Periodic safety update report (PSUR) is now known as the Periodic Benefit-Risk Evaluation
Report (PBRER). In July 2012, as per the new European Legislation, 16 Good Pharmacovigilance
Practices (GVP) modules came into effect by replacing Vol 9A guidelines. GVP
module VII provides the guidance for the preparation, submission and assessment of PSURs.
There are twice as many sections to the new PSUR as compared to ICH E2C (R1) document and
Volume 9A PSUR guidelines. The new legislation mainly focuses on benefit-risk assessment of
medicinal product and promises much more, but after more than 6 years, how much new lesiglation
is able to deliver is still unclear. In the literature, various articles have been published regarding
the new Legislation module VII but none of them have highlighted the differences between
old and new Legislation, How successful are we? What challenges are we facing? The understanding
all these points is the need of the hour for Pharmacovigilance audience which will be helpful
to implement the Pharmacovigilance (PV) in a more efficient and effective way. Thus, in this article,
we have explained the differences between new and old Legislation and when they come into
play. Finally, this article provides a brief examination of current challenges and future perspectives
of periodic safety update reporting.
