30.10.2025
Update of the position paper of Swissmedic and swissethics on decentralised clinical trials (DCTs) of medicinal products
Update regarding the legal basis for shipping investigational medicinal products (IMPs), (new version 3.3).
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Previous publications
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.
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).
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.
21.08.2023
Clinical trials on medicinal products - Pandemic by SARS-CoV-2
Recommendations Swissmedic / swissethics for the treatment of patients