The revision of ICH E2D(R1) – Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs) marks a significant shift in how Marketing Authorisation Holders (MAHs) are expected to manage structured safety data collection activities.
This is not merely a technical update. It fundamentally reshapes how companies govern Organised Data Collection Systems (ODCS), Patient Support Programmes (PSPs), Market Research Programmes (MRPs), and digital platforms under their responsibility.
Importantly, this guideline has now been adopted by the CHMP, with an effective date of 18 March 2026, making it an expected regulatory standard within the EU framework.
As a result, companies are expected to perform an impact assessment and ensure alignment by the effective date — even though the GVP modules have not yet been formally updated.
Greater oversight. Broader scope. Higher expectations.
ICH E2D(R1) requires MAHs to move beyond traditional case processing and take full ownership of how safety data is generated, collected and governed across programmes and digital environments.
In practical terms, this means:
This update shifts the focus from reactive case handling to proactive governance of the entire safety data ecosystem.
Focus on the implications for our client in the short, medium, and long term. This includes identifying the areas that will be impacted and describing the actions required to ensure proper adaptation to the new regulatory framework.
At QbD Group, we support MAHs with:
We combine regulatory expertise with operational execution — ensuring compliance is built into your system by design.