On January 30, 2018, the Government of Canada posted the Comprehensive and Progressive Partnership for Trans-Pacific Partnership (CPTPP) - Backgrounder. According to the Backgrounder, Canada and other signatories agreed to suspend certain obligations under the Trans-Pacific Partnership (TPP) with respect to intellectual property, patents and pharmaceuticals, including on patent term adjustments to compensate for unreasonable patent office delays and marketing authorization delays. Canada already provides for patent term extension for marketing authorization delays under the Patent Act and Certificate of Supplementary Protection Regulations which came into force September 21, 2017 (as previously reported). On February 20, 2018, Global Affairs Canada subsequently issued a news release announcing the release of the full text of the CPTPP and projected economic impacts of the CPTPP on Canada.
Related Publications & Articles
-
Medical devices updates: mandatory use of the regulatory enrolment process for medical devices and updated guidance documents related to the regulatory enrolment process
Health Canada released a notice to industry on April 24, 2026, outlining that manufacturers must use the Regulatory Enrolment Process (REP) and Common Electronic Submission Gateway (CESG) for medical ...Read More -
Health Canada seeks feedback on phased implementation of the incorporated by reference list for Ministerial Reliance Order
As previously reported, Health Canada has proposed a Ministerial Reliance Order that would allow Health Canada to rely on decisions of foreign regulatory authorities (FRAs). Health Canada has proposed...Read More -
Health Canada finalizes biosimilar guidance: comparative clinical efficacy studies not typically required
In Canada, biosimilar products are approved by way of a new drug submission, following Health Canada guidance first released in 2010 and significantly revised in 2016.Read More
