Notice for Industry: Mandatory Reporting Requirement during the COVID-19 Pandemic
COVID-19 is a rapidly evolving global issue. The Government of Canada will do everything necessary to protect the health, safety, and wellbeing of Canadians, and is working around the clock to limit the spread of this pandemic. Our top priority remains the safety and security of all Canadians.
Health Canada has been working closely with the Public Health Agency of Canada, which is leading the public health response and pandemic planning, as well as with provincial, territorial and international partners to respond to this evolving situation.
In light of the COVID-19 outbreak, Health Canada is clarifying expectations for manufacturers, importers and market authorization holders (MAHs) regarding requirement to report adverse reactions (ARs) and medical device problems (MDPs) during a pandemic.
Health Canada's Canada Vigilance Program collects and assesses reports of adverse reactions (ARs) to health products and medical device problems (MDPs). Manufacturers, importers and MAHs are required to report ARs and MDPs that come to their attention. During the COVID-19 pandemic, the Department will continue to use the existing Canada Vigilance as well as medical device incident databases to monitor and analyze adverse events to health products. Subsets of these databases are available online for ARs and MDIs.
Although every AR and MDP report is important, reporting ARs and MDPs within the regulatory timeframes may not be feasible due to the impact of the COVID-19 pandemic on normal business operations and personnel.
Regulatory reporting of ARs and MDPs should be maintained to the maximum extent possible. However, due to pandemic-related employee and personnel shortages, Health Canada accepts if the submission of AR and MDP reports to Health Canada does not occur within the time frames stipulated under various applicable regulations, provided that any delayed submissions are sent as soon as feasible. MAHs, manufacturers and importers should maintain records to identify what has been delayed.
Reporting expectations and timelines will be maintained for some high priority products or those that may be used in a pandemic. These include antivirals, vaccines, medicines for outbreak symptom management, medical devices for the diagnosis and management of patients with COVID-19, blood and blood components, cells, tissues and organs (CTOs) and drug identification number-assigned (DIN) manufactured blood products. Furthermore, all reports of ARs and MDPs with death as an outcome should also be treated as priority, regardless of the suspect product.
All AR reports associated with confirmed or suspected cases of COVID-19 and that meet the requirements for expedited reporting should be identified as priority and submitted to Health Canada, in accordance with the Food and Drug Regulations, Natural Health Products Regulations, the Blood Regulations and the Cells, Tissues and Organs Regulations. Medical device incidents associated with COVID-19 should be reported in accordance with Health Canada's Interim order respecting the importation and sale of medical devices for use in relation to COVID-19.
With respect to reporting methods, Health Canada is aware that manufacturers, importers and MAHs' ability to fax or mail reports may be affected by the current pandemic. In order to provide reporters with some flexibility surrounding the submission of AR and MDP reports, MAHs who are not currently enrolled as trading partners with Health Canada may submit reports using the online reporting application available on Health Canada's website. Key data elements and pieces of information captured in the Mandatory Adverse Reaction Form for Industry or Council for International Organizations of Medical Sciences (CIOMS) form should be incorporated into the online submission under the most appropriate fields. This is only an interim solution and usual reporting processes should be restored as soon as feasible. MDPs (Medical Device Problem Reporting Form for Industry) may continue to be submitted via email to email@example.com.
Furthermore, we are encouraging reporters to use mechanisms other than hard-copy mail for the submission of AR and MDP reports to the Canada Vigilance Program.
Manufacturers, importers and MAHs as defined in the applicable Regulations should develop a business continuity plan (BCP) that outlines and justifies actions taken relating to AR or MDP reporting that differ from the requirements of the Regulations. As the pandemic progresses, the BCP should be maintained and updated as necessary.
As of May 4, 2020, Health Canada will be implementing MedDRA version 23.0 incorporating new COVID-19 terms. As per section 3.5 of the document "Reporting adverse reactions to marketed health products - Guidance document for industry", trading partners who are submitting Individual Case Study Reports (ICSRs) electronically to Health Canada will also be required to use MedDRA version 23.0. Any questions regarding MedDRA can be forwarded to the Canada Vigilance Program.
Please do not hesitate to contact the Canada Vigilance Program if you require further information.
Canada Vigilance Program
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