On January 18, 2018, Health Canada and the Institute for Safe Medication Practices Canada (ISMP Canada) opened its consultation on different approaches to the naming of biologic drugs, including biosimilars (see our Update on Biosimilars). The objective of the consultation is to gain insight into stakeholder views on the practical impacts of different approaches to the naming of biologic drugs and biosimilars throughout the medication-use process, including prescribing, dispensing, and adverse drug reaction reporting. Stakeholder views on the aforementioned topics will inform Health Canada's ultimate policy decision on the naming convention for biologic drugs.
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
