• PSURs are pharmacovigilance documents that provide risk-benefit balance assessment. • The notion of PSUR is to offer a wide and complex evaluation of risk-benefit balance of a medicinal product. • PSUR reporting first came into existence in 1992. • Purpose of PSUR is to provide an update of global safety experience with a specific pharmaceutical. • It is imperative to consult the guideline on good pharmacovigilance practices (GVP) while preparing PSUR. • MAHs are supposed to submit all PSURs in EU to the central PSUR repository. To Continue Reading : https://bit.ly/34ViVDb pharmacovigilance Services : https://bit.ly/2wM7IIH Contact Us: Website : https://bit.ly/33Fwsye Email us: [email protected] Whatsapp: +91 9884350006