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Aggregate safety reports – PSURs

Aggregate safety reports – PSURs. A Periodic Safety Update Report (PSUR) is a type of aggregate safety report that is submitted to regulatory authorities on a regular basis. The purpose of a PSUR is to provide an up-to-date overview of the safety profile of a medicinal product, based on the latest available data.

Aggregate safety reports – PSURs are typically submitted annually, although the frequency may vary depending on the specific requirements of the regulatory authority. The report includes information on the adverse events associated with the product, as well as any new safety information that has become available since the last PSUR was submitted.

The PSUR is an important tool for regulatory authorities to assess the ongoing safety of a product and to identify any potential safety concerns. Based on the information contained in the PSUR, regulatory authorities may take action to modify the product’s labeling or risk management plan, or may request additional studies to further assess the safety of the product.

In order to ensure that the PSUR accurately reflects the latest available data, it is important to have systems in place for ongoing monitoring and reporting of adverse events. This may include conducting ongoing safety studies, monitoring the product’s use in real-world settings, and analyzing spontaneous adverse event reports.

In conclusion, PSURs are an important tool for the ongoing assessment of the safety of a medicinal product, and it is essential to ensure that they are accurate, complete, and up-to-date in order to meet the regulatory requirements and ensure the ongoing safety of the product.

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