Best Practices for the Periodic Safety Update Report

The Periodic Safety Update Report (PSUR) is a critical tool for post-marketing safety evaluation. It provides an update on the worldwide safety experience of a medicinal product at defined time points after its authorization.

The Purpose of a Periodic Safety Update Report

The main objective of a Periodic Safety Update Report is to present a comprehensive and critical analysis of the risk-benefit balance of the product. It must include all new safety signals and any changes in the marketing status globally.

Critical sections of a PSUR include:

• Worldwide marketing authorization status.

• Actions taken in the reporting interval for safety reasons.

• Changes to Reference Safety Information (RSI).

• Estimated exposure and use patterns.

Failure to submit a Periodic Safety Update Report on time can lead to severe regulatory penalties and product suspension.