The pharmacovigilance (PV) landscape is evolving rapidly, triggered by increasing data volumes, global collaborative efforts, and demanding data transparency expectations. Given the scenario, 2026 is expected to become a defining year for the Pharmaceutical industry and its approach to pharmacovigilance. Frameworks like PV Regulatory guidance 2025, the updated EU Regulation 2025/1466, and ICH E2D(R2) are expected to enter their complete implementation cycles, making the upcoming year more structural than procedural. To be on top, the industry players should look for:
1. Real-time Safety Data
Data transparency in pharmacovigilance has always been a key factor in defining PV practices. In 2026, too, it’s going to be the strongest aspect as global regulators are keenly emphasising the need for timely, interpretable safety information. They are focusing more on new models of digital reporting and automated surveillance. Regulators are not only expecting the mere ability to collect data but also the accurate interpretation of it from the companies. Hence, the industry players should align with the push toward transparency and real-time safety data. The EU is already witnessing a significant milestone in strengthening the EudraVigilance real-time monitoring system.
2. EU Regulation 2025/1466
The commencement of EU Regulation 2025/1466 reinforces the ability to collect, interpret, and share data. It clearly outlines the real-time accessibility of adverse event data, safety governance frameworks, and clear justifications to signal detections. As regulators move to full enforcement of EU Regulation 2025/1466 in 2026, MAHs should be prepared for frequent scrutiny of safety governance structures, deep-dive assessments of national-level variations in reporting, and accountability for the evidence sources used in benefit–risk evaluations. The EU Regulation 2025/1466 also sets clear expectations for post-authorisation safety studies (PASS), which are a key component of lifecycle safety evaluation.
3. PSMF for End-to-End PV Visibility
Many of the PV processes developed over the last decade are expected to be refined in 2026. One among them is the Pharmacovigilance System Master File (PSMF). It remains a cornerstone of compliance, but not as a static document. Agencies are expecting it to be more dynamic, bringing in real-time updates to system descriptions, version-controlled documentation showcasing organisational changes, and projects’ precise mapping of activities outsourced and vendor oversight. Ultimately, the PSMF should reflect readiness for inspection and should reinforce alignment across teams such as safety, regulatory, medical affairs, and quality.
4. ICH E2D(R2) for Global Harmonisation
ICH E2D (R2) is a draft guidance released in April 2025. It basically focuses on enhanced Individual Case Study Report (ICSR) formats, terminology updates, and alignment with AI and real-world data. It encourages uniform definitions of safety data sources and standardized approaches to literature surveillance. It will be beneficial for multinational organisations, as it is expected to support more consistent processes globally and to facilitate shared safety databases that comply with multiple authorities in parallel.
In conclusion, the regulatory momentum, being built through the above-mentioned aspects, is fundamentally reshaping how companies approach product and data safety. Organizations can stay on top of regulatory scrutiny by adopting pharmacovigilance compliance best practices, such as:
- strengthening data transparency,
- embedding risk-based pharmacovigilance into operations
Foster a culture of safety excellence throughout your PV practice. Demonstrate trust, accountability, and scientific rigor in every decision.