On October 30, 2017, Health Canada published the final version of the following guidance documents and template:
- 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
- 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 on three batches of product for existing drugs, commercial scale batches and pilot batch sizes for certain products. The changes will be implemented in 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 scale and pilot scale batches becoming fully implemented on October 30, 2019. After October 30, 2019, a submission must contain at least 6 months of stability data on at least 3 primary batches of the drug substance and drug product.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.