Publication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
Publication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) is an open dataset from Health Canada with 2 files (HTML); catalogue record updated 2023-09-03. On CanQuery you can follow the original downloads. Files are available in English and French.
Significant new requirements are presented in the guidance document (i.e. stability studies on three batches of product for existing drugs, commercial scale batches and pilot batch sizes for certain products).
- Publisher
- Health Canada
- Resources
- 2
- Catalogue metadata updated
- 2023-09-03
Data overview
- Formats
- HTML
- File languages
- English, French
Official sources and licences
Resources
- Publication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) (English, HTML) HTML · Download HTML
- Publication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) (French, HTML) HTML · Download HTML