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Health Canada publishes final guidance documents on quality requirements for regulatory filings

Authored byKatie Lee

On October 30, 2017, Health Canada published the final version of the following guidance documents and 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.