EMA Guidance: Implementation of ICH E2D(R1) for Post-Approval Safety Reporting and the EU Network Data & AI Strategy
- Sharan Murugan
- 2 hours ago
- 4 min read
Regulatory authorities across the European Union continue to strengthen pharmacovigilance systems and data-driven regulatory decision-making. Two important EMA documents highlight these developments: the EU implementation strategy for the ICH E2D(R1) guideline on post-approval safety data and the Network Data Steering Group (NDSG) Workplan 2026–2028 on data and artificial intelligence in medicines regulation.
The Network Data Steering Group (NDSG) was established by the European medicines regulatory network to maximise the value of data in medicines regulation. The group focuses on improving data interoperability, evidence generation, and the use of artificial intelligence to support regulatory decision-making.
The vision guiding this work is “Trusted medicines by unlocking the value of data.” The work plan, adopted in February 2026, outlines activities for the period 2026–2028 and contributes to the implementation of the broader European Medicines Agencies Network strategy to 2028.
Key Workstreams of the Data and AI Strategy
The NDSG workplan is structured around six major workstreams designed to strengthen data use in medicines regulation.
Strategy and Governance
The workplan also aligns with initiatives such as the European Health Data Space (EHDS) and other European data-sharing frameworks.
Data Analytics
Data analytics activities aim to strengthen evidence generation for regulatory decisions by analysing diverse types of data, including:
Real-world data and real-world evidence
Clinical study data
Non-clinical data
EudraVigilance pharmacovigilance data
Genomic data
The workplan also includes activities related to innovative methodologies such as modelling and simulation, biostatistics, and pharmacoepidemiology.
One important initiative in this area is DARWIN EU®, a federated network that enables access to real-world data to support regulatory evaluations and scientific assessments.
Artificial Intelligence
Artificial intelligence is becoming an increasingly important tool in regulatory science. The workplan outlines activities aimed at supporting the safe and responsible use of AI across the medicines lifecycle.
Key activities include the development of AI guidance, support for AI-related regulatory evaluation, and the deployment of AI tools within the regulatory network. The strategy also emphasises compliance with the EU AI Act and data protection regulations, as well as responsible AI governance.
Data Interoperability
Improving interoperability between regulatory data systems is another key objective of the workplan.
Activities include cataloguing regulatory data assets, improving data quality frameworks, and promoting common data standards across regulatory systems. The Product Management System (PMS) has been identified as a central source of medicinal product master data supporting EU-wide regulatory processes.
Stakeholder Engagement and Change Management
To support the transition toward data-driven regulation, the workplan emphasises stakeholder engagement and training. This includes knowledge-sharing initiatives, workshops, and communication with industry, healthcare organisations, and other stakeholders.
Training programs will also be developed to strengthen expertise in areas such as data science, pharmacoepidemiology, artificial intelligence, and regulatory data analysis.
Guidance and International Initiatives
The final workstream focuses on the development of methodological guidance and collaboration with international partners.
The EMA network will contribute to the development and implementation of international guidelines through organisations such as the International Council for Harmonisation (ICH). Activities also include supporting global initiatives related to real-world evidence, clinical trial data standards, and regulatory science collaboration.
The European Medicines Agency (EMA) issued an implementation strategy to support the practical application of the ICH E2D(R1) guideline, which addresses post-approval safety data definitions and standards for managing and reporting individual case safety reports (ICSRs) in the European Union.
This guidance is intended for Marketing Authorisation Holders (MAHs), national competent authorities, and inspectors, providing guidance on how to apply the revised guideline in the EU pharmacovigilance framework. The revised ICH E2D(R1) guideline was adopted in September 2025 and will officially come into effect in the EU on 18 March 2026. To support implementation, an additional transition period will be allowed until 18 September 2026 for MAHs to update their processes and systems accordingly.
The revised guideline introduces updated definitions and standards for handling post-approval safety information and ensures alignment with current pharmacovigilance practices. In the EU regulatory framework, the implementation of ICH E2D(R1) will be integrated into Good Pharmacovigilance Practice (GVP) Module VI, which provides regional guidance for managing safety reports. Until the revised GVP module is implemented, the updated definitions and principles from the ICH guideline should be followed according to the EU implementation strategy.
It is also noted that the implementation of the ICH E2D(R1) guideline is independent from changes related to the EudraVigilance system data element updates. These updates will be introduced separately through the system change management process.
The revised guideline introduces a clearer definition of Patient Support Programs (PSPs). PSPs are organised systems initiated by a marketing authorisation holder in which patients enrol to receive support related to the use of a medicinal product or management of their medical condition. These programs include two-way communication between the MAH (or its representative) and patients or healthcare professionals.
The revised guidance also clarifies how adverse drug reactions (ADRs) arising from these activities should be handled. ADRs originating from PSPs should be treated as solicited reports, whereas ADRs from one-way interaction activities should be treated as spontaneous reports. For new programs, MAHs are expected to implement the revised PSP definition and reporting approach by 18 September 2026.
The guideline also introduces the concept of Organised Data Collection Systems (ODCS). An ODCS refers to any planned activity that gathers data related to a medicinal product or disease area in a structured manner to allow systematic review. Examples include clinical trials, non-interventional studies, patient support programs, market research programs, and certain digital data-collection initiatives.
For more details, see the sources below:
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