Here you will find useful information that will guide you through the Clinical Trial Application (CTA) process at Swissmedic. All Swissmedic requirements for a complete CTA dossier are listed in the guidelines published below.
Since 01.01. 2014, CTAs for categories B and C clinical trials can be made in parallel to Swissmedic and to the lead Ethics Committee (Category A clinical trials of therapeutic products are exempted from the requirement for authorisation from Swissmedic, art. 30 ClinO, RS 810.305). Both authorities review their respective dossier and issue separate approvals. The trial cannot start before both approvals have been obtained (art. 45 HRA, SR 812.21; art. 54 TPA, SR 812.21).
Guidelines for CTA dossiers submitted
Clinical Trial Application dossier Guideline
Guidance on Pharmaceutical Quality Dossier
List of Countries with recognised GMP control systems
Interpretation guide: Obligations of representatives of foreign sponsors