The ongoing initiative to modernize the Food and Drugs Act and subsidiary regulations is intended to provide Health Canada the necessary authorities and tools to effectively regulate health products throughout their lifecycles. The vigilance of health products is a key element of a life-cycle approach, and work is currently underway to adopt modern methods of vigilance for health products in Canada. The goal is to ensure that regulatory oversight and requirements are proportional to actual or perceived risk, that tools and requirements "work together" in a cohesive fashion and that regulatory approaches are, whenever possible, aligned with those of comparable international regulatory counterparts. This will also involve the full integration of International Conference on Harmonisation (ICH) vigilance tools within a vigilance "framework" defined by an inter-related set of regulations, polices, guidances and procedures.
Stakeholders will be consulted on the development of a vigilance framework as part of broader consultations on the modernization of the Food and Drugs Act and Regulations. Towards this end, a consultation document is under development that will describe how vigilance activities are currently conducted at Health Canada; what a new vigilance framework should look like and how individual vigilance tools such as periodic safety update reports (PSURs), pharmacovigilance plans (PvPs), risk management plans (RMPs) and others should be applied and operate within the framework; and the set of principles guiding development work.
In recognition of the fact that the tools mentioned above are already in international use, there is also a need to clarify Health Canada's current expectations regarding the use of certain vigilance tools prior to the implementation of a new vigilance framework. This will be accomplished through a series of notices that will be posted to this Web page.
- Guidance Document - Periodic Benefit-Risk Evaluation Report (PBRER) International Conference on Harmonisation (ICH) Topic E2C(R2)
- Notice - Adoption of the International Conference on Harmonisation (ICH) Guidance on Periodic Benefit Risk Evaluation Report - ICH Topic E2C(R2), as of March 1, 2013
- Health Product Vigilance Framework
- Notice of Implementation of a Risk-Prioritized Periodic Safety Update Report Regulatory Review Pilot at Health Canada, including the adoption of the International Conference on Harmonisation (ICH) Guidance Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs - ICH Topic E2C, as of April 1, 2010.
- Notice - Regarding Implementation of Risk Management Planning including the adoption of ICH Guidance Pharmacovigilance Planning - ICH Topic E2E
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