The revised ICH E2D(R1) guideline came into effect in the EU on 18 March 2026. It updates the original 2003 guidance on the definitions and standards for managing and reporting individual case safety reports (ICSRs) in the post-approval phase, together with good case management practice. The revision reflects the significant evolution of pharmacovigilance over the past two decades and addresses the growing use of digital and real-world data sources in safety surveillance.
What’s changing
One of the most significant changes is the expanded scope of safety data sources that marketing authorisation holders are expected to consider. The revised guideline provides specific guidance on the management of safety information obtained through digital platforms, social media, market research programmes, patient support programmes (PSPs) and other organised data collection systems.
The guideline introduces updated definitions and terminology to better reflect current pharmacovigilance practice, including new or revised definitions for digital platforms, patient support programmes, market research programmes and organised data collection systems. It also provides greater clarity on when adverse events obtained through these channels may qualify as reportable ICSRs and how they should be managed within a company’s pharmacovigilance system.
In addition, ICH E2D(R1) includes new guidance on safety data originating from non-interventional studies, both those involving primary data collection and those based on the secondary use of existing data sources such as registries or databases. The revised guideline also updates expectations regarding case validation, data quality, duplicate detection and oversight of third parties involved in safety data collection and management.
What to do now
A transition period runs until 18 September 2026, giving you time to align your pharmacovigilance systems with the new requirements. Use it to review how your organisation captures and processes safety information, pay particular attention to patient support programmes, market research activities, organised data collection systems, digital platforms and non-interventional studies, and update your procedures and systems accordingly.
This is also a good opportunity to review pharmacovigilance agreements, standard operating procedures, case-processing workflows and training programmes to ensure they remain aligned with the revised guideline.
In support of implementation, the EU has published an implementation strategy for marketing authorisation holders, national competent authorities and inspectors.
How MPCA can help
We can help you map the changes to your procedures and update your pharmacovigilance system in time. See our pharmacovigilance service page, or read the guideline on the EMA website.
This article is for general information and reflects the situation at the time of writing. Always consult the official ICH and EMA publications for binding requirements.