Pharmacovigilance and quality management are closely connected. Both aim to ensure that medicines remain safe and effective throughout their entire lifecycle. In 2025, the pharmacovigilance landscape is undergoing significant change as the new Implementing Regulation (EU) 2025/1466 introduces updated requirements for audits, subcontracting and data protection.
The quality of a pharmacovigilance system is not accidental
According to Medimo’s founder Anu Gummerus, a high-quality pharmacovigilance system is built through systematic work and continuous improvement. It relies on competent personnel, well-defined processes and a risk-based audit strategy that together ensure the reliability and effectiveness of the system.
In line with Good Pharmacovigilance Practices (GVP), companies must have sufficient trained staff, up-to-date procedures and functional IT systems that support the monitoring and reporting of safety data. Managing deviations and corrective and preventive actions (CAPA) is also a key part of maintaining quality.
New regulation clarifies responsibilities and strengthens oversight
The Implementing Regulation (EU) 2025/1466, which will apply from February 2026, introduces more detailed requirements for marketing authorisation holders. These include clearer definitions of responsibilities, updated contractual requirements and wider audit coverage.
All outsourced pharmacovigilance activities must now be fully auditable, including those carried out outside the EU. Contracts must also clearly define roles, responsibilities and access rights for audits and inspections.
The content of the Pharmacovigilance System Master File (PSMF) will also be refined. In the future, only major and critical deviations must be listed in the PSMF, and the way audit findings are documented will be aligned more closely with GVP Module II.
Digitalisation and artificial intelligence support pharmacovigilance
Artificial intelligence and automation are becoming part of everyday pharmacovigilance work. These technologies can help identify safety signals more quickly and improve the timeliness of safety information. International guidance, such as the EU AI Act, FDA recommendations and CIOMS Working Group XIV proposals, are shaping the safe and responsible use of AI in this field.
Authorities emphasise that while technology can enhance efficiency, human oversight, secure data management and strong cybersecurity remain essential.
Fimea’s new guidance promotes clarity and safety
National developments are also advancing. Fimea recommends the introduction of a new safety information symbol for risk minimisation materials and safety communications intended for healthcare professionals. The goal is to make these materials easier to identify and to support the effective delivery of important safety information.
Lääketurva 2025 brought key topics together
These themes were widely discussed at the Lääketurva 2025 event, where experts examined the impact of the new regulatory requirements, the role of data in decision-making and the future of pharmacovigilance.
In her presentation, Anu Gummerus highlighted practical aspects of maintaining and continuously improving quality management systems. Elements that are essential for compliant and sustainable pharmacovigilance operations.
