Patient safety measures continue to evolve globally, particularly with the increased number of emerging specialty medicines. Traditional initiatives focused on reactive response to recorded trends can no longer support the purpose of Pharmacovigilance. The PV landscape is shifting to predictive PV and proactive measures. What drives patient safety today in the era of increased use of technology and artificial intelligence requires foresight and thinking beyond retrospective benefit-risk assessment.
What additional measures did Health Canada introduce to protect Canadian patients beyond routine GVPs?
With the amendment of the Canadian Food and Drugs Act, Health Canada implemented a series of regulatory measures to ensure proactive patient safety monitoring and early product risk identification. Starting with enacting Vanessa’s Law directly contributing to added product safety-risk visibility mandating Canadian hospitals to report serious ADRs & MDIs related to Pharmaceuticals and Medical devices, all the way to the implementation of Notification of Foreign Actions regulation requiring Canadian MAHs to proactively identify and assess foreign risks that could impact Canadian patients.
Basic processes may support regulatory and GVP compliance in the short-term. Understating the purpose behind each regulation and building a cohesive structure, with a clear decision-tree and a well-tested communication plan is what makes those processes sustainable to serve the purpose.
International MAHs may have limited working knowledge of the intricacies of Health Canada GVP regulations. Often times Regulatory Intelligence describes the process of staying up-to-date with the evolving regulatory guidance of the different health authorities. Safety signal detection and emerging safety issue monitoring might be limited to routine ICSRs and safety relevant information.
Here are the key requirements that make NFA regulation unique in supporting patient safety:
- Comprehensive scope covering Safety/Toxicity, Label change and recall alerts
- Stringent reporting window of 72-hours from the time of identifying the alert
- Documented assessment and rationale by a qualified PV professionals
Understanding Notification of Foreign Actions’ requirement is crucial for compliance and successful GVP inspection outcome. NFA monitoring is becoming increasingly challenging for Canadian MAHs. With the higher number of products approved by Health Canada, and the global transparency initiatives making safety risks publicly accessible much faster than ever before. This makes readiness to scale while maintaining good documentation and evidence levels a must not an option.
What did we do to address this?
Zenith PV pioneered a one-of-a-kind AI-enabled Regulatory Intelligence & NFA monitoring tool compliant with Health Canada requirements for Pharmaceutical Drugs and Medical Devices. Canadian MAHs no longer need to perform manual searches or rely on external translation agencies. End-to end audit-trail tracking, signal trending, dashboards & analytics are at the core of Zenith Insights tool.
Here is why you should subscribe to Zenith Insights:
- Receive timely alerts and avoid time spent on manual searches
- Meet the 72-hour reporting timeline with faster assessment through AI-enabled recommendations and insights
- Track your notifications in an audit-ready platform supporting PSUR compilation
If you currently do not have a suitable compliant solution, or are unhappy with the output; Speak a Zenith expert today to book your demo of our Zenith Insights tool at info@zenithpv.ca
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