Swissmedic launches the public consultation on Guideline M11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH Guidelines), with a deadline of 26 February 2023 for comments
Public consultation on ICH Guideline M11 “Clinical electronic Structured Harmonised Protocol (CeSHarP)” launched in Switzerland
28.11.2022
Stakeholders have until 26 February 2023 to comment on the draft of Guideline M11 “Clinical electronic Structured Harmonised Protocol (CeSHarP)”. To date, no internationally adopted harmonised standard has been established for the format and content of the clinical protocol to support consistency across sponsors and for the electronic exchange of protocol information. This international guideline and template aim to support consistency in the development of structured and unstructured protocol content, and a technical specification to facilitate its electronic exchange. Comments can be sent 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: