What is it? Why is it important?

The required content of a Clinical Trial Application (CTA) dossier to Swissmedic depends on the risk-category of study (e.g. either B or C) and the product under investigation, such as:

  • An Investigational Medicinal Product (IMP)
  • An Investigational Medical Device (IMD)
  • An IMP and (I)MD combination product
  • A product (e.g. IMP or IMD) emitting ionising radiation


As a minimum, the SP-INV submits the following documents:

  • A submission form corresponding to the type of product under investigation
  • A cover letter
  • The Ethics Committee (EC) correspondence and/or decision(s) regarding the study
  • If applicable, the decision from any Foreign Competent Authorities
  • The study protocol
  • The Investigator Brochure (IB) for IMP/IMD or the MP product information or the MD instructions for use


Incomplete applications are rejected by Swissmedic.


Examples of documents requested in an IMP study:

  • Safety documents (e.g. the summary of Product Characteristics (SmPC) for MPs with marketing authorisations in Switzerland)
  • Good Manufacturing Procedures (GMP) documents (e.g. proof of GMP compliance)
  • Quality documents (e.g. IMPD / PQD describe the manufacturing process and control)
  • The IMP product label to be used in the study
  • The pharmacy manual
  • Toxicology report(s)


Examples of documents requested in a IMD study:

  • The Case report Form (CRF)
  • The Patient Information sheet (PIS) and Informed Consent Form (ICF)
  • Contracts
  • Instructions for Use (IFU)
  • List of applicable standards
  • CE marking information
  • Manufacturer statement
  • Confirmation that documentation is kept available during the mandatory storage period after the end of study
  • Proof of insurance


Example of documents requested for a IMD emitting radiations is:

  • Ionising radiation information

What do I need to do?

As a SP-INV, compile your submission dossier:

  • Familiarise yourself with the guidelines provided on the Swissmedic homepage
  • Collect all required documents and ensure they are up to date and identifiable (e.g. document identification)
  • Prepare documents according to submission requirements:
    • IMD studies are submitted on eMessage portal (purely electronic)
    • ClinO studies without a Medical Device (MD) are submitted by post. Choose if you want to submit a full paper dossier or a paperless dossier. Do not include the Confidentiality Disclosure Agreement (CDA)


For IMP and MD combinations and other products which are borderline, Switzerland takes into account the European delimitation criteria between medicinal products and medical devices.

For a combination of Medicinal Devices (MDs) and other products which are borderline (e.g. a transplant product that includes a medical device component), Switzerland takes into account the European delimitation criteria between medicinal products and medical devices.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissmedic – see in particular

  • Human medicine / Clinical trials / Clinical trials on medicinal products
  • Medical devices / Clinical trials / Authorisation procedure
  • Services & Lists / eGOV services
  • Services & Lists / submissions

Swiss Law

ClinO – see in particular annex

  • Annex 4 Submission document list

ClinO-MD – see in particular annex

  • Annex 1 Submission document list
  • CDA – Confidentiality Disclosure Agreement
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CRF – Case Report Form
  • CTA – Clinical Trial Application
  • CTU – Clinical Trials Unit
  • EC – Ethic Committee
  • GMP – Good Manufacturing Procedures
  • IB – Investigator Brochure
  • ICF –Informed Consent Form
  • IFU – Instructions for Use
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • MP – Medical Product
  • IMPD – Investigational Medicinal Product Dossier
  • MD – Medicinal Device
  • PIS – Patient Information Sheet
  • PQD – Pharmaceutical Quality Documentation
  • SmPC – Summary of Product Characteristics
  • SP-INV – Sponsor Investigator
Development ↦ Ethics and Laws ↦ Swissmedic Application ↦ Application Dossier

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Ethics and Laws ↦ Swissmedic Application ↦ Application Dossier

Please note: the Easy-GCS tool is currently under construction.