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What is a PSUR

PSUR stands for Periodic Safety Update Report. It is a pharmacovigilance document that is required to be submitted to regulatory authorities, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), for all approved drugs on a regular basis.

The PSUR provides an overview of the safety profile of a drug over a specified period of time, typically 6 months to 1 year, and includes information about any adverse events (side effects) that have been reported during that time. The report also includes information about any changes to the drug’s labeling or prescribing information, as well as updates on the drug’s efficacy and use.

The purpose of the PSUR is to evaluate the overall safety and benefit-risk profile of a drug and to identify any new safety concerns or trends that may require further investigation or action, such as changes to the drug’s labeling or restrictions on its use.

The PSUR is prepared by the marketing authorization holder (MAH) or sponsor of the drug, and is based on data from clinical trials, post-marketing studies, and spontaneous reports of adverse events from healthcare professionals and patients. The report is reviewed by regulatory authorities, who may request additional information or take regulatory action if necessary.

Overall, the PSUR is an important tool for monitoring the safety of drugs over time and ensuring that they continue to be safe and effective for patients.

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