Periodic Reporting in Pharmacovigilance

Periodic reporting in pharmacovigilance is the scheduled submission and evaluation of cumulative safety information for medicinal products during clinical development and after marketing authorisation.

While individual case safety reports (ICSRs) communicate safety information concerning individual cases, periodic safety reports provide a broader assessment of accumulated safety data over a defined reporting period.

Purpose of Periodic Reporting

Periodic reporting enables sponsors, marketing authorisation holders and regulatory authorities to periodically review the evolving safety profile of a medicinal product.

Its major objectives include:

• Reviewing new and cumulative safety information.
• Identifying new or changing safety concerns.
• Evaluating important identified and potential risks.
• Assessing relevant safety signals.
• Reviewing changes in the known safety profile.
• Evaluating the benefit-risk balance where applicable.
• Determining whether additional pharmacovigilance or risk-minimisation activities may be necessary.

Periodic reporting therefore complements individual case reporting and other pharmacovigilance activities.

Periodic Reporting During Clinical Development

During clinical development, the principal periodic safety report for an investigational drug is the Development Safety Update Report (DSUR).

The DSUR provides a comprehensive annual review of relevant safety information collected during the reporting period for an investigational drug.

It is intended to provide regulators with an assessment of the evolving safety profile of the investigational drug while clinical development is continuing.

The DSUR is described in ICH E2F – Development Safety Update Report.

Periodic Reporting After Marketing Authorisation

Following marketing authorisation, periodic reporting supports continuing assessment of the safety and benefit-risk profile of a medicinal product.

An important post-authorisation report is the Periodic Safety Update Report (PSUR).

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

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

Information Considered in Periodic Reports

Depending on the report type and applicable regulatory requirements, periodic reports may consider information such as:

• Worldwide marketing-authorisation status
• Actions taken for safety reasons
• Exposure to the medicinal product
• Individual and cumulative safety data
• Findings from clinical trials
• Non-interventional studies
• Scientific literature
• Safety signals
• Relevant non-clinical information
• Risk evaluation
• Benefit information, where applicable
• Overall benefit-risk assessment

The information included depends on the purpose of the report and the applicable regulatory framework.

Reporting Periods and Data Lock Points

Periodic reports evaluate information collected within defined reporting periods.

A Data Lock Point (DLP) establishes the cut-off date for data included in a particular periodic report. Information received after the DLP is generally considered according to the requirements applicable to subsequent reporting or significant new safety information.

Reporting frequency should not be assumed to be identical for every medicinal product.

It may depend on:

• Stage of product development
• Type of report
• Marketing-authorisation status
• Product-specific requirements
• Applicable national or regional regulations
• Requirements specified by regulatory authorities

EU PSUR Reporting

Within the European Union, PSUR submission requirements for authorised medicinal products are determined according to applicable legislation and product-specific requirements.

The European Union Reference Dates (EURD) list, where applicable, specifies the frequency of PSUR submission and associated data lock points for active substances and combinations of active substances.

Marketing authorisation holders should therefore verify the current EURD list and other applicable requirements when determining whether and when a PSUR must be submitted.

Regulatory Assessment

Periodic reports are reviewed by regulatory authorities to determine whether the safety profile or benefit-risk balance of a medicinal product has changed.

The assessment may lead to:

• Continued monitoring
• Requests for additional information
• Further investigation of safety signals
• Updates to product information
• Additional pharmacovigilance activities
• Risk-minimisation measures
• Other regulatory actions when appropriate

Importance of Periodic Reporting

Periodic reporting provides a structured mechanism for reviewing safety information at defined intervals throughout the medicinal-product lifecycle.

Together with individual case reporting, signal management, aggregate analysis and risk management, it supports continuous pharmacovigilance and informed regulatory decision-making.

You may be interested in the programs below: