The International Law Office reported that on October 30 2017 Health Canada published the final version of the following guidance documents and templates:
- Guidance Document: 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;
- Guidance Document: Certified Product Information Document – Chemical Entities; and
- Certified Product Information Document – Chemical Entities (CPID-CE) Template
According to the announcement, the guidance documents implement new requirements for new drug submissions and abbreviated new drug submissions, including requirements for stability studies regarding:
- three batches of product for existing drugs;
- commercial scale batches; and
- pilot scale batches for certain products.
The changes will be implemented by way of a phased-in approach, with:
- the general quality guidance requirements being implemented on January 30 2018; and
- the new stability requirements and requirements for commercial and pilot scale batches being implemented on October 30 2019.
After October 30 2019, a submission must contain at least six months’ stability data on at least three primary batches of the drug substance and product.