Earlier today (23-November-2022) Swissmedic released two updated guidelines "Guideline Amendments Clinical Trials" and "Clinical Trial Application Dossier".
This guideline gives detailed Instructions for submitting changes and for reporting during the course of a clinical trial. These instructions concern changes and reporting related exclusively to clinical trials of Category B and C.
All information on the technical requirements for the submission of applications for clinical trials for medicinal products is described in "Applications for clinical trials for medicinal products".
A document related to several clinical trials can be submitted using a single submission form. However, a separate form must be used for each sponsor representative. The clinical trial(s) must be clearly identified with their Swissmedic reference numbers.
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In this guideline, requirements for CTA dossiers relating to clinical trials with medicinal products are clarified. The FO Submission Form must be used for the submission of a new Clinical Trial Application. This form contains all 5 possibilities of submissions on clinical trials
1) New CTA,
2) submission to an authorised clinical trial,
3) answer to condition,
4) answer to formal deficiency and
5) answer to further information request.
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