From 18 March 2026, the revised ICH E2D(R1) guideline will reshape how Marketing Authorisation Holders manage structured safety data. The update introduces clearer expectations for ODCS, PSPs, MRPs and company-managed digital platforms, shifting regulatory focus toward stronger governance, vendor oversight and active monitoring of digital environments.
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.
What's new?
1. ODCS is now clearly defined and central to compliance
Structured activities such as PSPs, MRPs, registries, and certain digital monitoring initiatives fall explicitly within the ODCS concept. This affects case classification (e.g., solicited vs spontaneous), documentation, and reporting workflows.
2. Digital platforms under MAH responsibility require active screening
Company-managed websites, apps, and social media channels must be regularly screened at a justified frequency to ensure timely AE reporting.
3. Stronger governance expectations for PSPs & MRPs
Regulators expect:
- Clear documentation of programme set-up
- Defined roles and responsibilities
- Contractual safety reporting clauses with vendors
- Demonstrable oversight and quality control
4. Increased focus on system robustness
Inspectors will assess not only individual case handling, but the maturity of your PV governance model, vendor oversight and digital monitoring strategy.
What does this mean to you?
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:
✔ Clear identification and classification of all ODCS activities
✔ Active and justified monitoring of company-managed digital platforms
✔ Robust documentation of PSPs, MRPs and structured data collection initiatives
✔ Stronger vendor oversight with explicit safety reporting obligations
✔ Demonstrable inspection readiness at system level
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.
How can QbD Group assist you?
At QbD Group, we support MAHs with:
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E2D(R1) readiness assessments and risk-based remediation plans
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ODCS governance model design and documentation updates
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Vendor oversight optimisation and contractual compliance
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Digital media monitoring services, including structured screening of company-managed digital channels in line with regulatory expectations
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Implementation support, training and inspection preparedness
We combine regulatory expertise with operational execution — ensuring compliance is built into your system by design.
关于作者
Former QPPV · Division Head Vigilance & Country Manager Spain
Almudena leads pharmacovigilance strategy and operations at QbD Group as Division Head of Vigilance and Country Manager for Spain, helping pharma and biotech companies build robust drug safety systems.
Navigate Regulatory Complexity with Confidence
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