Health Canada has published updated guidance documents for marketing authorisation of new drugs
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
