• Consultation - Draft Guidance Document: Disinfectant Drugs [2013-04-02]
• Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use Guidance: M7 - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk [2013-02-25]
• Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: ICH S10 - Photosafety Evaluation of Pharmaceuticals [2013-02-05]
• Consultation - International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) S1: Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals - Regulatory Notice for Public Input [2013-02-05]

• Consultation on the new Prescription Drug List [2012-12-24]
• Regulations Amending the Food and Drug Regulations (Project1688 - Arsenic Trioxide) [2012-12-17]
• Consultation on Health Canada's Public Clinical Trials Database [2012-12-13]
• Revised draft guidance document - sunscreen monograph [2012-11-21]
•  Regulations Amending the Food and Drug Regulations (1475 - Good Manufacturing Practices) [2012-09-29]
• Draft Guidance Document: Biopharmaceutics Classification System Based Biowaver - Comment period extended [2012-08-21]
• Draft Guidance Document: Acetylsalicylic Acid Labelling Standard [2012-07-27]

Past Consultations

2012

• Draft Guidance Document - The Use of Foreign Reviews by Health Canada - Updated - [2012-09-28]
• Consultation - Release of Draft (Step 2) International Conference on Harmonisation (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use Guidance: E2C(R2): Periodic Benefit Risk Evaluation Reports [2012-03-09]
• Food and Drug Regulations - Project # 1663 - Schedule F Amendment [2012-02-13]
• Draft Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) [2012-03-30]
• Draft Canadian Module 1 Schema Version 2.1 [2012-03-30]
• Draft Guidance for Industry: Creation of the Canadian Module 1 Backbone (eCTD) [2012-03-30]

2011

• Consultation - Proposed Changes to the Therapeutic Products Directorate's List of Recognized Standards [2011-11-23]
• Release of the Draft Guidance Document: Guidance Document for Clinical Trial Sponsors - Clinical Trial Applications [2011-11-07]
• Consultation on proposed Phase II of the Summary Basis of Decision Project [2011-10-19]
• Draft Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Market Entry Inhaled Corticosteroid Products for Use in the Treatment of Asthma [2011-09-19]
• Food and Drug Regulations - Project 1470 - Non-Medicinal Ingredient (NMI) Formulation [2011-10-17]
• Revised Draft Guidance Document Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format [2011-08-08]
• Draft Guidance Document - Product Monograph - Part III: Consumer Information [2011-07-21]
• Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Q11: Development and Manufacture of Drug Substance [2011-07-07]
• Food and Drug Regulations - Project # 1658 - Schedule F Amendment [2011-06-30]
• Food and Drug Regulations - Project # 1659 - Schedule F Amendment [2011-06-22]
• Food and Drug Regulations - Project # 1431 - Schedule F Amendment [2011-05-20]
• Draft Guidance Document - Post-Notice of Compliance Changes: Quality Document - Appendix I [2011-03-21]
• Draft Guidance Document - Hepatotoxicity of Health Products [2011-02-16]

2010

• Release of Draft Revisions to the Guidance Document - Notice of Compliance with Conditions
• Draft Guidance Document - Labelling of Pharmaceutical Drugs for Human Use
• Food and Drug Regulations - Project 1626 - Schedule F Amendment
• Consultation - Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Annex 14 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on: Bacterial Endotoxins Test General Chapter
• Consultation - Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Annex 13 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on: Bulk Density and Tapped Density of Powders General Chapter
• Food and Drug Regulations - Project Number 1621 - Schedule F Amendment
• Draft Guidance Documents - Conduct and Analysis of Comparative Bioavailability Studies; and Comparative Bioavailability Standards: Formulations used for Systemic Effects
• Food and Drug Regulations - Project 1627 - Schedule F Amendment
• Food and Drug Regulations - Project 1624 - Schedule F Amendment