Risk Management Plans (RMPs) are a key part of Health Canada’s approach to ensure drug safety throughout the drug life-cycle. RMPs help identify and assess new safety risks, define how those risks will be monitored and outline measures to minimize them, when uncertainties exist.

With Health Canada’s updated guidance made effective on July 1, 2025, Canadian Market Authorization Holders (MAHs) must ensure RMP strategies are up to date, and are aligned with the new Canadian requirements – not only during NDS/SNDS submission, but throughout the product lifecycle.

Why RMPs matter?

RMPs are designed to:

• Identify important known risks, potential risks, and areas of uncertainty around the product safety in the intended population
• Describe planned pharmacovigilance activities to further assess these risks
• Describe risk-minimization measures, and their effectiveness

Not all products require an RMP. An RMP is required when there is a significant degree of uncertainty about the risks associated with the drug, and when the drug presents a serious risk of injury to human health that warrants measures to reduce the likelihood of an injury.

When Are RMP Updates Required?

Health Canada does not expect routine or scheduled RMP updates. Instead, updates are required when meaningful changes occur, such as:

• New safety information that changes the benefit-risk profile
• Reassessment of known or potential risks
• Changes to pharmacovigilance activities
• Addition, removal, or modification of risk-minimization measures
• Expansion to new populations or indications

Common Challenges with Canadian RMPs

While the context of the RMP deficiencies is specific to the particular RMP in question and the MAH operational model. We highlight here a few of the most frequent definiens cited by Health Canada regarding RMP practices:

• Lack of adherence to post-approval surveillance commitments
• Failure to address the Canadian context
• Risk-minimization measures with no clear effectiveness evaluation
• Misalignment between the RMP, Canadian Product Monograph, and existing Safety Data

Proactively addressing these elements can help reduce follow-up requests, review delays and submission rejection.

Best Practices for RMP Lifecycle Management

To maintain compliance and support efficient regulatory interactions, MAHs should:

• Treat the RMP as a living document, not a one-time submission
• Align with the initiatives with the cross-functional teams
• Continuously monitor safety data to assess whether updates are necessary
• Maintain clear documentation of the rationale for each decision pertaining to the RMP

A structured and proactive approach helps ensure that RMPs remain compliant with Health Canada expectations through the product lifecycle.

Zenith PV experts can support you develop/update your RMP in full compliance with local regulatory requirements to meet Health Canada expectations and ensure your continued operational success to fulfill all PV commitments.