Swissmedic Guidance: Submission Process for Clinical Trials with Medicinal Products

On 18 August 2025, Swissmedic published Version 2.3 of its guidance on the "Submission Process for Clinical Trials with Medicinal Products". This updated information sheet provides detailed instructions for sponsors, investigators, and applicants on how to prepare and submit applications to Swissmedic, ensuring compliance with Swiss regulations.

The Information Sheet covers essential aspects of preparing, formatting, and submitting documents, whether electronically or in paper form. Its structured approach ensures harmonization, transparency, and efficiency in the evaluation of clinical trial applications.

Key Features of the Guidance

1. FO Submission Form

• Since September 2021, only the FO submission form is accepted for submissions concerning clinical trials with medicinal products.

• This single active PDF form applies to all types of submissions:

  • New Clinical Trial Applications (CTAs)

  • Changes and reporting to approved clinical trials

  • SUSAR (Suspected Unexpected Serious Adverse Reaction) reporting

  • Temporary Authorization Projects

• The form (no scan and no digital signature) must be placed in the 00F folder with the signed signature page.

2. Folder Structure (eDok_KLV)

Swissmedic requires a strict electronic folder structure (eDok_KLV) to organize submissions. Key folders include:

• 00F: Application form (PDF, plus signed page)

• 01CL: Cover Letter

• 02EC: Ethics Committee correspondence

• 04P: Trial protocol, master protocol, and appendices

• 05S: Investigator’s Brochure (IB) and SmPC

• 06G: GMP documents

• 07Q: IMPD-related documents (simplified or full)

• 13SUSAR: SUSARs in CIOMS format

• 14FSR: Final clinical study report

• 17PIP: Paediatric Investigational Plan

• 21MEP: Medical Devices (to be in a separate folder)

This harmonized folder structure ensures consistent document handling and facilitates electronic reviews.

3. Electronic Submissions

• File names must not exceed 60 characters (including extension).

• Only PDF format is accepted, preferably digitally generated, though OCR-compliant scans are allowed.

• Maximum PDF size: 200 MB. Larger files must be split.

• Documents should include active links in their indexes for easy navigation.

Electronic submissions can be made in two ways:

1. CD submission: The eDok_KLV structure is transferred to CD and sent with a signed FO Confirmation form.

2. Swissmedic Portal submission: Sponsors can upload the eDok_KLV structure directly. Instructions are available at the Swissmedic Portal.

4. Paper Submissions

• Not mandatory but still possible for new CTAs.

• One copy of each document must be filed in an A4 2-hole ring binder (7 cm spine) with a 20-part index.

• Documents for register 21 (Medical Devices) must be provided in a separate folder.

• Empty folders or placeholder documents (e.g., “This folder is empty”) are not permitted.

Swissmedic’s updated Guidance on the Submission Process for Clinical Trials with Medicinal Products (Version 2.3, 18 August 2025) provides a robust framework for electronic and paper submissions. With clear instructions on folder structures, file formats, and submission methods, it significantly improves efficiency and compliance in clinical trial submissions.

For full details, refer to the official documents: Swissmedic Guidance on Submission Process for Clinical Trials with Medicinal Products

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