Health Canada
www.hc-sc.gc.ca
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Institutional links
Drugs and Health Products
Chemical Entity Products/Quality
- Policies
- Quality Overall Summary - Chemical Entities (QOS-CE) Templates
- Good Manufacturing Practices
- Draft Guidance Document - Drug Master Files (DMFs) [2008-09-05]
- Guidance Document Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals [2008-04-21]
- Pharmaceutical Sciences - Questions and Answers [2007-05-23]
- Guidance for Industry: Pharmaceutical Quality of Inhalation and Nasal Products [2006-02-01]
- Draft Guidance for Industry - Impurities in Existing Drug Substances and Products [2005-09-06]
- Notice: Draft Guidance for Industry - Identification, Qualification, and Control of Related Impurities in New Drugs [2005-09-06]
- Guidance for Industry: Pharmaceutical Quality of Aqueous Solutions [2005-02-15]
- Draft Guidance for Industry: Quality Guidance: Applications for Drug Identification Numbers (DINAs) for Pharmaceuticals [2003-07-16]
- Stability Testing of Existing Drug Substances and Products [2003-06-10]
- Draft Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) [2001-07-18]
- Stereochemical Issues in Chiral Drug Development [2000-02-14]
- Reduction in the use of Dichloromethane in Tablet Coating Operations [1997-07-21]
