, pharmaceutical sciences, or regulatory affairs programs, and for professionals seeking exposure to U.S. frameworks to support international market access and ongoing compliance.
Learning Outcomes
By the end of this workshop, participants will be able to:
- Explain Canadian post-market regulatory requirements for Natural Health Products, including importation, exportation, distribution, exemptions for personal use and clinical trials, and the responsibilities of licence holders and importers.
- Describe the purpose and structure of Natural Health Product Master Files including how proprietary ingredient information is protected, when master files are used, and how they support product licence and clinical trial applications.
- Identify when clinical trial authorization is required for NHPs, distinguish between clinical trial phases, and explain Health Canada’s requirements for clinical trial applications, ethics approval, and adverse reaction reporting.
- Apply adverse reaction and pharmacovigilance requirements, including differentiating adverse events from adverse reactions, recognizing serious and unexpected reactions, and understanding reporting timelines and obligations.
- Compare international regulatory frameworks for health products including Canada’s pre-market approval system, U.S. dietary supplement regulation under DSHEA and FDA oversight, to assess global compliance considerations.
All participants will receive a certificate of attendance upon completion of the workshop.
