Understanding the Vital Difference Between PSUR and ICSR in Pharmacovigilance

October 8, 2025 •

5 min read

According to the European Medicines Agency (EMA), pharmacovigilance documents like PSUR and ICSR are fundamental to monitoring drug safety throughout its lifecycle. This article clarifies what is the difference between PSUR and ICSR, detailing their distinct roles and purposes in safeguarding public health.

Quick Summary

A PSUR is an aggregate report evaluating a drug's overall benefit-risk balance over a specified period, while an ICSR details a single suspected adverse event in one patient.

Key Points

Scope and Detail: An ICSR documents a single adverse event with high detail, whereas a PSUR is an aggregate report summarizing cumulative safety data.
Reporting Frequency: ICSRs are submitted in an expedited manner for serious cases, while PSURs follow a predefined, periodic schedule (e.g., annually).
Primary Purpose: The main purpose of an ICSR is to report and track individual safety cases, whereas the PSUR's purpose is to evaluate the overall benefit-risk balance of a drug.
Data Aggregation: An ICSR serves as a raw data point, while a PSUR is built upon the aggregation and analysis of data from numerous ICSRs, studies, and other sources.
Regulatory Action: ICSRs can lead to immediate, case-specific actions, while PSURs inform broader regulatory decisions like product label updates.
Lifecycle Phase: ICSRs can be generated from both clinical trials and post-marketing sources, but PSURs are primarily post-marketing surveillance reports.

In the field of pharmacovigilance, the terms Individual Case Safety Report (ICSR) and Periodic Safety Update Report (PSUR) are crucial for monitoring and maintaining the safety of medicinal products once they are on the market. While both serve to protect patient safety and inform regulatory bodies, they differ fundamentally in their scope, purpose, and reporting timelines. The ICSR is a granular, immediate report focusing on a single event, whereas the PSUR is a periodic, cumulative summary that provides a broader perspective on a product's safety profile. Understanding their specific functions is vital for pharmaceutical companies, regulators, and healthcare professionals involved in drug safety.

What is an Individual Case Safety Report (ICSR)?

An Individual Case Safety Report (ICSR) is a document detailing a single, suspected adverse reaction to a medical product experienced by a single patient at a specific point in time. The primary goal of an ICSR is to capture and transmit initial information about potential safety issues quickly, allowing for immediate action if necessary. These reports are a cornerstone of pharmacovigilance, as they form the raw data from which broader safety trends and signals are detected over time.

Key components of an ICSR

ICSRs contain comprehensive details that are necessary for regulatory review. These typically include:

Patient information: Demographics such as age, gender, and weight, along with relevant medical history.
Adverse event information: A description of the event, its outcome, and the date it occurred.
Suspect medical product information: Details about the drug, including its name, dosage, and start/end dates of treatment.
Reporter information: The name and contact information of the person who reported the event, which could be a healthcare professional, a consumer, or a manufacturer's representative.

ICSR reporting timelines

Due to the individual nature and potential seriousness of the events, ICSRs are subject to expedited reporting timelines, especially for serious adverse events. Depending on the specific regulatory requirements and the nature of the event (e.g., serious vs. non-serious), a report may need to be submitted within days or a few weeks of becoming aware of the event. This immediate reporting is critical for detecting urgent safety concerns.

What is a Periodic Safety Update Report (PSUR)?

In contrast to the individual focus of an ICSR, a Periodic Safety Update Report (PSUR), now often referred to as a Periodic Benefit-Risk Evaluation Report (PBRER) internationally, is an aggregate report. It provides a comprehensive, cumulative overview of a medicinal product's safety and benefit-risk profile after it has been authorized for marketing. The PSUR evaluates all relevant safety data from a specified reporting interval, putting it in context with cumulative data and information from all sources.

Purpose of a PSUR

The main purpose of a PSUR is to allow regulatory authorities to periodically reassess the overall benefit-risk balance of a marketed product. It provides a proactive look at the accumulating safety data to determine if there are any new risks, changes in existing risks, or impacts on the product's overall safety profile. This is crucial for identifying less common or long-term adverse reactions that may not be apparent from individual ICSRs alone. Based on the PSUR's findings, regulatory actions like label updates or further studies may be required.

