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Periodic Safety Update Reports (PSUR)

Updated

Periodic Safety Update Reports (PSUR) are comprehensive reports on the safety of a medical product that are submitted to regulatory authorities at regular intervals. PSURs are a critical component of pharmacovigilance, the science of detecting, assessing, and preventing adverse effects of medicines.

PSURs are typically prepared by pharmaceutical companies and provide an overview of the safety profile of a medical product over a defined period of time. The report includes a summary of all safety data that has been collected since the last PSUR was submitted, including data from clinical trials, spontaneous reports of adverse events, and any other safety-related information.

The content of a Periodic Safety Update Reports (PSUR) typically includes the following information:

  1. Executive summary: A brief summary of the main safety findings and conclusions of the report.
  2. Product information: A summary of the product’s characteristics, including its active ingredients, indications, and contraindications.
  3. Clinical trial data: A summary of any clinical trial data that has been collected since the last PSUR was submitted.
  4. Spontaneous adverse event reports: A summary of all adverse event reports that have been received since the last PSUR was submitted.
  5. Literature review: A review of any relevant scientific literature that has been published since the last PSUR was submitted.
  6. Safety assessment: An assessment of the safety profile of the medical product, including any new or emerging safety concerns.

By collecting and analyzing safety data over a defined period of time, PSURs help to identify safety signals and provide a comprehensive overview of the safety profile of a medical product. Regulatory authorities use PSURs to monitor the safety of medical products and to ensure that they remain safe for patients. Pharmaceutical companies use PSURs to identify safety concerns and to take appropriate action to ensure the safe use of their products. Ultimately, PSURs help to promote patient safety by identifying and preventing adverse effects of medicines.

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