Canadian Drug Regulations

08 Jul 2026

Industry Insight: June 2026 Update: Health Canada Discusses GMP Inspection Trends, Quality System Expectations, and Compliance Priorities for DEL

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On Tuesday June 23, 2026, at the Pharmaceutical Sciences Group’s (PSG) 9th Annual Day with Health Canada, Karolina Zarichna from Source Nutraceutical, Inc. (SNI) attended discussions on recent Good Manufacturing Practices (GMP) inspection trends and compliance expectations for Canadian and foreign drug establishments. Health Canada provided insight into inspection observations…

04 Sep 2025

Health Canada Adds New Ingredients to the Prescription Drug List

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Health Canada has announced updates to the Prescription Drug List (PDL) that affect both human and veterinary drugs. This amendment introduces four new medicinal ingredients that now require a prescription and revises the conditions under which benzoyl peroxide is considered prescription-only for human use. These changes are effective immediately as…

20 May 2025

April 2025 Additions to Health Canada’s Prescription Drug List (PDL): What You Need to Know

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When most people think about prescription drugs, they may not consider the regulatory framework that determines which medicines are available only by prescription. But in Canada, this distinction is critically important and tightly governed by Health Canada through its Prescription Drug List (PDL). In a recent regulatory update published on…

15 May 2025

How to License a Sunscreen Product in Canada — Step-by-Step for NHPs and NPDs

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Sunscreen is more than a summertime staple; it's a frontline defence against premature aging, sunburn, and skin cancer. As consumer awareness around sun protection continues to grow, so does the demand for innovative, high-quality sunscreen products. But behind every tube on a drugstore shelf lies a rigorous regulatory journey. In…

13 May 2025

How to Get a Drug Identification Number (DIN) in Canada — A Guide for Importers and Manufacturers

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Entering the Canadian pharmaceutical market requires more than just a good product—it requires regulatory approval. If you’re planning to sell prescription drugs, over-the-counter medications, medicated shampoos, or sunscreens in Canada, you’ll need a Drug Identification Number (DIN) issued by Health Canada. The DIN is not just a tracking number; it’s…

08 May 2025

Understanding Sunscreen Licensing in Canada — Regulatory Pathways and Health Canada’s Role

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Over the years, research has consistently highlighted just how important sunscreen is in a daily skincare routine. Some people were ahead of the curve, protecting their skin from harmful UV rays long before sunscreen became a non-negotiable part of everyone’s morning regimen. But what many don’t realize is that bringing…

05 Jul 2023

UPDATES: Natural Health Product Plain Language Labelling

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We mentioned in September that there are changes in the near future regarding labelling of natural health products in Canada, and with an implementation date of June 21, 2025, we are revisiting the requirements to help the industry prepare. For products already on the market, or those which will have…

29 Jun 2023

Health Canada’s Proposal for NHP Cost Recovery Causes Waves

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The Canadian regulations for Natural Health Products (NHPs) came into force in 2004, and for nearly 20 years, Canadians have been able to shop with confidence for products displaying either a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the product label. These products must be approved by…