Ultragenic assisted one of the six leading companies, who were part of a US FDA initiated 2-phase pilot test program to finalize guidelines for submitting pre- and post-marketing individual case safety reports (ICSRs) in E2B R3 format with 28 additional data elements beyond the standard ICH requirements.
The Challenge
In July 2023, the US FDA initiated a 2-phase Pilot Test program involving six leading companies to finalize guidelines for submitting pre- and post-marketing Individual Case Safety Reports (ICSRs) in E2B R3 format. This program introduced 28 additional data elements beyond standard ICH requirements, aiming to capture specific information crucial for robust pharmacovigilance. Ultragenic provided assistance to one of the participants in the FDA’s testing program.
The challenge was that the client’s safety system faced limitations as it was unable to generate the additional data elements mandated by the FDA.
The Ultragenic Approach (Solution)
A Proof of Concept (POC) was executed to expand upon the standard E2B R3 Profile provided by the safety system. During this process, the respective XSLT files were updated on the application servers. These updates were essential for rendering a final HL7 format of E2B that fully adheres to the standards set forth by the FDA.
The Outcome
During the testing phase with the FDA, numerous issues were identified early on. For instance, the FDA enforced strict validation criteria, such as only accepting 6-digit Investigational New Drug (IND) numbers and rejecting dose units lacking Unified Code for Units of Measure (UCUM) codes. Additionally, certain European Union (EU) country codes were not accepted for specific data elements.
As of January 16, 2024, FDA accepts postmarketing ICSRs for human drugs in E2B(R3) format. Submitters have two years to comply. However, premarket ICSRs are not accepted yet. Updates on IND safety reporting guidance and acceptance of IND and IND-exempt BA/BE safety reports in E2B(R3) will follow.
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