What is it? Why is it important?

The content of a Clinical Trial Application (CTA) dossier to Swissmedic varies based on study type. Studies can include an investigation with:

  • An Investigational Medicinal Product (IMP)
  • An Investigational Medical Device (IMD)
  • An IMP and (I)MD combination product
  • A product emitting ionising radiations

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 EC correspondence and/or decision(s)
  • If applicable, the decision from any Foreign Competent Authorities
  • The study protocol
  • The Investigator Brochure (IB) for IMP/IMD, and based on study the MP product information or the MD instructions for use

Incomplete applications are rejected by Swissmedic.

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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 version, date of release)
  • Prepare documents according to submission requirements:
    • IMD studies are submitted on eMessage portal (purely electronic)
    • ClinO studies without MD are submitted by post. Choose if you want to submit a full paper dossier or a paperless dossier. Do not include the CDA

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ClinO studies without in vitro diagnostic MDs are submitted by post in both paper and electronic formats:

Option: Full paper submission:
  • Prepare a binder and include a copy of each document (e.g. filed with number index).
  • Structure registers based on the “Instructions for filling the eDoc folder structure”.
  • Burn a CD with the same structure
  • Submit binders and CD by postOption: paperless submission:
  • Print and sign the paper form “Confirmation electronic submission”
  • Burn a CD with documents filed based on “Instructions for filling the eDoc folder structure”
  • Submit form and CD by post

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

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD

ClinO – see in particular annex

  • Annex 4 Submission document list

ClinO-MD – see in particular annex

  • Annex 1 Submission document list
Abbreviations
  • 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
  • FEDLEX – Publication Platform for Federal Laws
  • 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 Prodect
  • 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
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

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