The ICH has adopted the E2D(R1) Guideline: Post-Approval Safety Data (Step 4, 15 September 2025).
A quiet but important moment for global pharmacovigilance.
No new slogans. No radical reinvention.
Just long-overdue clarity on things that have been debated for decades.
Let’s be honest, much of this is what good PV should have been doing all along:
⚙️ Organised Data Collection Systems (ODCS): if you collect data systematically (PSPs, MRPs), document it properly.
⚙️ Digital platforms: if you own it or control it, you monitor it. Simple.
⚙️ Solicited vs. spontaneous: no more grey zones.
⚙️ Day Zero for Literature ICSRs - starts when you have enough information, not when you conduct a search.
⚙️ “Other observations”: well recognised “third category” – not an ICSR, not and aggregate, and yet an important piece of information to share immediately.
⚙️ Outsourcing: delegation ≠ abdication. The MAH stays responsible. Always. Just in case someone thinks otherwise…
This isn’t disruption; it’s alignment. And the global system needed it.
What’s new is not the words, but the world around them: Digital ecosystems. Real-time signals. Patient communities speaking outside our systems.E2D(R1) acknowledges reality, that safety data no longer lives just inside PV databases.
Congratulations to the expert working group!
#Pharmacovigilance #ICH #DrugSafety
