September 23, 2017
The Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) makes several amendments to the Food and Drugs Act (F&DA), including a new requirement for certain health care institutions to provide Health Canada with information on serious adverse drug reactions (serious ADRs) and medical device incidents (MDIs). The central objective of this authority is to improve the quality and increase the quantity of ADR and MDI reports, thereby ensuring that there is sufficient data to detect safety problems.
This consultation paper follows Health Canada’s engagement activities and responds to comments received from the provinces and territories and stakeholders since 2015. Health Canada is seeking advice and input from stakeholders on the regulatory proposals in the following five areas:
- Applicable health care institutions,
- Types of reportable serious adverse drug reactions and medical device incidents,
- Applicable therapeutic products,
- Applicable data fields, and
- Timelines for reporting.
Health Canada’s approach to improving the reporting of serious ADR/MDIs will be multi-pronged in nature and include non-regulatory approaches such as outreach and education as well as meaningful feedback to reporting institutions. Health Canada is also seeking feedback from stakeholders on the proposed non-regulatory approaches in the following areas:
- outreach and education, and
- providing meaningful feedback to reporting institutions.
Please note this consultation is now closed.