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03 January 2018
On October 30 2017 Health Canada published the final version of the following guidance documents and templates:
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:
The changes will be implemented by way of a phased-in approach, with:
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.
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