Foreign action notification to Health Canada
By Innomar Strategies
Understanding Health Canada’s unique foreign action reporting requirement
For several years, Health Canada has required marketing authorization holders (MAHs) to provide notification of foreign regulatory actions regarding its drug products. Now, the guidance is undergoing consultation and revision with the aim of clarifying issues and addressing gapsi.
The objective of foreign action reporting, however, remains the same: To enable Health Canada to identify any risks to patients in Canada during a product’s life cycle and to act where risks are identified.
What is foreign action reporting?
While pharma manufacturers need to be generally aware of foreign action reporting around the world and to record reported safety events, Health Canada places the onus on the MAH, who may or may not be the pharma manufacturer, in including this requirement in Health Canada inspection guidelines.
The requirement on foreign action reporting was enacted by Health Canada following concerns that MAHs were not reporting adverse events in a timely manner. While foreign action reporting has been in place since 2018 when the initial guideline was published in Canada Gazette Part IIii, Health Canada inspectors are now asking MAHs to show proof of their foreign risk monitoring processes.
Examples of foreign risks that must be reported to Health Canada under current guidelines include (i) serious risks related to new contraindications or warnings, (ii) recalls due to a serious risk, (iii) manufacturing issues that pose a serious risk to human health, and (iv) labeling changes. All these examples apply only when they are publicly communicated to foreign regulatory authoritiesiii.
Over time, gaps and lack of clarity about these reporting requirements have become apparent. Health Canada is seeking to update the guidance and initiated a 60-day consultation period on the revisions from September 25 until November 24, 2025. The agency has said all feedback will be considered before a final version of the guidance is publishediv.
What might the new guidance look like?
The updated draft guidance has now been published by Health Canada and reiterates that reporting only applies to publicly disclosed foreign actions. In other words, if the local MAH is having confidential discussions with a foreign regulator or has actual non-public knowledge of pending action with the foreign regulator, that is not required to be disclosed to Health Canada until it is publicly disclosed (i.e., as relevant to influence a label change or safety notice in Canada).
The updated draft guidance also reiterates (a) that manufacturing sites must be included, (b) that class effect warnings and the drug sold in Canada containing ingredients in that class must be considered, (c) that veterinary products are included, and (d) that there must be an appropriate medical impact assessment and Canadian action statement.
Health Canada has also made clear in the updated draft guidance that (1) only the first regulatory notification must be sent, and that (2) duplications should be removed. However, if the action differs in severity across regulators — for example, a recall in one country versus a label change in another — this difference must be noted.
Once finalized, the new guidance is expected to give Health Canada auditors a clearer way to review possible deficiencies in foreign action reporting by the MAH.
What should MAHs be doing to meet their obligations?
The anticipated Health Canada “new requirement” will be for companies to have a detection and reporting system in place to become aware of any actions taken by foreign health authorities involving their product and at the manufacturing sites where their products are made and report them to Health Canada where appropriate. This includes activities that may not directly involve their product, but which could have implications for the safety of their products (e.g., such as mould at a manufacturing site where their product is made or other government inspection relevant findings.)
Canadian MAHs will be expected to report foreign actions to Health Canada within 72 hours of becoming aware of them.
Another challenge for MAHs is the fact that foreign action review and reporting can be very labor-intensive and prone to error if it is not rigorously managed and maintained. The sheer number of sites that need to be reviewed can be overwhelming, with more than 100 government websites from different regulatory authorities needing to be scanned to determine which is relevant to a globally commercialized product.
There is also a great deal of duplication to sift through if the same notification is posted by multiple health authorities. Some notifications may apply to a generic product, but if that does not apply to the MAH’s brand reference product in Canada this information need not be reported. At the same time, if the report applies to an active pharmaceutical ingredient (API) that is relevant to an MAH’s brand reference product, it could be relevant, and an assessment on reporting requirements will need to be made.
Staying on top of these foreign actions can be very challenging for MAHs if they rely on local foreign affiliates to keep them informed. Health Canada will expect that companies have a systematic way of ensuring that they are aware of foreign notifications. Health Canada will require only actions that have been publicly disclosed to be reported, as reporting on unconfirmed speculation or confidential discussions can be an unreasonable or unhelpful burden for MAHs and regulators.
Meeting Health Canada’s expectations
While it will be some time before the draft guidance is finalized and published, MAHs must still ensure that they are meeting current requirements. It is unlikely that the updated guidance will mitigate the challenges companies face in foreign action reporting since they will likely only enhance the scale involved and the manual nature of scanning foreign regulatory websites. It will, however, provide auditors with something more tangible to audit, which in turn will require greater accountability and clarity by MAHs.
Ultimately, foreign action reporting is a pharmacovigilance requirement, and MAHs do need to meet their obligations. Health Canada inspections help MAHs identify any process issues and MAHs will need to implement a plan to address any process deficiencies. Those who fail to comply, however, might face more serious sanctions, including, as a last resort, having their drug removed from the market.
About the author
Larry Hough, Senior Director, Pharmacovigilance and Medical Information, at Innomar. He has more than 30 years of leadership experience in pharmacovigilance and medical information across the pharmaceutical industry and has been with Innomar for four years.
Did you know that Innomar can submit foreign action safety reports on your behalf using eCTD? Contact us today to learn more.
i Draft guidance on notifying Health Canada of foreign actions, Health Canada. Guidance on notifying Health Canada of foreign actions - Canada.ca https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/notifying-foreign-action.html
ii Canada Gazette Part II, May 2018. Canada Gazette, Part II https://gazette.gc.ca/rp-pr/p2/2018/2018-05-02/pdf/g2-15209.pdf
iii Notifying Health Canada of Foreign Actions - Guidance Document for Industry, Government of Canada. Notifying Health Canada of Foreign Actions - Guidance Document for Industry - Canada.ca https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/foreign-actions-profile/guidance-document.html#2.1
iv Consultation for guidance on notifying Health Canada of foreign actions, Health Canada. https://www.canada.ca/en/health-canada/programs/consultation-draft-guidance-notifying-foreign-actions.html
