What is a PSUR?

A Periodic Safety Update Report (PSUR) is a pharmacovigilance report used to periodically evaluate the safety and benefit-risk profile of an authorised medicinal product.

It brings together relevant safety and benefit-risk information accumulated during a defined reporting period and helps determine whether new information has changed what is known about the medicinal product.

Why is a PSUR Prepared?

A PSUR helps marketing authorisation holders and regulatory authorities to:

• Review new and cumulative safety information.
• Evaluate important safety signals and risks.
• Identify changes in the known safety profile.
• Assess the continuing benefit-risk balance of the medicine.
• Determine whether further pharmacovigilance or risk-minimisation action may be required.

What Information Does a PSUR Consider?

Depending on applicable requirements, a PSUR may consider information from sources such as:

• Adverse reaction reports
• Clinical trials and studies
• Scientific literature
• Safety signals
• Patient exposure data
• Regulatory actions
• Relevant benefit and effectiveness information

The information is evaluated collectively rather than considering individual safety cases in isolation.

PSUR and PBRER

The Periodic Benefit-Risk Evaluation Report (PBRER) described in ICH E2C(R2) provides a harmonised format for periodic benefit-risk evaluation of marketed medicines.

In the European Union, the term PSUR continues to be used, while its format and content are based on the PBRER framework.

In Simple Terms

A PSUR provides a periodic overall review of what is known about a medicine’s safety and benefit-risk balance after authorisation.

It is an important part of ongoing pharmacovigilance and helps regulatory authorities determine whether a medicine can continue to be used under its existing conditions or whether additional safety measures may be necessary.

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