EMA publishes Comments on ICH E2D
Recommendation
Tuesday, 29 October 2024 9 .00 - 17.00 h
GMP / GVP Interfaces and Challenges
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The draft guidance updates the existing E2D guidance entitled “E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting”, published in 2003.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.
Related GMP News
01.10.2024GVP Updates
03.09.2024EMA publishes ICH Reflection Paper on RWD / RWE
03.09.2024Real-World Data: FDA's final Guidance on the Use of eHRs in Clinical Studies
03.09.2024New USP Chapter for Food Supplements
20.06.2024EMA's Reflection Paper on the Use of Real-World Data in Non-Interventional Studies