Sources of data for a PSUR

A PSUR draws on a wide range of data sources, including:

All ICSRs received during the reporting period.
Cumulative case reports from the product's marketing history.
Clinical trial findings, both non-clinical and post-marketing observational studies.
Published scientific literature and abstracts.
Signal detection reports and risk management plan activities.
Estimated patient exposure data.

PSUR vs. ICSR: A Direct Comparison

To highlight the fundamental differences, here is a comparison table outlining the key aspects of ICSRs and PSURs.


Feature	Individual Case Safety Report (ICSR)	Periodic Safety Update Report (PSUR)
Scope	Focuses on a single case of a suspected adverse event in a single patient.	Provides an aggregate, cumulative summary of a product's safety profile over a defined period.
Timing	Expedited reporting for urgent or serious events (e.g., within 7, 15, or 30 days).	Periodic reporting, typically on a schedule (e.g., every 6 months, annually, or as specified).
Purpose	To capture initial, specific details of a suspected adverse event to inform immediate regulatory action.	To provide a comprehensive, critical evaluation of the product's overall benefit-risk balance.
Data Source	Information comes directly from the reporter of the individual case.	Gathers and analyzes data from numerous sources, including individual ICSRs, clinical trials, and literature.
Detail Level	Highly detailed, narrative-based documentation of a specific event and patient.	Summary and statistical analysis of safety data trends, not individual case narratives.
Trigger	The receipt of a report about a suspected adverse event.	A predetermined data lock point (DLP) for the reporting period.
Review Action	Case-by-case assessment and entry into a safety database.	A comprehensive review by regulatory authorities leading to broader safety decisions.

The Interdependence of PSUR and ICSR

While distinct, the ICSR and PSUR are not independent entities but rather two complementary pieces of a larger pharmacovigilance system. The ICSR provides the raw, individual data points that are meticulously collected and processed by pharmaceutical companies. These individual reports are then aggregated and analyzed over time to create the broader picture presented in the PSUR. This relationship ensures that immediate, urgent safety issues are addressed promptly via ICSRs, while long-term, cumulative safety trends are systematically evaluated and addressed via PSURs. Without the steady flow of individual case reports, the aggregated analysis in a PSUR would not be possible. The system works hand-in-hand to provide both real-time monitoring and holistic safety assessment, fulfilling the pharmaceutical company's responsibility to monitor the safety of its products throughout their lifecycle. For more information, the European Medicines Agency offers detailed guidelines on good pharmacovigilance practices on their website.

Conclusion

In summary, the core difference between PSUR and ICSR lies in their level of detail, frequency, and purpose. An ICSR is a detailed, expedited report of a single adverse event, while a PSUR is a cumulative, periodic report evaluating a drug's overall safety profile. Together, they form a robust, multi-layered approach to pharmacovigilance that ensures drug safety from the individual patient level up to the global regulatory level, allowing for both timely intervention and long-term risk-benefit assessment.

Frequently Asked Questions

Marketing Authorization Holders (MAHs), typically pharmaceutical companies, are responsible for collecting ICSR data and preparing both ICSRs and PSURs for submission to regulatory authorities.

The submission timeline for an ICSR varies based on the seriousness and nature of the adverse event. Serious adverse events often require expedited reporting, such as within 7 or 15 days of becoming aware of the event, while non-serious events have longer reporting windows.

PSURs are submitted periodically, with the frequency determined by regulatory requirements and the drug's market age. For newer drugs, this may be every six months, becoming annual and then longer-term (e.g., every five years) for established products.

While a single ICSR might contribute to a safety signal, it is usually the aggregated findings over many ICSRs, as summarized in a PSUR, that lead to a formal regulatory request for a change in a drug's labeling or safety information.

While the term originated for drugs, the concept of a PSUR has been adapted for other medical products, including medical devices, which have similar post-market surveillance requirements under regulations like the EU MDR.

If a PSUR identifies a new or emerging safety signal, the regulatory authority may require further investigation or action from the Marketing Authorization Holder. This could lead to a label update, a risk minimization measure, or a request for additional studies.

PBRER (Periodic Benefit-Risk Evaluation Report) is the modern, international standard for the PSUR, as defined by the ICH. While the core purpose is the same—evaluating a drug's risk-benefit profile—the PBRER emphasizes the benefit evaluation more prominently than the original PSUR concept.