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Browse and search historical snapshots. This is an archive — not current guidance or medical advice. Archived content may be incomplete, outdated, or superseded. For up-to-date recommendations, always consult the official source website.

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International Coalition of Medicines Regulatory Authorities (ICMRA) Health Canada is collaborating with our international partners on issues related to drug and medical device clinical trials, authorizations, risk assessments, and potential shortages. Learn about how we are…

What We Heard Report – Stakeholder Consultation on the Naming of Biologic Drugs Download the alternative format (PDF format, 595 KB, 8 pages) Organization: Health Canada Type: Report Date published: 2019-02-14 Introduction Health Canada and the Institute for Safe Medication…

Biosimilar biologic drugs - Canada.ca

Health CanadaCaptures 11Latest capture Apr 11, 2026en

Biosimilar biologic drugs Download the alternative format (PDF format, 190 KB, 1 pages) Organization: Health Canada A biosimilar is a biologic drug (biologic) that is highly similar to another biologic previously authorized for sale. The biologic that is already authorized for…

Questions and Answers: Regulation of Medicinal Maggots / Medicinal Leeches What are medicinal maggots? What are medicinal leeches? Are medicinal maggots and leeches different from maggots and leeches found in a natural setting? Are medicinal maggots and leeches regulated by…

Post-Notice of Compliance Changes - Canada.ca

Health CanadaCaptures 12Latest capture Apr 11, 2026en

Post-Notice of Compliance Changes Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only) [2020-04-01] Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical,…

Questions and Answers Regarding the Implementation of a Risk-Prioritized Periodic Safety Update Report Regulatory Review Pilot (PSUR-RRP) at Health Canada Table of Contents What is a Periodic Safety Update Report (PSUR) and how is this tool used to enhance pharmacovigilance (PV)…

Yearly Biologic Product Report (YBPR) Template This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to use the form, you must use the alternate format below. Help on accessing alternative formats,…

Annex 2 to the Good manufacturing practices guide - Manufacture of biologics (GUI-0027): Overview Overview Quality risk management principles General guidance Guidance on product types Glossary and definitions References Date issued: 04-07-2024 Date implemented: 04-07-2024…

Overview of the good label and package practices guide for prescription drugs From: Health Canada Related acts and regulations Food and Drugs Act Canada Health Act Food and Drug Regulations Related program Drugs and Health Products Overview This best practices guide provides…

Quality Overall Summary – Biologic Products (QOS-B) Foreword The Quality Overall Summary (QOS) (Module 2.3) follows the scope and the outline of the Quality Body of Data (Module 3.2). This QOS-B template can be used by sponsors to summarize the Quality information for all types…

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