Updated ICH E2D(R1) on post-approval safety data comes into effect in the EU

The updated ICH E2D(R1), which provides guidance on management and reporting of post-authorisation individual case safety reports, came into effect on 18th March 2026.

This is the first revision of ICH E2D(R1) in over 20 years.

The purpose of the update is to clarify how post-authorisation safety data that is derived from solicited sources such as social media, market research programs, patient support programs, and others, which may differ in their characteristics and contributions to the quality of post-approval safety information, should be managed. The updated Guideline also provides updates on definitions, standards, and regulatory guidance for the management and reporting of post-approval drug safety information intended to support appropriate safety surveillance of medicinal products based on the current practices and needs.

The EMA has prepared guidance outlining the changes and how they are to be applied.

A six month transition period permitting marketing authorisation holders to update their processes to reflect new obligations has been established. However, from 18th September 2026 the definitions and guidance provided in the ICH E2D(R1) Guideline will become applicable and users will be required to apply these.