Description
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).
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Publication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) | HTML | Open resource | |
| Publication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) | HTML | Open resource |