On June 21, 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. On July 18, 2019, Health
Canada opened a
consultation seeking feedback on what Health Canada should consider in developing new clinical trial regulations, as well as implementing the pathway for Advanced Therapeutic Products. The consultation will close on
August 30, 2019.