The original ICH E2D Guideline has been published in May 2003 to establish an internationally standardized procedure to improve the quality of post-approval drug safety information and to harmonise the way of gathering and reporting it. The guideline provides guidance on definitions and standards for post-approval safety information management and reporting, as well as on good case management practices.
Since its original publication new sources of post-approval safety information have emerged or are more frequently used (e.g. digital platforms, social media, mobile health technologies, market research programs, patient support programs, non-interventional studies, literature), which vary in characteristics and contributions to the quality of the safety data received.
The revised Guideline ICH E2D(R1) provides updates on the definitions, standards, and regulatory guidance for the management and reporting of post-approval drug safety information with the aim to support appropriate safety surveillance of medicinal products based on the current practices and needs. New guidance is also included focusing on the management of safety data from non-interventional studies with primary data collection, as well as from non-interventional studies with secondary use of data. Where applicable, the guideline notes where local and regional requirements may vary and, as such, marketing authorization holders should refer to the relevant regional and local regulatory authority’s requirements.
A presentation highlighting the significant changes to the original ICH E2D Guideline from 2003 is available for support; Stakeholders should refer to the complete E2D(R1) Guideline to obtain a full overview on all the changes and updates.
Some training material has been developed with practical examples illustrating the concepts used in ICH E2D(R1) and the updates to ICH E2B(R3) coding practices.
An information paper has also been published to explain the alignment of ICH E2B(R3) specifications with the revised ICH E2D guideline. It provides information on the updates to the two existing ICH E2B(R3) data-elements: “C.1.3 Type of Report” and “C.5.4 Study Type Where Reaction(s) / Event(s) Were Observed”. ICH Code List 8 (CL8) has been updated to accommodate the new values in data element C.5.4 that should allow to better classify solicited reports originating from patient support programs, market research programs, or from organized data collection systems with source data from digital platforms. The implementation in the EU of the new values will be addressed at a later stage through the change management process for the EudraVigilance system.
Implementation in the EU of the ICH E2D(R1) guideline
The ICH E2D(R1) guideline comes officially into effect in the EU on 18 March 2026. An implementation strategy document has been developed to support the practical implementation of the Guideline in the EU. It includes guidance for Marketing Authorisation Holders (MAHs), as well as for National Competent Authorities and Inspectors on the transition to the new definition for Patient Support Program and to the new required detailed documentations for Organised Data Collection Systems not conducted according to a protocol.
Keywords: Adverse event (AE), adverse drug reaction (ADR), spontaneous reports, solicited reports, organised data collection system (ODCS), digital platform, social media, mobile health technologies, patient support program (PSP), market research program (MRP), non-interventional studies with primary data collection, non-interventional studies with secondary use of data, lack of efficacy, overdose, abuse, misuse, medication error, occupational exposure, exposure during pregnancy and breastfeeding, post-approval drug safety information, individual case safety report (ICSR), duplicate management, follow-up information, reporting timeframes.