Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals
To assist submission sponsors in preparing Clinical Trial Applications (CTAs) filed with Health Canada by outlining the Quality (chemistry and manufacturing) technical requirements for CTAs pursuant to Division C.05 of the Food and Drug Regulations.
- Publisher
- Health Canada
- Resources
- 8
- Catalogue metadata updated
- 2021-06-02
Data overview
- Formats
- HTML
- File languages
- English, French
Official sources and licences
Resources
- Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals (French, HTML) HTML
- Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals (English, HTML) HTML
- Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase II (QOS-CE (CTA - Phase II) (French, HTML) HTML
- Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase II (QOS-CE (CTA - Phase II) (English, HTML) HTML
- Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase I (QOS-CE (CTA - Phase I) (French, HTML) HTML
- Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase I (QOS-CE (CTA - Phase I) (English, HTML) HTML
- Quality Overall Summary - Chemical Entities Clinical Trial Applications Phase III (QOS-CE (CTA - Phase III) (French, HTML) HTML
- Quality Overall Summary - Chemical Entities Clinical Trial Applications Phase III (QOS-CE (CTA - Phase III) (English, HTML) HTML