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2025 GMP Overhaul for Natural Health Products (NHPs): What It Means for Canadian Importers and Site Licence Holders

18

Nov

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Site LicensingCAPA, GMP compliance, GUI-0158, health canada, Importer Requirements, natural health products, quality management system, Site Licence, Validation and Stability Testing

2025 GMP Overhaul for Natural Health Products (NHPs): What It Means for Canadian Importers and Site Licence Holders

A New Era of GMP Accountability for Natural Health Products When Health Canada released Version 4.0 of the Good manufacturing practices guide for natural health products (GUI-0158) on September 4, 2025, it marked the first major revision of good manufacturing practices (GMP) expectations in a decade. The new guide, which…

Understanding MDSAP and Its Role in Canadian Market Access

30

Oct

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Medical DevicesFood and Drugs Act, health canada, ISO 13485, ISO 13485:2016, MDL Canada, MDSAP, MDSAP audit, MDSAP audit cycle, MDSAP audit process, MDSAP Canada, MDSAP certification, Medical Device Licence, Medical Device Single Audit Program, Medical Devices Regulations

Understanding MDSAP and Its Role in Canadian Market Access

The Medical Device Single Audit Program (MDSAP), developed by the International Medical Device Regulators Forum (IMDRF), is a harmonized audit framework that allows a single ISO 13485:2016 audit, conducted by an approved Auditing Organization (AO), to meet the quality management system (QMS) requirements of multiple regulatory authorities simultaneously. In Canada, MDSAP serves as the recognized mechanism…

Health Canada to Implement ICH E6(R3): What It Means and How to Prepare

28

Oct

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Clinical TrialsClinical Research, Clinical Trial Oversight, Clinical trials, Critical to Quality, CRO, CtQ Factors, GCP, Good Clinical Practice, health canada, Health Canada guidelines, ICH E6(R3), Investigators, QMS, quality management system, Regulatory Compliance, Regulatory Update, Research Ethics Boards, Risk-Based Quality Management, Sponsors

Health Canada to Implement ICH E6(R3): What It Means and How to Prepare

On October 17th, Health Canada has confirmed it will implement the ICH E6(R3) Good Clinical Practice (GCP) guideline, a major international update to the way clinical trials are designed, managed, and documented. The goal is to strengthen participant safety, improve data quality, and modernize how clinical research is conducted in Canada. …

23

Oct

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Cosmeticsbilingual labelling, Bill 96, CNF, consumer protection, Cosmetic Ingredients, cosmetic labelling, Cosmetic Packaging, cosmetic regulations, Cosmetic Safety, health canada, INCI, Label Design Canada, Regulatory Compliance

Cosmetic Labelling in Canada: What You Need to Know

When introducing a new cosmetic product to the Canadian market, manufacturers and importers must meet several key regulatory obligations. Products must contain only safe ingredients that are permitted for cosmetic use, be properly notified to Health Canada through a Cosmetic Notification Form (CNF), and display labels that fully comply with…

25

Sep

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Clinical TrialsCanadian regulation, clinical governance, GCP, health canada, natural health products, NHP clinical trials, NNHPD, portfolio assessment

NHP Clinical Trials – Feasibility and Portfolio Assessment

Clinical trials for natural health products (NHPs) such as vitamins, herbal remedies, and probiotics bring scientific rigour to traditional health claims. In Canada, where consumer protection and evidence-based regulation are priorities, sponsors are beginning to shift away from running isolated trials toward building comprehensive clinical research strategies. This shift reflects…

Health Canada’s 2025 Update to the GMP Guide (GUI-0158) for Natural Health Products – What’s New in Version 4.0 and How to Comply

23

Sep

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NHPsBatch Records, canadian regulations, CAPA, consulting experts, Data Integrity, Foreign Site Reference Number, FSRN, GMP, GUI-0158, health canada, Health Canada inspections, master production documents, natural health products, NHP, NHP importing, NHP manufacturing, QAP responsibilities, QMS, quality management system, quality risk management, quality systems, Regulatory Compliance, site licensing, stability programs, supplier qualification

Health Canada’s 2025 Update to the GMP Guide (GUI-0158) for Natural Health Products – What’s New in Version 4.0 and How to Comply

Adhering to good manufacturing practices (GMP) is a cornerstone of regulatory compliance for companies in the natural health product (NHP) industry. In Canada, GMP requirements are outlined in Health Canada’s Good manufacturing practices guide for natural health products (GUI-0158), which supports Part 3 of the Natural Health Products Regulations. The…

Health Canada’s 2025 Red Tape Reduction Plan: What You Need to Know

18

Sep

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NHPscanadian regulations, health canada, innovation, public health, Public Health Agency of Canada, red tape reduction, regulatory modernization, regulatory reform, risk-based regulation, trade barriers

Health Canada’s 2025 Red Tape Reduction Plan: What You Need to Know

Cutting red tape is at the heart of Health Canada and the Public Health Agency of Canada’s new regulatory modernization plan. In July 2025, the Government of Canada launched a federal Red Tape Review to address growing concerns that outdated, duplicative, and overly complex rules are slowing market access, discouraging…

New and Upcoming FDA Changes in 2025: GRAS Rules, FOP Labelling, and Supplement Ingredients – What You Need to Know

16

Sep

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FDAcanadian regulations, cross-border compliance, dietary supplements, DSHEA, FDA, FDA Unified Agenda, food labelling, FOP labelling, front-of-package labelling, GRAS, health canada, ingredient safety, NHP, nicotinamide mononucleotide, NMN, novel foods, Nutrition Labelling, Regulatory Affairs, self-affirmed GRAS, U.S. regulations

New and Upcoming FDA Changes in 2025: GRAS Rules, FOP Labelling, and Supplement Ingredients – What You Need to Know

On September 4, 2025, the U.S. Food and Drug Administration (FDA) published its Unified Regulatory Agenda, a key planning document that outlines the Agency’s top priorities over the coming year. Among the many proposed and final rules, three initiatives stand out for their potential to significantly impact food and dietary…

Chewing Gum Exemption for “Free of Sugars” Claim Reinstated

09

Sep

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FoodCanadian food industry, canadian regulations, chewing gum, compliance, food labelling, free of sugars, health canada, low in energy, nutrient content claims, Regulatory Update

Chewing Gum Exemption for “Free of Sugars” Claim Reinstated

On September 2, 2025, Health Canada updated the Table of Permitted Nutrient Content Statements and Claims, modifying the table to once again exempt chewing gum from the energy conditions set out under the “free of sugars” claim. Learn more about this regulatory change and what it means for manufacturers and…

Health Canada Adds New Ingredients to the Prescription Drug List

04

Sep

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

Health Canada Adds New Ingredients to the Prescription Drug List

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…