Periodic Safety Update Reports (PSUR)

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

PSURs bring together relevant new and cumulative information so that marketing authorisation holders and regulatory authorities can determine whether the product’s safety profile or benefit-risk balance has changed and whether further regulatory or risk-minimisation action is required.

Purpose of a PSUR

The principal objectives of a PSUR are to:

• Present relevant new safety information.
• Evaluate cumulative safety data.
• Review important identified and potential risks.
• Assess new or changing safety signals.
• Evaluate relevant benefit information.
• Assess the overall benefit-risk balance of the medicinal product.
• Identify whether additional pharmacovigilance or risk-minimisation activities are required.

A PSUR therefore goes beyond simply listing adverse events. It provides a critical scientific evaluation of the information available during the reporting period in the context of cumulative knowledge about the product.

Sources of Information

Depending on applicable requirements and the product concerned, a PSUR may consider information from sources such as:

• Spontaneous adverse reaction reports
• Clinical trials
• Non-interventional studies
• Scientific and medical literature
• Regulatory authority information
• Safety signals
• Exposure data
• Relevant non-clinical information
• Other sources relevant to safety or benefit-risk evaluation

PSUR and PBRER

The Periodic Benefit-Risk Evaluation Report (PBRER) was introduced through ICH E2C(R2) as a harmonised format for periodic benefit-risk evaluation of marketed medicinal products.

In the European Union, the term PSUR continues to be used in legislation, while the format and content of the report are based on the PBRER described in ICH E2C(R2).

The modern periodic report therefore places significant emphasis on integrated benefit-risk evaluation, rather than safety information being considered in isolation.

Main Areas of a PSUR

A PSUR/PBRER generally addresses areas such as:

• Worldwide marketing authorisation status
• Actions taken for safety reasons
• Changes to reference safety information
• Patient exposure
• Summary data from clinical trials
• Post-marketing safety information
• Findings from studies
• Information from other clinical trials and sources
• Scientific literature
• Safety signals and risk evaluation
• Benefit evaluation
• Integrated benefit-risk analysis
• Conclusions and proposed actions

The precise content should follow the applicable regulatory requirements and current guidance.

Reporting Frequency

PSUR submission frequency is not identical for every medicinal product or jurisdiction.

Within the European Union, submission requirements are determined by applicable legislation, conditions of the marketing authorisation and, where relevant, the European Union Reference Dates (EURD) list.

The EURD list specifies data lock points and PSUR submission frequencies for listed active substances and combinations.

Marketing authorisation holders should therefore verify current product-specific and jurisdiction-specific requirements rather than applying a general reporting schedule.

Regulatory Assessment

Regulatory authorities assess PSURs to determine whether new information affects the benefit-risk balance of a medicinal product.

The assessment may result in:

• Continued routine monitoring
• Requests for additional information
• Further investigation of safety concerns
• Changes to product information
• Additional pharmacovigilance activities
• Risk-minimisation measures
• Other regulatory action when necessary

Importance of PSURs

PSURs provide a structured mechanism for periodically evaluating the evolving safety and benefit-risk profile of authorised medicinal products.

Together with individual case reporting, signal management, risk management and other pharmacovigilance activities, PSURs contribute to the continuing protection of patients throughout the post-authorisation lifecycle of a medicine.

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