We have been missing an analysis by the EMA on effectiveness of their processes and the EU pharmacovigilance system as a whole. While we still need to wait for this, some conclusions can be made based on the publicly available data.

One of the key justifications for the current pharmacovigilance legislation was that ADRs “caused around 197,000 deaths per year in the EU.” We wanted to find out how the figure has changed since the regulations have been updated.

As a part of our research described in the previous post about LLS, we asked EMA if they have any plans to support the marketing authorization holders with this expensive legal obligation that typically produces little outcome. We have now received a response from the authority.

In this blog post, we briefly look at some of the key milestones in recent decades of the evolution of legislation and what it meant for pharmacovigilance operations in EU.