Stakeholders in Switzerland have until 28 February 2025 to comment on the draft of Guideline E6(R3) Annex 2 “Good Clinical Practice (GCP)”.
In the two decades since ICH E6 was first drafted, clinical trials have become more complex with respect to trial design, use of technology, quantity of data collected and involvement of central testing facilities or other service providers. ICH E6(R2) was developed with multiple addenda to address the emerging use of electronic data sources and risk management processes. However, since the development of E6(R2), clinical trials have continued to evolve with new designs and technological innovations. The scope of E6(R3) is to expand, modify, and reorganise all appropriate sections to provide scientific and ethical guidance that enables a diversity of approaches that are relevant and adaptable to the variety of clinical trial designs and innovative technologies. When complete, E6(R3) will be composed of an overarching principles and objectives document, Annex 1 (interventional clinical trials) and Annex 2 (additional considerations for non-traditional interventional clinical trials). The proposed development of Annex 2 will include additional considerations on how GCP principles may be applied across a variety of trial designs and data sources, where applicable. These additional considerations are based on the foundation established in Annex 1. Annex 2 should be read and implemented with E6(R3) principles and Annex 1.
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: