CAPA for Natural Health Products (NHPs) in Canada: A Complete Technical Guide for GMP Compliance

CAPA for Natural Health Products (NHPs) in Canada: A Complete Technical Guide for GMP Compliance

Corrective and Preventive Actions (CAPA) sit at the centre of every strong and dependable quality system in the natural health product (NHP) space. Whether you manufacture, package, label, import, or distribute NHPs, in Canada or internationally, CAPA demonstrates that you can recognize issues early, correct them effectively, and establish controls that prevent them from recurring…
Read More
NHP Cost Recovery Paused: What NHP Companies Should Know

NHP Cost Recovery Paused: What NHP Companies Should Know

The natural health products (NHP) sector in Canada continues to evolve as Health Canada progresses toward a modernized, risk-based regulatory framework. Many industry stakeholders have been monitoring the proposed cost recovery initiative with a tentative target implementation date of December 1, 2025. Health Canada has confirmed that this implementation date…
Read More
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

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

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 In July 2025, the Government of Canada launched a federal Red Tape Review to address growing concerns that outdated, duplicative, and overly complex rules are slowing market access, discouraging…
Read More
What are the new NHP Monograph Updates? July 25, 2025 Revisions

What are the new NHP Monograph Updates? July 25, 2025 Revisions

On July 25, 2025, Health Canada published six new Natural Health Product (NHP) monographs, along with minor revisions to five existing monographs. These updates form part of Health Canada’s ongoing effort to align the Natural Health Products Ingredients Database (NHPID) and related monographs with the latest scientific evidence, safety considerations,…
Read More
Canada’s New Natural Health Product Labelling Rules: A High-level Overview

Canada’s New Natural Health Product Labelling Rules: A High-level Overview

The Canadian Natural Health Product (NHP) industry is preparing for one of its most significant regulatory shifts in nearly two decades. With the introduction of Health Canada’s new Plain Language Labelling (PLL) Regulations (Labelling for Natural Health Products), businesses that manufacture, distribute, or sell NHPs must rethink how their product…
Read More
Nicotine Tablets Now Non-Prescription in Canada: Health Canada Updates the Prescription Drug List 

Nicotine Tablets Now Non-Prescription in Canada: Health Canada Updates the Prescription Drug List 

Overview of the Prescription Drug List Change  On July 21, 2025, Health Canada implemented a regulatory amendment that exempts certain nicotine tablets from the human-use section of the Prescription Drug List (PDL). This change applies specifically to orally disintegrating and sublingual nicotine tablets that contain no more than 4 milligrams…
Read More
Natural Health Product (NHP) Regulations in Canada: A High-Level Overview for Businesses

Natural Health Product (NHP) Regulations in Canada: A High-Level Overview for Businesses

Canada’s growing wellness market presents a strong opportunity for companies looking to expand their product offerings, especially in the natural health space. But before launching any Natural Health Product (NHP), businesses must navigate Canada’s robust regulatory framework. Understanding the basics of NHP compliance is key to accessing the Canadian market,…
Read More
Health Canada Publishes Updated Natural Health Products Monographs – June 27, 2025 Update 

Health Canada Publishes Updated Natural Health Products Monographs – June 27, 2025 Update 

On June 27, 2025, Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) will release eight new monographs and revise three existing ones. These updates are part of Health Canada’s continued efforts to maintain regulatory guidance that is accurate, up to date, and reflective of current evidence and product trends. …
Read More
Quality Assurance Processes for Natural Health Products in Canada 

Quality Assurance Processes for Natural Health Products in Canada 

Quality assurance (QA) plays a central role in the safety and credibility of natural health products (NHPs) in Canada. Manufacturers are required to meet high standards set by Health Canada to ensure their products are safe, effective, and made with consistent quality before they reach the consumer.  Canada’s regulatory framework…
Read More