Description
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.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals | HTML | Open resource | |
| Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase I (QOS-CE (CTA - Phase I) | HTML | Open resource | |
| Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase II (QOS-CE (CTA - Phase II) | HTML | Open resource | |
| Quality Overall Summary - Chemical Entities Clinical Trial Applications Phase III (QOS-CE (CTA - Phase III) | HTML | Open resource | |
| Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals | HTML | Open resource | |
| Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase I (QOS-CE (CTA - Phase I) | HTML | Open resource | |
| Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase II (QOS-CE (CTA - Phase II) | HTML | Open resource | |
| Quality Overall Summary - Chemical Entities Clinical Trial Applications Phase III (QOS-CE (CTA - Phase III) | HTML | Open resource |