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Regulatory Focus™ > News Articles > Health Canada Opens Consultation on Mandatory Adverse Drug Reaction, Device Incident Reports

Health Canada Opens Consultation on Mandatory Adverse Drug Reaction, Device Incident Reports

Posted 28 June 2017 | By Zachary Brennan 

Health Canada Opens Consultation on Mandatory Adverse Drug Reaction, Device Incident Reports

Health Canada on Tuesday opened up a consultation on changes to the country's Food and Drug Regulations and Medical Devices Regulations that would make it mandatory for certain health care institutions to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs).

"Reports about serious ADRs and MDIs can be important signals of emerging safety issues. Such post-market observations can also lead to improved safety information about a product," the regulator said.


The Protecting Canadians from Unsafe Drugs Act, also known as Vanessa's Law, makes several amendments to the Food and Drugs Act, including a new requirement for health care institutions to provide Health Canada with information on serious ADRs and MDIs. 

"Under-reporting has been a long-standing issue for Health Canada and therapeutic product regulators worldwide," Health Canada said. "Although Vanessa's Law received Royal Assent in November 2014, this requirement will come into effect when accompanying changes are made to both the Food and Drug Regulations and the Medical Devices Regulations."

In addition to the new reporting requirement, a separate regulatory amendment would allow the importation of drugs for immediate and urgent public health needs that have been already authorized for sale in the US, EU or Switzerland, but that are not yet available in Canada.

Health Canada said that relevant stakeholder feedback received on the regulatory amendment to import drugs for an urgent public health need will be used alongside input to the consultation on ADR and MDI reporting.


The consultation lays out a number of new ways that the new requirements would apply. Health Canada is proposing that the new regulatory requirements apply to all hospitals that provide acute care services, though it also offers the alternative of applying the new requirements to just a subset of acute care hospitals, such as teaching and large community hospitals, or long-term care facilities in addition to hospitals that provide acute care, or all health care institutions.

Health Canada is also proposing a timeline of 30 days for both serious ADR and MDI reporting, with the clock starting on the day that the serious ADR/MDI is first documented.

The proposal also defines both a minimum set of information data fields and a set of additional data fields to be "required to be completed, if the information is known" and provided to Health Canada.

The scope of therapeutic products to which these reporting requirements apply would include: Pharmaceuticals (prescription and non-prescription, but not natural health products), biologics (but not vaccines or blood products or cell or tissue products), radiopharmaceuticals, disinfectants and medical devices.

The online consultation period runs from 28 June 2017 to 11 August 2017. A webinar on the consultation paper will be hosted by Health Canada on 18 July.

Consultation Paper: Toward Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Health Care Institutions


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