Consultation: mandatory reporting of serious adverse drug reactions and medical device incidents

Current status:  Open

You’re invited to comment on proposed changes to the Food and Drug Regulations and Medical Devices Regulations. These changes would make it mandatory for health care institutions to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs).

Why

We want to make sure that serious ADRs and MDIs are reported to Health Canada so that there is enough information to detect safety problems.

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.

Improving our knowledge about product safety will help Canadians and their health care providers to make better, more informed decisions about their medical treatment and support overall patient safety.

Who

Before pre-publication of the proposed changes in Part I of the Canada Gazette, we are asking for feedback from all interested Canadians, including:

  • health care institutions
  • health care professionals
  • provinces and territories
  • patient advocacy groups
  • biomedical engineers
  • any interested members of the public
  • other interested people or organizations
  • members of the pharmaceutical and medical devices industry

What

Health Canada is looking for comments on the regulatory proposals found in:

The changes being suggested would put in place a new reporting requirement for health care institutions.  We are seeking advice and input from participants in 5 areas:

  • which kinds of health care institutions should report
  • what types of serious adverse drug reactions and medical device incidents should be reported
  • which health products should be reported on
  • what information should be included in the report
  • what timelines for reporting should be in place

We are also seeking feedback on suggested non-regulatory approaches to improve serious ADR and MDI reporting in an institutional setting, including:

  • outreach and education
  • giving meaningful feedback back to reporting institutions

When and Where

The online consultation period runs from June 28, 2017 to August 11, 2017.

An Information Webinar on the consultation paper will be hosted by Health Canada on July 18. 

How to Participate

You are encouraged to read the consultation paper for more information.
You may submit your comments and ideas by:

If you are interested in attending the Information Webinar, please send us your name and email address no later than Wednesday, July 12th.

You may also contact us for additional information about the Information Webinar or to comment or ask questions about this initiative.

Next Steps

Feedback received on or before August 11, 2017 will be considered in our regulatory proposal on mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions.

A summary of comments will be published in the Regulatory Impact Analysis Statement at Canada Gazette, Part 1.Footnote 1

Related Information

Contact us

Policy and International Affairs Section
Therapeutic Effectiveness and Policy Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Address Locator 1912C
Ottawa, Ontario
K1A 0K9
Email: MHPD-DPSC.VL-LV@hc-sc.gc.ca

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