Nextrove has released Issue 2 – Q3 2026 of its Quarterly Pharmacovigilance and Regulatory Intelligence Bulletin, providing an overview of key regulatory developments shaping pharmacovigilance and drug safety requirements worldwide.
A major focus of this edition is the implementation of ICH E2D(R1) and its evolving impact on post-approval safety data management. The revised framework introduces important clarifications around Organized Data Collection Systems (ODCS), including patient support programs, market research activities and digital sources, with implications for case classification, documentation, reporting processes and pharmacovigilance oversight.
The bulletin examines developments across multiple regulatory regions, including the European Union and United States, while also covering important updates from the United Kingdom, Singapore, Saudi Arabia, Australia and South Africa.
Other topics featured in Issue 2 include changes to clinical trial safety reporting requirements, the use of AI in GxP inspection responses, post-approval pregnancy safety studies, real-world data and evidence, pharmacovigilance considerations for advanced therapy medicinal products, and the continued evolution of electronic safety reporting.
With regulatory expectations continuing to evolve across markets, understanding not only what has changed but also its potential operational impact is increasingly important for maintaining effective and compliant pharmacovigilance systems.
Explore Issue 2 of the Nextrove Quarterly Pharmacovigilance and Regulatory Intelligence Bulletin to stay informed and prepare for what’s ahead.