Definition

A report submitted at defined intervals that evaluates the benefit-risk balance of a medicinal product and summarizes new safety information. Required post-authorisation.

Example

For most products, PSURs are submitted every 6 months for the first 2 years, then annually or as per the approved timetable.

Regulatory source

GVP Module VII, EU Regulation 726/2004

Common mistakes

Missing the DLP (data lock point) or submission deadline. Not integrating signal assessments and risk minimisation.

Inspector question

How do you determine the PSUR timetable and ensure timely submission?

Related terms