Swissmedic Guidance: Clinical Trials with Medicinal Products, Submission Process and FAQs

Sharan Murugan
2 hours ago
2 min read

Clinical trials are the cornerstone of developing safe and effective medicines. In Switzerland, the regulatory authority Swissmedic oversees all clinical trials with medicinal products under a robust framework that aligns with EU and international standards.

Swissmedic recently updated two key documents:

Together, these provide sponsors, investigators, and stakeholders with clear instructions on regulatory submissions, legal responsibilities, safety reporting, and practical aspects of trial conduct.

Swissmedic’s Clinical Trials Division is responsible for evaluating trial applications, safety, quality, and conducting Good Clinical Practice (GCP) inspections. Combined studies involving medicinal products and medical devices are jointly reviewed with the Medical Devices Division.

Submission Process

FO Submission Form

Since September 2021, only the FO submission form has been accepted for clinical trial submissions. This active PDF form must be used for all applications, whether they are for new trials, modifications, reporting of suspected unexpected serious adverse reactions (SUSARs), or temporary authorisation projects.

Folder Structure (eDok_KLV)

Swissmedic requires that all documents be arranged in a very specific electronic folder structure called eDok_KLV. Each folder corresponds to a category of documents, such as cover letters, trial protocols, investigator’s brochures, GMP certificates, labels, annual safety reports, SUSAR reports, and final study reports.

There are three main ways to submit a clinical trial dossier to Swissmedic:

By mail on CD: The eDok_KLV structure is transferred to a CD and submitted along with a signed paper confirmation form.
Through the Swissmedic Portal: The folder structure is uploaded electronically.
In paper form: This option is not mandatory, but if chosen, all documents must be printed, filed in binders, and indexed carefully

Clinical trials in Switzerland are classified into three categories:

Category A: Trials involving medicines that are already authorised in Switzerland, used strictly according to their approved label (SmPC).
Category B: Trials with medicines that are authorised but being used outside their approved conditions, or with low-risk modifications. Placebo-controlled studies with authorised comparators also fall here.
Category C: Trials with unauthorised medicines or with higher-risk modifications, such as first-in-human studies with novel compounds.

Sponsors are responsible for initially classifying their trials,If a trial is misclassified, it must be resubmitted as a substantial amendment. All investigational products must be manufactured and tested in compliance with Good Manufacturing Practice (GMP) standards.

Sponsors located outside Switzerland must appoint a Swiss representative. This representative acts as the local contact person for liability issues and correspondence. Switzerland also requires that a Responsible Person (RP), equivalent to the EU Qualified Person (QP), oversee GMP and GDP compliance for investigational medicines. For new investigational products, preclinical safety studies must comply with Good Laboratory Practice (GLP) standards.

timately, these requirements protect trial participants, strengthen the credibility of clinical data, and support Switzerland’s role as a trusted hub for international clinical research.

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