Food and Drugs Act amendments: Bill C-97, tabled in April, proposed amendments to the Food and Drugs Act, including a new framework for “Advanced Therapeutic Products”, a class of products that “represent an emerging or innovative technological, scientific or medical development”. The Bill received Royal Assent in June and will come into force on a day to be fixed.
Food and Drug Regulations amendments: March proposed amendments would (i) permit a generic drug having a different salt form of the Canadian reference product to be filed as an abbreviated new drug submission, (ii) revise labelling practices for the medicinal ingredient in drug products, and (iii) make related amendments to the definition of “innovative drug” in the data protection provision.
A pair of May proposed amendments would streamline the process for providing access to unauthorized drugs (i) for medical emergencies through the Special Access Program (for human drugs) / the Emergency Drug Release Program (for veterinary products), and (ii) to a public health official, consistent with other jurisdictions such as the U.S., the EU or Australia.
On March 4, the final regulations addressing the public release of clinical information came into force; Health Canada intends to proactively publish clinical information for submissions that receive a final regulatory decision after this date (see our live chart, tracking the progress of Vanessa’s Law regulatory amendments and associated guidance).
Medical devices: Following the release of its December 2018 action plan, Health Canada commenced a number of initiatives including: as of January 31, publishing Regulatory Decision Summaries for Class III medical device licences; launching an e-Learning Tool for understanding premarket regulation; and proposing amendments to the Food and Drug Regulations and the Medical Devices Regulations in accordance with Vanessa’s Law.
Court decisions: The Federal Court of Appeal (FCA) affirmed the dismissal of Apotex’s challenge of Health Canada’s rejection of its abbreviated new drug submission for Apo-Omeprazole (omeprazole magnesium) tablets. The Supreme Court of Canada (SCC) declined to grant Apotex leave to appeal regarding Health Canada’s decision requiring Apotex to submit additional information for products manufactured or tested in Apotex’s facilities in India.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.