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.
Related Publications & Articles
-
Federal Court of Appeal dismisses appeal of SPRAVATO “innovative drug” decision
On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data...Read More -
CIPO will not issue patents on July 9 or July 16
The Canadian Intellectual Property Office (CIPO) will be launching a new online portal for patent services, MyCIPO Patents, on July 15, 2024.Read More -
2024 mid-year highlights in Canadian life sciences IP and regulatory law
In the first half of 2024, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories ...Read More