Advanced therapeutic products have been the topic of much debate recently. First, on 21 June 2019 Bill C-97 received royal assent. Bill C-97 includes amendments to the Food and Drugs Act, including a new framework for advanced therapeutic products and will come into force on a day to be fixed. Second, on 18 July 2019 Health Canada opened a consultation to seek feedback on what it should consider when developing new clinical trial regulations as well as implementing the pathway for advanced therapeutic products. The consultation will close on 30 August 2019.
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