Industry opinion
Jan 21, 2026
Why ICH E2B(R3) still matters in 2026 – A conversation with Ducksang (David) Im
As pharmacovigilance continues to evolve, regulatory standards remain a cornerstone of patient safety and global compliance. One such standard, ICH E2B(R3), has been shaping safety reporting for years, but its relevance is stronger than ever. We sat down with Ducksang (David) Im, Chief Operations Officer at CRScube, to reflect on why E2B(R3) still matters in 2026, what it means for life sciences organisations today, and how cubeSAFETY was built with this reality in mind.
David, let’s start with the basics. Why is ICH E2B(R3) so important for safety reporting?
ICH E2B(R3) is essentially the global foundation for how Individual Case Safety Reports – or ICSRs – are exchanged electronically. Its role is critical because it ensures a high level of data granularity and interoperability between regulatory authorities and the life sciences industry. That consistency is what allows regulators to analyse safety data accurately, and ultimately, it plays a direct role in protecting patients.
What fundamentally changed when the industry moved from E2B(R2) to E2B(R3)?
The biggest shift was moving away from largely text-based reporting to a highly structured data model. With R3, we now have far more precise data elements, better traceability of case follow-ups and amendments, and clearer documentation of causality. This structure enables advanced automation and data mining, which simply wasn’t possible with R2.
Some might argue that E2B(R3) is “old news.” Why is it still so significant in 2026?
That’s a common misconception. While the standard itself has existed for some time, global adoption has been gradual. What makes 2026 critical is that many regulatory authorities worldwide have now finalized mandatory transitions. The FDA as an example is asking submitters to comply by the 1st of April 2026 with electronic submission requirements for premarketing IND safety reports for serious and unexpected suspected adverse reactions. For global organisations, compliance with E2B(R3) is no longer optional – it’s a prerequisite for market access.
What does this mean specifically for CRScube and cubeSAFETY?
For us, E2B(R3) isn’t an add-on. It’s at the core of cubeSAFETY’s architecture. The platform was designed to meet the most stringent data requirements from regulators like the FDA and EMA. That gives our clients confidence that they’re operating in a compliant, future-proof environment, even as regulations continue to evolve.
Does E2B(R3) impact other solutions within the CRScube platform?
Absolutely. The integration between our EDC, cubeCDMS, and cubeSAFETY relies heavily on the E2B(R3) standard. It allows safety data captured during clinical trials to flow seamlessly into the safety system without loss of data integrity or the need for manual re-entry, which is a major risk reduction point for our clients.
How did CRScube prepare for the transition to Release 3?
In pharmacovigilance, major regulatory changes are often announced years in advance. We used that lead time strategically. Instead of patching an existing system, our development team rebuilt the safety engine from the ground up to be natively R3-compliant. That decision has paid off in terms of performance, scalability, and long-term compliance.
How do you ensure cubeSAFETY remains compliant as standards evolve?
We have a dedicated regulatory intelligence team continuously monitoring guidance from ICH, the EMA, and the FDA. Combined with an agile development cycle, this allows us to roll out updates quickly and ensure our clients are always reporting using the latest E2B(R3) specifications.
E2B(R3) isn’t just a regulatory requirement, it’s a foundation for modern, intelligent pharmacovigilance. If you’d like to learn how cubeSAFETY helps you stay compliant while simplifying safety operations, get in touch with the CRScube team today.
Contact CRScube to learn more about cubeSAFETY
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