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Drugs and Health Products
Guidance Documents
Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing drug submissions when seeking an approval to sell a drug product in Canada.
- Guidance Document: Pre-market Evaluation of Hepatotoxicity in Health Products [2012-04-18]
- Draft Guidance Document: The Use of Foreign Reviews by Health Canada - update to Appendix 3 [2011-12-16]
- Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations [2011-10-11]
- Draft Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Market Entry Inhaled Corticosteroid Products for Use in the Treatment of Asthma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- Draft Guidance Document - The Use of Foreign Reviews by Health Canada [2011-09-09]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.
- Revised Draft Guidance Document Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format [2011-08-08]
- Notice Regarding Interim Approach for Evaluating Cardiovascular Risk for New Antidiabetic Therapies to Treat Type 2 Diabetes Mellitus [2011-04-27]
- Draft Guidance Document - Hepatotoxicity of Health Products [2011-02-16]
- Guidance Document: Schedule A and Section 3 to the Food and Drugs Act [2010-10-26]
- Draft Guidance Document - Labelling of Pharmaceutical Drugs for Human Use [2010-07-07]
- Release of the finalized Guidance Document: Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice [2010-04-30]
- Questions and Answers [2010-04-30]
- Guidance Document: Human-Use Antiseptic Drugs [2009-12-04]
- Guidance Document on Post-Drug Identification Number (DIN) Changes [2009-06-10]
- Review of Data Protection Inquiries Process [2010-07-27]
- Guidance Document: Acetaminophen Labelling Standard [2009-10-28]
- E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories [2008-07-29]
- Guidance Document: Submission of Pharmacogenomic Information [2008-05-23]
- Draft Guidance For Industry - Marketed Health Product Name Assessment: Look-alike Sound-alike (LA/SA) Health Product Names [2005-11-24]
- Guidance for Industry: Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names [2005-10-31]
- Good Manufacturing Practices
