Health Canada published final versions of guidance intended for industry and staff regarding the submission of information for marketing authorisation of new drugs.
A final version of the following Guidance Documents and templates are now available:
- Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
- ADDENDUM – Quality (Chemistry and Manufacturing) Guidance: Questions and Answers
- Glossary of Quality Terms
- Certified Product Information Document Guidance Document
- Certified Product Information Document-Chemical Entities (CPID-CE) Template