Swissmedic launches the public consultation on Guideline E2D(R1) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines), with a deadline of 22 June 2024 for comments.
Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
04.03.2024
Stakeholders in Switzerland have until 22 June 2024 to comment on the draft of Guideline E2D(R1) “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports”. Since the original ICH E2D guideline was agreed in 2003, new sources of post-approval safety information have emerged or are applied more frequently (e.g. social media, market research programmes, patient support and assistance programmes) which vary in terms of their characteristics and their contribution to the quality of post-approval safety information. The definitions and regulatory guidance in ICH E2D are no longer sufficient to provide guidance on current practices and needs. Therefore, the original considerations and standards need to be carefully revisited in order to adapt the existing concepts, principles and definitions of the ICH E2D guideline and to support appropriate safety surveillance and actions in consideration of the new sources of safety information.
Comments can be provided using the feedback form specified by ICH to networking@swissmedic.ch. Stakeholders will receive confirmation of receipt of their comments but no feedback on the individual comments. After completion of the public consultation phase, the comments submitted will be discussed in the responsible ICH working groups and taken into account where appropriate.
Links to the guideline and feedback form can be found on the following page: