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.

Draft ICH Guidelines 
Status for consultation Deadline for comments
Guideline Q13
Continuous Manufacturing of Drug Substances and Drug Products
30 November 2021
Guideline S12
Non-clinical Biodistribution Considerations for Gene Therapy Products
30 September 2021
Guideline S1B(R1)
Rodent Carcinogenicity Studies for Human Pharmaceuticals
Closed 31 August 2021
Guideline Q9(R1)
Quality Risk Management
Closed 15 March 2022
Guideline Q2(R2)/Q14
Analytical Procedure Development and Revision of Q2(R1) Analytical Validation
Closed 31 July 2022
E11A Paediatric Extrapolation
Closed 13 September 2022
M12 Drug Interaction Studies
Closed 21 November 2022
Q5A(R2) Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
Closed 10 February
M11 Clinical electronic Structured Harmonised Protocol (CeSHarP
Closed 26 February
M13 Bioequivalence for Immediate-Release Solid Oral Dosage Forms
Closed 26 May 2023
E6(Rj3) Good Clinical Practice (GCP)
Closed 26 September 2023

Supplementary information

Last modification 13.11.2023

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