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.

Since 2022, there has been a continuous effort from EMA to implement the Product Data Management Services (PMS), a system designed to replace XEVMPD. How far are we now, three years later?