June 2025 is fast approaching! This is the day that the new Biocides Regulations take effect. And that means that this is day that the regulatory environment changes significantly for...
As part of its Forward Regulatory Plan (2024-2026), Health Canada is modernizing the Medical Device Establishment Licensing (MDEL) framework. This modernization effort aims to enhance regulatory oversight while reducing unnecessary...
What is Quality Assurance? Quality Assurance (QA) is a systematic, planned approach to ensure that products meet strict quality standards and are free from defects. It emphasizes the processes and...
The Pest Management Regulatory Agency (PMRA) plays a crucial role in ensuring the safe use of pest control products in Canada under the Pest Control Products Act. Through regularly updated...
By: Jackie Menzies Yarnton, PRINCIPAL REGULATORY CONSULTANT, email Introduction Earlier this year, Health Canada moved the review of NHP site licenses from the Health Products and Food Branch (which covers...
By: By: Jackie Menzies Yarnton, PRINCIPAL REGULATORY CONSULTANT, email In recent months, Canada has seen significant developments regarding the legislative landscape for natural health products (NHPs). Bill C-368, introduced by...
By: Matthew Lai, REGULATORY SPECIALIST, email Understanding NHP GMPs What are NHP GMPs? Good Manufacturing Practices (GMPs) are the set of guidelines and principles that all manufacturers should follow when...
By: Ivy Tang, PRINCIPAL REGULATORY CONSULTANT, email The Cosmetic Notification Form (CNF) is a regulatory requirement in Canada designed to ensure that cosmetics comply with safety standards outlined in the...
By: Steve McCarthy, DIRECTOR OF REGULATORY AFFAIRS, email Published: July 9, 2024 – Drug Establishment Licensing Bulletin 174 In early 2024, Health Canada lifted the temporary measures that allowed the...
By: Ivy Tang, PRINCIPAL REGULATORY CONSULTANT, email Understanding the Natural Health Products Regulations in Canada Navigating the landscape of Natural Health Products (NHPs) in Canada requires a thorough understanding of...
By: Joanna Chudyk, SENIOR REGULATORY AFFAIRS SPECIALIST, email The Natural and Non-prescription Health Products Directorate (NNHPD) has announced updates in their Batch 4a consultation: new monographs for Sports Electrolyte Supplements...
By: By: Ivy Tang, PRINCIPAL REGULATORY CONSULTANT, email Introduction In Canada, the intended use of a medical device primarily determines its class. Classification must be consistent with the claims that...
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