International Council for Harmonisation (ICH)

Swissmedic is also involved in drafting international guidelines in the framework of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly known as the International Conference on Harmonisation.

Founded in 1990, the ICH aims to make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines for the assessment and market authorisation of medicinal products for human use, thereby minimising duplication during development and the authorisation process. Swissmedic represented the EFTA (European Free Trade Association) states on the ICH Steering Committee, the executive body of the ICH, as an observer until the end of June 2014 and as a member of the Steering Committee in its own right since July 2014. Following the reform of the ICH in 2015, Swissmedic became a Standing Regulatory Member of the Management Committee and an Assembly member.

Swissmedic experts also take an active part in various ICH Expert Working Groups dealing with the quality and safety of medicines, preclinical and clinical requirements, and issues regarding the constitution of authorisation dossiers.

Public Consultation

Comments can be provided in English using the feedback form specified by ICH (ICH Template) to Comments that are submitted will be forwarded to the ICH Secretariat. 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.

Supplementary information

Last modification 12.07.2024

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