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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 This is an archive — not current guidance or medical advice. Archived content may be incomplete, outdated, or superseded.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.
For background on coverage and capture methods, see Methods & coverage.
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Certified Product Information Document – Biologics (Schedule D drugs) (CPID-B (Schedule D drugs)) in the CTD Format This template is an HTML representation of the form and it is not meant to be completed. To request a copy of the fillable form, please contact…
Guidance for Sponsors: Lot Release Program for Schedule D (Biologic) Drugs (PDF Version - 138 K) Contact: Regulatory Affairs Division Date: 2005-06-01 Table of Contents 1.0 Introduction 1.1 Purpose 1.2 The Lot Release Program 1.3 Scope 1.4 Abbreviations, Acronyms, and Definitions…
Guidance document on the application for a certificate of a pharmaceutical product and good manufacturing practice certificate (GUI-0024) - Summary GUI-0002 GUI-0001 GUI-0080 Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce…
Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products - Guidance Document for Industry ( PDF version ) PUB No.:180054 Catalogue No.: H164-235/2018E-PDF ISBN: 978-0-660-26506-3 Effective date: May 23, 2018 Foreword Guidance documents are meant to…
Annex 3A to the Good manufacturing practices guide - Schedule C drugs (GUI-0026): Overview Date implemented: July 04, 2024 Replaces: Guidance Document Annex 3 to the Current Edition of the Good Manufacturing Practices Guidelines - Schedule C Drugs (GUI-0026) , November 19, 2010…
Summary of Annex 3B to the Good manufacturing practices guide – Positron-emitting radiopharmaceuticals Good manufacturing practices guide for drug products (GUI-0001) Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (API) - (GUI-0104) Annex 3A to the Good…
Guidance Document Alternate Sample Retention Site Guidelines (GUI-0014) This guidance has been archived. Updated content for GUI-0014 is included in: How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080) . This HTML document is not a…
Guidance Documents – Good Manufacturing Practices On this page Active Pharmaceutical Ingredients Biologics / Blood Canada's Access to Medicines Regime (CAMR) Clinical Trials - Manufacturing GMPs Computers Compounding Consultation Establishment Licences Foreign Sites General Good…
Draft Guidance Document: The Use of Foreign Reviews by Health Canada and revisions to the Use of Foreign Reviews pilot project The online consultation is now closed. The content found on this page is a snapshot of the live consultation as it was presented to the public and…
Guidance Document: Reconsideration of Decisions Issued for Human Drug and Natural Health Product Submissions Download the alternative format (PDF format, 627 KB, 33 pages) May 2019 ISBN: 978-0-660-30497-7 (PDF) Cat.: H14-318/2019E-PDF HC Pub.: 190002 Organization: Health Canada…
Early release: coverage is bounded to the current corpus, and features may change.
