Health Canada published final guidance documents

The International Law Office reported that 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:

  • 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.

Please see the original article from ILO here.

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Published 8. January 2018 in News Canada