Introduction and Purpose
This document from the U.S. Food and Drug Administration (FDA) provides essential technical specifications for the electronic submission of Individual Case Safety Reports (ICSRs) and their attachments. It outlines the FDA's approach for incorporating regionally controlled terminology and adding specific data elements for pharmacovigilance reporting.
The specifications are designed for the submission of reports concerning drugs and biologics, excluding vaccines, in accordance with the International Conference on Harmonisation's (ICH) E2B(R3) standards.
Scope of Application
These guidelines apply to:
- Drug products with approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
- Prescription drug products marketed without an approved application.
- Nonprescription (over-the-counter) drug products marketed without an approved application.
- Biological products with approved Biologic License Applications (BLAs).
The document explicitly excludes submissions for prophylactic vaccines, whole blood, blood components, and human cellular/tissue-based products, as well as Investigational New Drug Safety Reports.
Submission Process
ICSRs must be prepared using the ICH E2B(R3) data elements and submitted in Extensible Markup Language (XML) format. Submissions are to be made through the FDA's Electronic Submissions Gateway (ESG).
Key aspects covered include:
- Technical approaches for receiving submissions and incorporating regional terminology.
- Handling of ICSR acknowledgments (ACK1, ACK2) and submission failures.
- Procedures for creating ICSR files, including batch and message wrapper information.
- Specific data elements for patient characteristics and drug information, including integration with ISO Identification of Medicinal Product (IDMP) standards.
Key Resources and Contacts
For further information and detailed guidance, stakeholders are directed to:
- The FDA's CBER ICSR Specifications Web page for vaccine-related submissions.
- The FDA Drugs guidance Web page for the ICH E2B(R3) Implementation Guide.
- The FAERS Electronic Submissions Web site for XML schema examples and procedures.
Contact information for inquiries is provided for the Office of Surveillance and Epidemiology (CDER) and the Office of Communication, Outreach and Development (CBER) within the FDA.
