Before we start considering what the future of pharmacovigilance will look like, should we not address first what it already could be today? We believe the current global spend on pharmacovigilance is actually much higher than it should be. Let’s dive into the topic more in this article.

Addendum II on masking of personal data in individual case safety reports (ICSR) submitted to EudraVigilance (EV) became effective on 25th of July 2025. What does that mean for MAHs in practice? In this blog post, we summarize the impact on several categories of ICSR fields and closely related areas.

Five years after our first blog post on pharmacovigilance automation, we’re reflecting on the topic from today’s perspective. This brings us to an important concept: With automation all around us, the question to ask isn’t just what we can automate, but what we want to keep human. We also touch on the paradox of how automation can significantly reduce tasks on one side, yet often create previously unseen volumes of new work on the other.

A blog post with article-by-article redline-style mapping from the December 2024 consultation draft of the EU PV Regulation Update to the final text adopted on 22 July 2025.
The most substantive shifts between draft and final amendment are related to deviations in PSMF, audits and EV monitoring by MAHs.