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.

Once we’ve moved the industry to the modern day and automated away all of the routine PV work, what will happen to all the current pharmacovigilance jobs? In this article, we share our views on what we believe is the future of pharmacovigilance, given changes in the way modern services are provided.