Changes to guidance on submitting risk management plans: Notice to stakeholders

Overview of changes

As part of the consultation on the proposed agile regulations, Health Canada is making changes to the Submission of risk management plans and follow-up commitments guidance document. This guidance was last updated on June 26, 2015.

The changes, including renaming the guidance, will reflect the proposed risk management plan (RMP) requirements in the Food and Drug Regulations as part of the agile licensing framework.

Other changes include:

• incorporating specific guidance for opioid products
• adding a Canadian-specific addendum template
• adding an RMP summary template
• incorporating the 2 notices published in 2020:
  • Notice of clarification to drug manufacturers and sponsors - Risk management plans - Update (August 13, 2020)
  • Notice of clarification to drug manufacturers and sponsors: Canadian-specific considerations in risk management plans (November 12, 2020)
• editing for plain language

After the agile licensing regulations come into force, we will discontinue the following guidance document and the previous notices:

• Submission of targeted risk management plans and follow-up commitments for prescription opioid-containing products

Transition to the Food and Drug Regulations

Those RMPs that Health Canada reviewed and accepted before the RMP provisions came into force in the Food and Drug Regulations will be subject to the regulations. These include the requirement to provide updates when risks and uncertainties associated with the drug are significantly different than those described in the existing plan.

We will communicate additional information on implementation if needed, once the final agile regulations are published in Canada Gazette, Part II.

This revised guidance document provides information that is relevant for:

• RMPs submitted after the revised Food and Drug Regulations come into force
• RMPs that were accepted before the revised Food and Drug Regulations come into force