On July 12, 2018, Health Canada had published “Guidance on Notifying Health Canada of Foreign Actions – Guidance Document for Industry”. On November 20, 2018, Health Canada updated its Guidance, including with a link to an on-line reporting form: Notifying Health Canada of Foreign Actions - Guidance Document for Industry, updated November 20, 2018. This update comes after the foreign risk reporting requirement provisions of the Food and Drug Regulations (as previously reported) came into force in October 2018. We have updated our previously published chart to include this Guidance.
Related Publications & Articles
-
Medical Devices updates: Phase II consultation on Medical Devices Regulations amendments, medical device licences guidance and IMDRF table of contents guidance
On November 17, 2025, Health Canada proposed Phase II amendments to the Medical Devices Regulations (MDR). The first phase of amendments came into force on December 14, 2024 and relate to recalls, mod...Read More -
Proposal for modernizing clinical trial framework aims to improve access to new and innovative therapies in Canada
On December 20, 2025, Health Canada launched a consultation on modernizing the framework for clinical trials involving drugs for human use, including pharmaceuticals, biologics, radiopharmaceuticals, ...Read More -
Health Canada consultation on two draft guidance documents on terms and conditions for human and veterinary drugs and drug submissions based on promising evidence of clinical efficacy
As previously reported, in December 2024, Health Canada published its agile licensing amendments to the Food and Drug Regulations.Read More
