This blog features:
- An overview of E2B cases in pharmacovigilance and their significance
- Key differences between E2B cases and other types of pharmacovigilance cases
- How E2B case processing differs from conventional case processing workflows
Introduction
If you work in a Drug Safety or Pharmacovigilance department, you have likely come across the term “E2B case” — whether in team discussions, case assignments, or your safety database. But what exactly makes a case an E2B case, and how does it differ from the cases you process every day?
This article walks you through everything you need to know about E2B cases, how they are classified, and what makes their processing workflow unique
E2B case: An overview
In pharmacovigilance, E2B cases refer to Individual Case Safety Reports (ICSRs) that are received, exchanged, or imported electronically using the ICH E2B standard — in the form of an XML file.
These cases are typically pre-processed or assessed at a basic level by the originating party before being transmitted. They are exchanged between companies, regulatory authorities, and partners through a defined electronic format, and are loaded directly into the receiving organization’s safety database.
At their core, E2B cases are like any other case in pharmacovigilance — they:
- Report adverse events
- Contribute to patient safety monitoring
- Follow ICH E2B guidelines
- Are submitted to regulatory authorities
The distinction lies entirely in how they reach your database and who processed them first.
“E2B cases transform pharmacovigilance from manual reporting into a globally connected safety communication system.”
E2B cases vs Other cases
| E2B Cases | Other cases | |
|---|---|---|
| Source | Received as an E2B XML file from a partner, MAH, or authority | Received directly from the reporter (HCP, patient, Literature) |
| Prior processing | Pre-processed or assessed by a third party (or any company/any other database) before your initial receipt | Initiated and processed by other XML source by your company |
| Data entry | minimal data entry is enough | Manual data entry from the source |
| Case type | Any type | Classified based on the primary reporting source |
| Submission | May already submitted or being format changed from any other requires submission | Processed and submitted to any regulators in regular E2B formats based on regulatory |
Challenges in managing E2B cases
While E2B cases reduce manual entry burden, they introduce their own set of challenges:
- Duplicate detection
- Follow up management
- MedDRA re-coding
- Format conversion and mapping issues in during database adoption
E2B cases and processing
- The adverse event report is received as an XML file, already processed by a
third party, and is automatically imported into the safety database with
minimal manual data entry required. - The E2B XML file enters the safety database through the safety system
gateway. Once received, the report is automatically loaded into the “Incoming
E2B Reports” tab or the ESM Staging Area of the safety database. - The associate then accesses the case from the Incoming Area, reviews the
imported data for completeness and accuracy, and progresses it through the
standard workflow — medical coding, quality review, narrative, and submission.
Need Support with E2B Case Processing?
At Drugvigil, we deliver specialized E2B and pharmacovigilance solutions backed by experienced safety professionals and dedicated in-house tools.
Our services include E2B case generation, XML conversion, E2B(R2) to E2B(R3) migration, database migration, validation support, and regulatory submissions to global health authorities.
Whether you require seamless safety data migration or reliable E2B management support, our team is equipped to streamline and strengthen your pharmacovigilance operations.
Conclusion
E2B cases are not a fundamentally different category of adverse event — they are the same ICSRs you work with every day, just arriving through a different channel. What sets them apart is their origin and intake method: pre-processed by a third party and delivered as an E2B XML file directly into your safety database, rather than manually entered from a source document.
As most common safety database handling B system and more often adopting with E2B imports for easy navigation and submission.
As regulatory expectations around electronic reporting continue to evolve — particularly with the global shift toward E2B(R3) — familiarity with E2B case handling is becoming a core competency for anyone in drug safety and pharmacovigilance. Knowing where these cases come from, what challenges they carry, and how their processing differs from standard cases will make you a more effective and confident safety professional.
