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Pharmacovigilance plays an important role in examining the safety of pharmaceutical product. Pharmacovigilance (PV) data are pivotal to make sure a safety and efficacy of medicines once the drugs get marketing approval. The periodic safety update report is a documental concept which is used as an important tool in pharmacovigilance to deliver a safety update of medicinal product to a society. The concept of PSUR was established in the year of 1992 and in November 1996, the ICH inscribe the ICH E2C i.e., the guideline for the periodic safety update report for the safety of marketed drugs. The periodic safety update report (PSUR) come up with a required process to control the drug marketing agencies to ensure that pharmaceutical products which are marketed does not harm the public health by their side effects.  Considering the importance PSUR in in drug safety, this article reviews the Significance, principal preparation of PSUR, objectives, timeline to submit the periodic safety update report as per the ICH E2C guidelines.

Keywords: Pharmacovigilance, Periodic safety update report, ICH E2C, Adverse drug effects