What is the Origin of Periodic Safety Update Report?

The PSUR concept was formalized as part of international pharmacovigilance regulations, driven by the need for continuous, systematic monitoring of drugs once they are used by a large and diverse patient population in a real-world setting. This requirement ensures that any new or emerging safety signals are rapidly identified and acted upon by regulators.

What is the Mechanism of Periodic Safety Update Report?

The report systematically collates all relevant safety data, including individual case reports of adverse reactions, data from ongoing clinical trials, and information from the scientific literature. The mechanism involves a critical medical review and statistical analysis of this cumulative data to determine if the product's known risks have changed, if new risks have emerged, and whether the product information or marketing authorization requires updating.

Periodic Safety Update Report ∞ Area

Periodic Safety Update Report

Meaning

A Periodic Safety Update Report (PSUR) is a mandatory pharmacovigilance document prepared by a pharmaceutical company or marketing authorization holder to provide a comprehensive and critical analysis of a medicinal product’s worldwide safety experience post-authorization. This report is submitted to regulatory authorities at defined intervals to ensure the ongoing risk-benefit balance of the product remains favorable. It is a cornerstone of continuous drug safety surveillance.