Swissmedic’s Clinical Trial Guidance Suite: Everything Sponsors Need to Know
- Sharan Murugan
- 11 hours ago
- 2 min read
On June 2, 2025, Swissmedic published a harmonised suite of guidance documents to standardise, streamline, and digitalise the clinical trial application and amendment process for medicinal products in Switzerland. These documents, targeted at sponsors, CROs, and regulatory professionals, address:
New CTA dossier submission expectations
eDok_KLV folder structure compliance
Electronic and paper-based submission workflows
Amendment and safety reporting during ongoing trials
Swissmedic mandates using the FO Submission Form for all clinical trial submissions—including new applications, amendments, safety reporting (SUSARs), and temporary authorisations. Only this active PDF form is accepted; scanned or digitally signed versions will be rejected.
Submissions must follow the eDok_KLV folder structure, available via Swissmedic’s portal. There are two main submission methods:
Via CD by mail: Accompanied by a signed paper form.
Via Swissmedic Portal: Fully digital uploads through secure login.
This guideline is the central reference for compiling a compliant CTA. It outlines required documents, formatting, cross-referencing expectations, and applicable folder mapping.
Key dossier sections include:
Trial Protocol and Investigator’s Brochure
Safety Documentation (SmPC or RSI)
GMP and Quality Documents for IMPs and AxMPs
Label Samples, Pharmacy Manual, and Radiopharmaceuticals
Nonclinical and PK/PD Reports
Cover Letters, EC Correspondence, and Foreign RA decisions
Parallel submissions (e.g., for confidential GMP/Quality documents) are accepted via split dossier routes between sponsors and third-party providers.
Submission must follow ClinO Art. 33 timelines:
30 days for standard review
60 days for First-in-Human (FIH) or complex IMP manufacturing
Swissmedic's digital standard, the eDok_KLV folder structure, ensures uniformity in CTA file submissions. This guideline clarifies:
Proper folder usage for over 20 categories (protocol, SmPC, GMP, etc.)
How to name files and avoid exceeding path limits (180 characters max)
Restrictions on file types (PDF only) and size (≤200 MB per file)
How to split large documents or submit working instructions
All irrelevant folders must be deleted before submission. Empty folders or placeholder documents (e.g., “this folder is empty”) are strictly prohibited.
Once a trial is authorised, any substantial modification must follow the amendment process outlined in this guidance. Submissions must include:
Updated documents (clean + track change)
FO Submission Form with the correct “Change” or “Reporting” type
Summary tables explaining the changes and their regulatory impact
Changes include:
Protocol modifications (e.g., IMP use, safety)
Quality updates to PQD, labels, GMP documentation
Investigator Brochure or SmPC updates (safety relevance)
Administrative changes (sponsor name, Swiss rep, etc.)
Trial status updates (start, completion, interruptions)
Swissmedic must approve changes before implementation, except in cases involving urgent safety measures.
These four harmonised Swissmedic guidance documents set a new standard for how clinical trials with medicinal products should be documented and submitted in Switzerland. Access All Four Swissmedic Guidance Documents
Also see the other recent guidances that were published on 1 June 2025, accessible via the official Swissmedic – Updated Documents: June 2025 page.