Swissmedic - Swiss Agency for Therapeutic Products

09/01/2025 | News release | Distributed by Public on 09/01/2025 01:32

Position paper by Swissmedic and swissethics on clinical trials with medicinal products examined for the first time in humans

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01.09.2025

Position paper by Swissmedic and swissethics on clinical trials with medicinal products examined for the first time in humans

During clinical trials with medicinal products in early development phases (i.e. first in human application, early phase I studies) new investigational medicinal products are examined for the first time in humans. Initial insights are hereby collected on their tolerability and safety. To ensure the protection of the trial participants to the greatest extent possible, special aspects have to be considered during the planning and conduct of such clinical trials by the sponsors and participating clinical trial centres. Swissmedic and swissethics have summarised these aspects in a position paper.

General aspects to consider for FIH/early phase I clinical trials with medicinal products(PDF, 166 kB, 01.09.2025)

Previous publications

15.08.2025

Update of the position paper of Swissmedic and swissethics on decentralised clinical trials (DCTs) of medicinal products

The references in the position paper have been updated according to ICH-GCP E6 (R3) (new version 3.2).

Position Paper - Decentralised clinical trials (DCTs) with medicinal products in Switzerland(PDF, 1 MB, 15.08.2025)

10.02.2025

Update of the position paper of Swissmedic and swissethics on decentralised clinical trials (DCTs) of medicinal products

The position paper has been comprehensively amended and updated (new version 3.1). New features include a comparison of Switzerland with European member states in terms of the feasibility of various DCT elements.

Position Paper - Decentralised clinical trials (DCTs) with medicinal products in Switzerland(PDF, 1 MB, 15.08.2025)

21.08.2023

Clinical trials on medicinal products - Pandemic by SARS-CoV-2

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