FDA´s Implementation Guide for ICH E2B (R3)

Recommendation

15/16 November 2023

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

The revised ICH E2B (R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) standardizes the definitions of data elements used in electronic transmission of different types of ICSRs, regardless of source and destination. Regional data elements are considered non-harmonized. However, the ICH XML file structure allows regions to use regionally controlled terminology and to add region-specific elements.

FDA´s regional ICH E2B (R3) Implementation Guideline (IG)

The FDA released a technical specifications document to assist interested parties in electronically submitting ICSRs to FDA´s Adverse Event Reporting System (FAERS) database. An ICSR is a description of an adverse experience related to an individual patient or subject. The ICH E2B (R3) Implementation Guideline (IG) applies to the following FDA-regulated products:

• Drug products marketed for human use with approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs)
• Prescription drug products marketed for human use without an approved application
• Nonprescription (over-the-counter) human drug products marketed without an approved application
• Biological products marketed for human use with approved biologic license applications (BLAs)
• Combination products with approved NDAs, ANDAs, or BLAs
• Investigational Medicinal Products (IMPs)

ICSRs should be prepared in accordance with the ICH E2B (R3) and FDA’s regional data elements, in extensible markup language (XML) file format and submitted through FDA’s Electronic Submissions Gateway (ESG). The agency´s information about electronic submissions will be periodically updated to reflect the evolving nature of the technology and the experiences of those using this technology.

More information is available in FDA´s Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products.