In August 2024, the U.S. Food and Drug Administration (FDA) released the “FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products.” This technical specifications document provides detailed instructions for the electronic submission of Individual Case Safety Reports (ICSRs) in the E2B(R3) format to the FDA’s Adverse Event Reporting System (FAERS). U.S. Food and Drug Administration
Background
The ICH E2B(R3) guideline, developed by the International Council for Harmonisation (ICH), standardizes the electronic transmission of ICSRs globally. The FDA’s implementation guide aligns with this international standard while incorporating region-specific elements to meet the unique requirements of the U.S. regulatory environment. U.S. Food and Drug Administration
Key Features of the FDA Implementation Guide
- Regional Data Elements: The guide introduces FDA-specific data elements and controlled terminologies that complement the ICH E2B(R3) standard. These additions ensure that the information submitted meets the FDA’s regulatory and safety monitoring needs. U.S. Food and Drug Administration
- Submission Process: It details the technical approach for preparing electronic submissions, including the use of the FDA Electronic Submissions Gateway (ESG). The guide outlines the necessary steps for establishing ESG accounts, testing connectivity, and ensuring successful transmission of ICSRs. U.S. Food and Drug Administration
- Controlled Terminology and Coding: Emphasizing the use of standardized coding systems, the guide supports the implementation of controlled terminologies such as the Medical Dictionary for Regulatory Activities (MedDRA) for adverse event terms and the National Cancer Institute’s Enterprise Vocabulary Services (NCI EVS) for region-specific codes. U.S. Food and Drug Administration
- Technical Specifications: The document provides comprehensive technical specifications, including XML file structures, batch and message wrapper information, and detailed instructions for populating each data element. This ensures consistency and accuracy in the data submitted to FAERS. U.S. Food and Drug Administration
- Acknowledgment and Error Handling: It outlines the FDA’s acknowledgment process for submissions, detailing the types of acknowledgments senders will receive and guidance on addressing errors or validation issues that may arise during submission. U.S. Food and Drug Administration
Impact on Stakeholders
For pharmaceutical companies, biologics manufacturers, and other stakeholders involved in drug safety reporting, this implementation guide is a critical resource. It facilitates compliance with FDA reporting requirements, enhances the quality of safety data, and supports the FDA’s mission to monitor and ensure the safety of drug and biological products effectively.
Conclusion
The FDA’s “Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports” represents a significant step toward harmonizing drug safety reporting standards. By aligning with international guidelines and incorporating region-specific requirements, the FDA aims to streamline the reporting process, improve data quality, and ultimately protect public health.U.S. Food and Drug Administration
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
By Shudarsana Company