Drugs - SNI Inc.

27 Aug 2026

Health Canada Updates Natural Health Product (NHP) Labelling Terms

Canadian Drug Regulations, Natural Health Products (NHPs), NHP Regulationscanadian regulations, health canada, interchangeable terms, natural health products, NHP claims, NHP Labelling, non-prescription drugs, product label compliance

Health Canada has expanded the labelling flexibility available to natural health products (NHPs) and certain non-prescription drugs through an updated List of Interchangeable Terms. Announced in Natural Health Product Licensing Bulletin No. 12 on August 20, 2026, the update allows companies to use clearer or more consumer-friendly language without necessarily changing the meaning…

28 Jul 2026

Health Canada Proposes a Streamlined Pathway for Certain Low-Risk Non-Prescription Drugs

DrugsCanadian drug regulations, DIN application Canada, Division 1 drug application, Division 8 new drug, Drug Identification Number Canada, Health Canada drug monographs, Health Canada List D, Health Canada non-prescription drugs, non-prescription drug authorization Canada, over-the-counter drugs Canada

Health Canada is proposing a streamlined authorization pathway for certain low-risk non-prescription drugs in Canada. Eligible List D products that fully comply with an applicable Health Canada monograph could be exempted from Division 8 “new drug” requirements and instead apply for a Drug Identification Number (DIN) under Division 1. The proposal may…

14 Jul 2026

Industry Insight: June 2026 Update: Health Canada Provides Updates on Human Drug Submission Workload Management

Canadian Drug RegulationsCanadian pharmaceuticals, drug submissions, health canada, Health Canada Updates, market access, pharmaceutical regulations, regulatory modernization, Regulatory Strategy, submission backlog

As of June 2026, Health Canada is advancing workload management measures intended to address human drug submission backlogs, improve review predictability, and support more transparent communication with sponsors. These measures include enhanced communication protocols, expanded reliance approaches, HTA alignment, and operational review efficiencies, while maintaining Health Canada’s review standards for…

08 Jul 2026

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

Canadian Drug RegulationsCAPA Management, Drug Establishment Licence, Drug Establishment Licensing, Foreign Site Inspections, GMP Inspections Canada, Good Manufacturing Practices, Health Canada compliance, Health Canada GMP, Pharmaceutical Quality Systems

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…

02 Jun 2026

Health Canada Melatonin Update: Pediatric Use to Become Prescription-Only

DrugsFood and Drug Regulations, health canada, Melatonin, natural health products, NHP compliance, Pediatric Melatonin, Pediatric Sleep Products, Prescription Drug List, regulatory affairs Canada

Health Canada has announced an amendment to the human use section of the Prescription Drug List for “melatonin or its salts.” Effective June 2, 2026, melatonin products sold for sleep-related use in children and adolescents under 18 years of age will be classified as prescription drugs under the Food and Drug…

04 Sep 2025

Health Canada Adds New Ingredients to the Prescription Drug List

Canadian Drug Regulationsartesunate, benzoyl peroxide, canadian regulations, crovalimab, health canada, osilodrostat, PDL update, Pharmaceutical compliance, Prescription Drug List, prescription drugs, quizartinib, Regulatory Affairs

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

Canadian Drug Regulationsdrug regulation, efanesoctocog alfa, fecal microbiota, health canada, inavolisib, loncastuximab tesirine, PDL, Prescription Drug List, retifanlimab, rozanolixizumab, sipavibart, tofersen, vaborbactam

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

Canadian Drug Regulations, Drugs, Natural Health Products (NHPs), NHP RegulationsCanadian Cosmetic Regulations, Canadian Sunscreen Compliance, Health Canada Licensing, Health Canada Regulations, NHP vs NPD Sunscreens, SPF Claims Canada, Sunscreen Approval Canada, Sunscreen Import Requirements, Sunscreen Labelling Requirements, Sunscreen Licensing, Sunscreen Product Licensing

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

Canadian Drug RegulationsCanadian drug regulations, DIN application process, DIN Canada, Drug Identification Number, drug import Canada, drug labelling Canada, GMP compliance Canada, Health Canada DEL, Health Canada drug approval, how to get a DIN, pharmaceutical compliance Canada, sell drugs in Canada

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

Canadian Drug Regulations, Natural Health Products (NHPs)Canadian Sunscreen Compliance, Health Canada Regulations, NHP vs NPD Sunscreens, Sunscreen Approval Canada, Sunscreen Licensing

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…