Health Canada proposes new regulations linked to Vanessa’s Law to further strengthen the safety and surveillance of drugs and medical devices
The proposed regulations will improve the reporting of serious adverse drug reactions and medical device incidents by hospitals
June 15, 2018 - Ottawa, ON - Health Canada
Adverse reactions to drugs and incidents involving medical devices account for many hospital admissions and emergency room visits in Canada every year. These serious adverse drug reactions and medical device incidents are significantly underreported by clinicians, which is a long-standing problem both in Canada and internationally.
Today, Health Canada published proposed regulations in Canada Gazette, Part I to amend the Food and Drug Regulations and Medical Devices Regulations to require hospitals to report serious adverse drug reactions and medical device incidents. This regulatory proposal supports authorities gained through the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law).
Under the proposed regulations, hospitals will be required to report to Health Canada all serious adverse drug reactions and medical device incidents, in writing, within 30 days of when the incident was first documented within the hospital. The proposed regulations aim to improve the quality and increase the quantity of serious adverse drug reaction and medical device incident reports provided to Health Canada.
Such reports are important in managing the risks associated with the use of drugs and medical devices, and are often the first sign of emerging safety problems. This new reporting requirement will help Health Canada better understand the benefits and harms of marketed health products, which will contribute to improving the safety of drugs and medical devices used by Canadians.
These new measures are part of the Government of Canada’s efforts to gather important safety information and to take necessary action, while minimizing impacts on hospitals and on the health care system.
The proposed regulations are based on the feedback that Health Canada received during its consultations to date. Canadians and stakeholders are invited to provide comments on the regulatory proposal between June 16 and August 29, 2018.
“Our Government is continuously looking for ways to strengthen product safety to help ensure better health outcomes for Canadians. Improved reporting will allow Health Canada to take action much more quickly against products that may pose a risk to the health and safety of Canadians.”
The Honourable Ginette Petitpas Taylor
Minister of Health
The reporting of adverse events provides direct information about the real-world experiences of patients and health care professionals using these products. These reports are important source of post-market drug and device safety information for regulators worldwide.
Health Canada has been consulting with the provinces and territories, as well as other stakeholders, on this new reporting requirement over the last two years. Publishing this regulatory proposal provides Canadians and stakeholders with an additional opportunity to help inform the design of the regulations.
- Consultation: mandatory reporting of serious adverse drug reactions and medical device incidents
- What we heard – Responses to the public consultation paper entitled Toward mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions
- Regulatory Initiative: Regulations amending the Food and Drug Regulations and Medical Device Regulations (Vanessa’s Law
- Protecting Canadians from Unsafe Drugs Act (Vanessa's Law): Questions/Answers
Office of Ginette Petitpas Taylor
Minister of Health
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