What Is the Difference Between Pbrer and Dsur? A Guide to Pharmacovigilance Reporting

October 8, 2025 •

3 min read

According to the International Council for Harmonisation (ICH), aggregate safety reports provide a systematic, periodic collection and synthesis of safety information. Understanding the difference between Pbrer and Dsur is therefore critical for pharmaceutical sponsors, as these documents serve distinct purposes during different phases of a drug’s lifecycle. This guide delves into the specific roles, timing, and content of each regulatory filing.

Quick Summary

PBRER provides a post-marketing benefit-risk evaluation for an approved drug, whereas DSUR assesses the safety profile of an investigational drug during its clinical development.

Key Points

Lifecycle Stage Defines Report: The DSUR covers the pre-marketing, clinical development phase, while the PBRER is for a post-marketing, approved drug.
Distinct Purposes: The DSUR aims to monitor safety risks for clinical trial participants, whereas the PBRER assesses the broader benefit-risk balance for an authorized product.
Different Timelines: DSUR submission is based on the Development International Birth Date (DIBD), while PBRER is triggered by the International Birth Date (IBD).
Content and Scope Differ: The DSUR focuses on investigational data, while the PBRER synthesizes data from multiple sources, including both clinical trials and real-world post-marketing use.
Harmonization Efforts Minimize Duplication: To reduce redundant work, the ICH provides guidelines for sharing content between DSUR and PBRER, especially when a marketed drug is still under further study.

What are PBRER and DSUR?

Both the Periodic Benefit-Risk Evaluation Report (PBRER) and the Development Safety Update Report (DSUR) are mandatory pharmacovigilance documents required by global regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Mandated by the International Council for Harmonisation (ICH), they ensure the ongoing assessment of a drug's safety profile throughout its lifecycle. While both reports focus on patient safety, their scope, purpose, and timing are fundamentally different, reflecting the distinct stages of a drug’s journey from clinical investigation to widespread market use.

The Role and Scope of a PBRER

The PBRER is a post-marketing regulatory report that provides a comprehensive evaluation of the benefit-risk balance of an authorized medicinal product. As a drug is marketed, it's exposed to a larger population, revealing potential risks. The PBRER evaluates real-world data at defined intervals to ensure the product remains safe and effective.

Key aspects of a PBRER include:

Purpose: To evaluate new or emerging safety information for a marketed product and its benefit-risk balance.
Trigger: The reporting period is based on the International Birth Date (IBD), the date of the first marketing authorization globally.
Frequency: Submissions are at specified intervals after authorization, typically varying by region.
Content: The report analyzes cumulative safety data from various sources, including post-marketing studies and spontaneous reports.

The Role and Scope of a DSUR

The DSUR is a pre-marketing regulatory report for drugs under clinical investigation. It provides an annual summary of the safety profile of an investigational drug, helping monitor and manage risks during development. The DSUR is vital for protecting clinical trial participants.

Key aspects of a DSUR include:

Purpose: To assess the safety profile of an investigational drug in clinical development.
Trigger: The reporting period is based on the Development International Birth Date (DIBD), the date of the first clinical trial authorization globally.
Frequency: DSURs are submitted annually, typically within 60 days of the DIBD anniversary, until clinical studies are completed.
Content: The report focuses on cumulative and interval safety data from clinical trials, including serious adverse events and new safety concerns.

Overlap and Harmonization

When a product is both marketed and still undergoing clinical investigation, both PBRER and DSUR may be required. ICH guidelines promote harmonization, allowing for sharing content between reports to minimize duplication. The DSUR can be seen as a subset of the PBRER, focusing on ongoing trials.

Key distinctions between DSUR and PBRER

Lifecycle Stage: DSUR covers pre-marketing clinical development, PBRER covers post-marketing.
Focus: DSUR focuses on investigational drug safety in trials, PBRER evaluates the benefit-risk balance of an approved product.
Triggering Date: DSUR uses DIBD, PBRER uses IBD.
Reporting Frequency: DSUR is generally annual, PBRER frequency varies.
Patient Population: DSUR reports on trial participants, PBRER includes all marketed product patients.

Conclusion

While both PBRER and DSUR are vital for pharmacovigilance, their main difference is the drug lifecycle stage they address. The DSUR is for drugs in development, prioritizing trial participant safety. The PBRER is for approved products, evaluating the benefit-risk profile for the wider population. Both, guided by ICH standards, reinforce the commitment to safety monitoring. For more details on guidelines, the FDA provides resources like the E2C(R2) Periodic Benefit-Risk Evaluation Report guidance.

Comparison of PBRER vs. DSUR


Feature	DSUR (Development Safety Update Report)	PBRER (Periodic Benefit-Risk Evaluation Report)
Drug Status	Investigational (under development)	Marketed (authorized for sale)
Primary Objective	Assess and monitor the safety profile during clinical development.	Evaluate the overall benefit-risk balance of the product in a marketed setting.
Reporting Trigger	Development International Birth Date (DIBD), based on first clinical trial authorization.	International Birth Date (IBD), based on first marketing authorization.
Target Population	Clinical trial participants and patients in ongoing trials.	All patients exposed to the marketed product globally.
Reporting Frequency	Annually, typically until all clinical trials are complete.	Varies, often semi-annually or annually for the first few years, then less frequently.
Regulatory Framework	ICH E2F Guideline.	ICH E2C(R2) Guideline.
Data Sources	Clinical trials, safety findings from non-clinical studies, literature.	Clinical trials, post-marketing data, spontaneous reports, registries.

Frequently Asked Questions

The primary purpose of a Development Safety Update Report (DSUR) is to provide an annual overview and critical assessment of the safety profile for an investigational drug during its clinical development phase.

The primary purpose of a Periodic Benefit-Risk Evaluation Report (PBRER) is to offer a comprehensive evaluation of the overall benefit-risk balance of a medicinal product that has received marketing authorization.

A DSUR is typically submitted annually, within 60 calendar days of the Development International Birth Date (DIBD), which is the date of the first clinical trial authorization anywhere in the world.

A PBRER is submitted at periodic intervals after marketing authorization. The frequency can vary, often starting more frequently and becoming less frequent over time, and is based on the International Birth Date (IBD).

Yes, if a drug is both marketed and involved in ongoing clinical trials, regulatory requirements in some regions may necessitate the submission of both a PBRER and a DSUR.

A PBRER includes cumulative safety data from various sources, such as clinical trials, spontaneous reports, and other real-world data collected since the drug entered the market.

International guidelines, like those from the ICH, have been established to allow companies to share and reuse content between DSUR and PBRER when appropriate, minimizing duplicated effort, particularly when submission dates are aligned.