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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.
- Consultation on the Plain Language Labelling Initiative [2013-06-24]
- Information for Industry on the proposed regulatory amendment for a Fact Table [2013-06-24]
- Information for Canadians about the Plain Language Labelling Initiative [2013-06-24]
- Information for Industry on the proposed regulatory amendments to submit mock-ups of labels [2013-06-24]
- Guidance Document: Determining Prescription Status for Human and Veterinary Drugs [2013-06-21]
- Prescription Drug List [2013-06-21]
- Questions and Answers - Prescription Drug List [2013-06-21]
- Consultation on the new Prescription Drug List [2012-12-24]
- Draft Guidance Document: Acetylsalicylic Acid Labelling Standard [2012-07-27]
- Guidance Document: Pre-market Evaluation of Hepatotoxicity in Health Products [2012-04-18]
- 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- Draft Guidance Document - Data Requirements for Safety and Effectiveness of Subsequent Market Entry Inhaled Corticosteroid Products for Use in the Treatment of Asthma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]
- 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- Draft Guidance Document - Labelling of Pharmaceutical Drugs for Human Use [2010-07-07]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]
- 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- Draft Guidance For Industry - Marketed Health Product Name Assessment: Look-alike Sound-alike (LA/SA) Health Product Names [2005-11-24]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
- Haemodialysis Solutions Monograph
