Policies

Policy documents are interpretations of the purpose and intent of the Food and Drugs Act and Regulations.

• Notice: Application of the definition of Canadian Reference Product [2024-01-26]
• Policy statement: Use of pharmacometrics in drug submissions and clinical trial applications [2021-03-31]
• Notice: Guidance on the Use of a Foreign-sourced Reference Product as a Canadian Reference Product [2017-11-27]
• Notice: Limiting the Strength of Acetaminophen to 325 mg per Dosage Unit in Prescription Combination Products [2016-09-15]
• Proposed Policy on Bioequivalence Standards for Highly Variable Drug Products [2015-06-26]
• Updated Notice: Interim Policy on Health Canada's Interpretation of Medicinal Ingredient and Assessment of Identical Medicinal Ingredient [2017-10-05]
• Drug/Medical Device Combination Products Policy [2005-11-30]
• Priority Review of Drug Submissions Policy [2007-12-20]
• Assignment of Drug Identification Numbers for Drug Products in Kits [1997-07-21]
• Bioequivalence of Proportional Formulations: Solid Oral Dosage [1996-03-07]
• Filing of SNDSs, SANDS, NCs and X-REFs [1996-05-10]
• Herbs used as Non-medicinal Ingredients in Nonprescription Drugs for Human Use [1995-09-22]
• Inclusion of Women in Clinical Trials during Drug Development [1996-09-25]
• Interpretation of "Identical Medicinal Ingredient" [2003-07-09]
• Issue Analysis Summary: Regulatory strategy for pharmaceutical products with photo co-carcinogenic potential [1999-04-15]
• Labelling of Professional Samples of Drugs [1994-02-11]
• Labelling of Special Containers [1990-04-04]
• Policy on Drug/Medical Device Combination Products - Decisions [2014-07-22]
• Policy: Submissions for Generic Topical Drugs [1990-09-24]
• Submissions for Generic Parenteral Drugs [1990-03-01]
• Submissions for Topical Non-Steroidal Anti-inflammatory Drugs (Topical NSAIDs) [1998-07-22]