Pharmacovigilance is an essential pillar for ensuring patient safety and the correct use of medicines. The third revision of Module XVI of Good Pharmacovigilance Practices (GVP) came into force in August 2024, updating and strengthening the rules relating to risk minimization measures .
Among the most significant innovations is Addendum II , which introduces detailed guidance on how to assess the impact of adopted measures in a structured and effective manner. Pharmaceutical companies are now required to demonstrate not only the formal implementation of these measures, but also their actual effectiveness, through the collection and analysis of structured data and real-world evidence .
This means, for example, that companies will have to:
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actively monitor patient compliance with safety measures;
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use advanced analytical methods to assess the impact of educational materials and restrictions on use;
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integrate pharmacovigilance data with other real-world sources to obtain a comprehensive view of residual risks;
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constantly update its internal procedures to align with the requests of regulatory authorities.
The impact on companies is significant: the revision of GVP XVI requires a more dynamic and results-oriented approach, where simply implementing measures is no longer sufficient. It will be necessary to demonstrate, with concrete data, that the actions taken have effectively reduced risks to patients.
To best address this challenge, companies can adopt digital systems for data collection and analysis, train staff in advanced assessment methodologies, and implement continuous monitoring processes.
Discover our guides on Pharmacovigilance compliance for practical examples and operational guidance on how to adapt company procedures to the new GVPs.
