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What Improvements Are Recommended by the Report?
The report, which was issued on 15 October 2024, introduces several changes in the European Pharmacovigilance landscape which are aimed at enhancing the safety monitoring of both human and veterinary medicinal products within EU borders. Chief among these include stricter regulations and requirements under the newly revised framework, particularly for MAHs of centrally authorized products (CAPs). This follows the working group’s investigations that identified more than a dozen deficiencies and irregularities in its 2023 findings. To counter these gaps, the PhV IWG is pushing for more harmonization among EU member states to promote shared standards and consistency in pharmacovigilance inspections, reporting protocols, and data management. The joint efforts in 2023 have already proved fruitful, with jointly held inspections yielding greater alignment among members toward a common goal to ensure that all MAHs uphold the highest safety standards and improve the timeliness and accuracy of adverse event (AE) reporting across the European Union. As highlighted in the report, coordinated efforts in the inspection and monitoring of human and veterinary products will go a step further in ensuring cross-border, allowing for quicker identification and response to issues related to product safety in the region.
To promote transparency and allow for timely reporting and streamlined inspection management, the report advocates for the adoption of digital tools like IRIS platform to make pharmacovigilance coordination more efficient. This means MAHs of both human and veterinary medicinal products should now more than ever prioritize setting up and maintaining digital systems that facilitate real-time adverse event reporting, data integration, and compliance tracking.
Human Pharmacovigilance
As indicated earlier, several deficiencies were identified during the inspections, with the majority of the issues found in the QMS, PSMF, and the reporting of suspected AEs. Although these issues vary in severity, they can largely be attributed to core factors such as gaps in training, auditing, and data management processes. According to the report, addressing these issues will require a multifaceted approach from MAHs, including regular audits, targeted training for staff (particularly those in pharmacovigilance), enhancing the quality and timeliness of AE reporting, and ensuring the accurate use of EudraVigilance for capturing and analyzing safety data. Additionally, awareness of new and emerging technologies, including AI, may support ongoing improvements in pharmacovigilance processes.
Veterinary Pharmacovigilance
The working group also emphasizes stricter pharmacovigilance practices for veterinary medicine, particularly in the recording of inspection outcomes and the handling of suspected adverse events. Specifically, it highlights the implementation of new veterinary pharmacovigilance legislation, including detailed recording of inspection outcomes in the pharmacovigilance database and monitoring requirements under Regulation (EU) 2019/6. In the nine Veterinary inspections several deficiencies were identified, with the majority of the issues found in the QMS, PSMF), and the reporting of suspected AEs.
What’s Next for MAHs?
There is no doubt that the 12-page document provides invaluable insights into the current state of European pharmacovigilance at a critical time when digital advancements are gaining ground in almost every industry, including life sciences. The deficiencies highlighted by the 2023 report signal the challenges some pharmaceutical MAHs face in consistently maintaining updated pharmacovigilance practices. While ensuring full compliance with these standards can be complex, maintaining robust, well-audited systems is essential as regulatory scrutiny intensifies. At PQE Group, we know how overwhelming dealing with regulations and new pharmacovigilance guidelines can be, which is why we have made it our mission to support human and veterinary medical product MAHs—especially now, with increased regulatory expectations and the need to always be inspection-ready, as outlined in the report. From setting up and maintaining robust Quality Management Systems to Audit and Inspection Readiness and everything in between, trust our expertise and two and a half decades of experience to guide you through every step of compliance, ensuring your systems are not only compliant but also optimized for efficiency and safety.
