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This document provides guidance for applicants on submitting the Periodic Benefit-Risk Evaluation Report (PBRER) in place of the Periodic Adverse Drug Experience Report (PADER) or the Periodic Adverse

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What is periodic adverse drug experience?

Periodic adverse drug experience refers to the regular reporting of any negative or harmful effects caused by a drug. These adverse drug experiences can include side effects, allergic reactions, or any other unexpected or undesirable outcomes associated with the use of a medication.

Who is required to file periodic adverse drug experience?

Pharmaceutical companies, drug manufacturers, and regulatory authorities are typically required to file periodic adverse drug experience reports. These reports help monitor the safety and effectiveness of drugs on the market and ensure that any potential risks or issues are identified and addressed.

How to fill out periodic adverse drug experience?

Filling out a periodic adverse drug experience report usually involves collecting information about the specific adverse event, such as the drug involved, the patient demographics, the nature and severity of the event, and any contributing factors. This information is typically submitted through a standardized reporting form or system provided by the regulatory authority or governing body responsible for monitoring drug safety.

What is the purpose of periodic adverse drug experience?

The purpose of periodic adverse drug experience reporting is to monitor the safety and effectiveness of drugs on the market. By collecting information on adverse events related to drug use, regulatory authorities can identify patterns, potential risks, and take appropriate actions, such as updating prescribing information, issuing warnings or recalls, or conducting further investigations.

What information must be reported on periodic adverse drug experience?

The information typically required to be reported on a periodic adverse drug experience includes the identification of the drug involved, details about the adverse event (e.g., date, nature and severity), patient demographics (e.g., age, gender), any contributing factors, and contact information of the person reporting the event. The specific reporting requirements may vary depending on the regulatory authority or governing body responsible for drug safety monitoring.