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

(E-pub Ahead of Print)

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

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

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Periodic safety update report (PSUR) is now known as the Periodic Benefit-Risk Evaluation Report (PBRER). In July 2012, as per 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 lesiglation mainly focus on benefit risk assessment of medicinal product and did promises much more, it’s almost more than 4 years passed, but how much new lesiglation able to deliver is still unclear. In the literature, various articles have been published regarding new lesiglation module VII but none of them highlights the differences between old and new lesiglation, How much success we got?, What challenges we are facing?. The understanding all these points is the need of hour for Pharmacovigilance audience which will be helpful to implement the Pharmacovigilance (PV) in more efficient and effective way. Thus, in this article, we try to explain the differences between new and old lesiglation 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.

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(E-pub Ahead of Print)
DOI: 10.2174/2213476X06666190823151514

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