EMA publishes Comments on ICH E2D

The European Medicines Agency (EMA) has published an overview of comments on the revised ICH E2D guidance on definitions and standards of post-authorization safety data. 

Background

The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period. The deadline for comments for Europe was 22 June 2024.

The draft guidance updates the existing E2D guidance entitled “E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting”, published in 2003. The revised document is intended to clarify the use of new or increasingly used digital platforms (e.g., social media, websites, internet forums, chat rooms, and software applications (apps) and update terminology and standards for postmarket adverse event reporting.

Comments regarding Digital Platforms

The EMA has published an overview of comments from stakeholders on the associated ICH E2D Post-approval safety data management - Scientific guideline webpage.

Several comments from stakeholders relate to the definition, requirements and handling of digital platforms:

• "A digital platform is the software and technology used..." is misleading as it is rather an interface supported by a software and technology.
• Follow-up requirements for digital platforms not under the responsibility of a MAH are not realistic/feasible.
• It's not clear in the definition what will be the requirements about software applications (apps) in case they or their components fall under the scope of definition of SaMD (software as medical device)
• To what extent are MAHs expected to pursue posts in specific private user groups or in forums requiring registration?

The comments will be forwarded to the ICH E2D Expert Working Group (EWG) for consideration as part of Step 3 of the ICH process.