Periodic Reporting in Pharmacovigilance

Periodic reporting in pharmacovigilance refers to the process of submitting safety reports to regulatory authorities at defined intervals, such as annually or every six months, for all approved drugs on the market. These reports provide an overview of the safety profile of the drug over a specified period of time and help to identify new safety concerns or trends that may require further investigation or action.

The two main types of periodic reports are the Periodic Safety Update Report (PSUR) and the Development Safety Update Report (DSUR).

The PSUR 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 report provides an overview of the safety profile of the 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 DSUR, on the other hand, is a report that is submitted during the clinical development of a drug, typically every six months or at the end of each phase of the clinical trials. The report provides an overview of the safety data collected during the clinical trials, including information about any adverse events or other safety concerns that have been identified.

Both the PSUR and DSUR are important tools for monitoring the safety of drugs on the market and ensuring that they continue to be safe and effective for patients. These reports help to identify new safety concerns or trends that may require further investigation or action, such as changes to the drug’s labeling or prescribing information, or the implementation of additional safety measures.

You may be interested in the programs below: