Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals

Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals is an open dataset from Health Canada with 8 files (HTML); catalogue record updated 2021-06-02. On CanQuery you can follow the original downloads. Files are available in English and French.

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