Title:Overview of Periodic Safety Update Reports: Where Have We Reached?
Volume: 7
Issue: 1
Author(s): Ruchika Sharma, Kamal Kant and Anoop Kumar*
Affiliation:
- Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research (NIPER-Raebareli), Lucknow (UP),India
Keywords:
PSUR, PBRER, module VII, ADRs, pharmacovigilance, pharmaceutical companies.
Abstract: 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? Understanding
of 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.
