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Pharmacovigilance in 2026: What Regulation (EU) 2025/1466 Changes for Your Safety System
New EU pharmacovigilance rules apply from February 2026. Here is what changes for reporting, signal management and inspection readiness.
The PSMF: Keeping Your Pharmacovigilance House in Order
The Pharmacovigilance System Master File is the single document that describes how a company keeps its medicines safe. When an inspector arrives, it is often[…]
Nitrosamines: From Crisis Response to Business as Usual
What began as an urgent, industry-wide safety review of nitrosamine impurities has settled into a permanent feature of pharmaceutical quality management. The call-for-review deadlines have[…]
Nitrosamine Impurities: Managing a Risk That Has Not Gone Away
The regulatory deadlines for nitrosamine impurities have passed, but the obligation has not. What began in 2018 as an urgent response to contaminated sartans has[…]
The Pharmacovigilance System Master File: The First Document an Inspector Asks For
The pharmacovigilance system master file (PSMF) is the single document that describes how a marketing authorisation holder runs its safety system — and it is[…]
Risk Management Plans: Structure and Substance
A Risk Management Plan is not a formality appended to a dossier. It is the document in which you commit, in writing, to how a[…]
PSURs: Getting the Periodic Safety Update Right
The Periodic Safety Update Report is where a product’s benefit-risk balance is formally re-argued. Miss the deadline or the format, and a routine obligation becomes[…]
Signal Detection: Turning Safety Data into Action
Behind every label update and safety warning is a process that turns scattered adverse-event reports into a clear signal. Getting signal detection right is central[…]
The EU QPPV: Your Single Point of Accountability for Drug Safety
Every company marketing medicines in the EU must have one person permanently responsible for the safety of those products: the Qualified Person for Pharmacovigilance. It[…]