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Drugs and Health Products
Drug Products
Current Consultations
- Release of the Draft Guidance Document: Guidance Document for Clinical Trial Sponsors - Clinical Trial Applications [2011-11-07]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- Draft Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Market Entry Inhaled Corticosteroid Products for Use in the Treatment of Asthma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]
- Draft Guidance Document - The Use of Foreign Reviews by Health Canada [2011-09-09]
- A blank Foreign Review Attestation template is available in Microsoft™ Word® upon request. To receive a blank Foreign Review Attestation template, please contact the Use of Foreign Regulatory Information Steering Committee at UFRI_URRE@hc-sc.gc.ca.
Past Consultations
2011
- 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- Revised Draft Guidance Document Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format [2011-08-08]
- Draft Guidance Document - Product Monograph - Part III: Consumer Information [2011-07-21]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- Draft Guidance Document - Post-Notice of Compliance Changes: Quality Document - Appendix I [2011-03-21]
- Draft Guidance Document - Hepatotoxicity of Health Products [2011-02-16]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- Draft Guidance Document - Labelling of Pharmaceutical Drugs for Human Use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
2009
- Food and Drug Regulations - Project 1656 - Schedule F
- Food and Drug Regulations - Project 1577 - Schedule F
- Food and Drug Regulations - Project 1651 - Schedule F
- Food and Drug Regulations - Project 1652 - Schedule F Amendment
- Food and Drug Regulations - Project 1596 - 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: S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals [2009-12-07]
- Consultation - Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Annex 12 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving 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 11 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter
- Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Document: E7: Studies in Support of Special Populations - Geriatrics Questions and Answers
- Food and Drug Regulations - Project 1597 - Schedule F Amendment [2009-09-30]
- Food and Drug Regulations - Project 1623 - Schedule F Amendment [2009-09-24]
- Consultation - Draft Guidance Document Non-Clinical Laboratory Study Data Supporting Clinical Trial Applications, New Drug Submissions and Drug Identification Number Applications: Adherence to Good Laboratory Practices [2009-08-27]
- Consultation - Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Annex 10 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter [2009-08-24]
- Consultation - Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Annex 9 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter [2009-08-24]
- Consultation - Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: E16: Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions [2009-10-09]
- Food and Drug Regulations - Project 743 - Non-Medicinal Ingredients Labelling (NMI) [2009-06-08]
- Food and Drug Regulations - Project 1595 - Schedule F [2009-05-20]
- Consultation on the Release of Draft Revisions to Health Canada's Guide for the Analysis and Review of QT/QTc Interval Data [2009-05-11]
- Consultation on the Release of Draft Revisions to Health Canada's QT/QTc Interval Prolongation: Guidance for Product Monograph Content [2009-05-06]
- Consultation on the Release of a draft revised Health Canada 3011: Drug Submission Application Form for Human, Veterinary, Disinfectant Drugs and Clinical Trial Application/Attestation [2009-05-01]
- Food and Drug Regulations - Project #1594 - Schedule F Amendment [2009-04-14]
- Consultation - Evaluation of Phase I of the Summary Basis of Decision Initiative [2009-04-08]
- Consultation - Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Annex 6 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Uniformity of Dosage Units 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 7 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution 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 8 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility 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: ICH S9 - Nonclinical Evaluation for Anticancer Pharmaceuticals
- Consultation - Draft Guidance Document Acetaminophen Labelling Standard
