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Bill C-97: Proposed amendments to the Food and Drugs Act would establish framework for “Advanced Therapeutic Products”

Bill C-97, An Act to implement certain provisions of the budget tabled in Parliament on March 19, 2019 and other measures was introduced in the House of Commons on April 8, 2019, and includes proposed amendments to the Food and Drugs Act to introduce a new framework for “Advanced Therapeutic Products”, including a new licensing framework.

The proposed amendments define an “Advanced Therapeutic Product” as a product or class of products set out in Schedule G. Thus far, Schedule G does not contain any entries, but the proposed amendments allow the Minister to make additions to Schedule G if the Minister believes the product or class of products “represent an emerging or innovative technological, scientific or medical development”.

It is unclear what the full details and scope of this framework will encompass, however it is expected that advanced therapeutic products may include regulation of newer technologies such as cell and gene therapies, 3D printing and novel drug delivery methods. The proposed amendments align with the What we heard:  A summary of scanning and consultations on what’s next for health product regulation report issued by Health Canada in March 2019. The report identifies various emerging technologies that Health Canada will be considering further and which Health Canada recognizes are challenging current regulatory classification schemes.