Overview of Periodic Safety Update Reports: Where Have We Reached?

Author(s): Ruchika Sharma, Kamal Kant, Anoop Kumar*

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Continued as Applied Drug Research, Clinical Trials and Regulatory Affairs

Volume 7 , Issue 1 , 2020

Graphical 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.

Keywords: PSUR, PBRER, module VII, ADRs, pharmacovigilance, pharmaceutical companies.

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Article Details

Year: 2020
Published on: 03 March, 2020
Page: [4 - 11]
Pages: 8
DOI: 10.2174/2213476X06666190823151514

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