What is it? Why is it important?

For studies with an Investigational Medicinal Product (IMP), Swissmedic acknowledges the receipt of an application dossier within 7 days.

Swissmedic makes a formal evaluation whether the application dossier is complete, or if documents are:

  • Missing, and/or
  • Incomplete, and/or
  • Not correctly filed

In the event of an incomplete dossiers the SP-INV is asked to update the dossier within a given deadline.

Swissmedic provides an answer whether the application has been approved:

  • Within 30 days
  • Or between 30 and 60 days if the product:
    • Has never been tested in humans (first in man, phase I studies); or
    • Is manufactured based on new production procedures

Once submitted to Swissmedic the study is given an individualised reference number. This number is included in all future Swissmedic correspondence.

More

If prior to approval, Swissmedic still has open issues regarding the application dossier, they will forward a preliminary decision letter listing what documents must still be:

  • Submitted and/or
  • Changed / adapted

As a consequence, the application time clock is stopped until all requested documents are forwarded and/or all requested changes are made.

A rejected study by Swissmedic cannot be re-submitted. Any required adaptations would result in a new study and totally new submission.

Approval timelines for studies using an IMP and MD in combination (in vitro), depends on the conformity of each product (e.g. consult Swissmedic tables regarding potential combination).

What do I need to do?

If prior to approval, Swissmedic requires additional information or changes to the application dossier, submit:

  • A cover letter
  • An updated CTA, if required
  • Additionally required documents and/or information
  • Required modifications (e.g. to submitted documents)

The study can only start after Swissmedic, EC, and if applicable FOPH have approved the study.

After approval the SP-INV ensures that:

  • The Swissmedic reference number is included in all future correspondence
  • A robust document tracking system is in place (e.g. ensures that only Swissmedic approved documents are used in the study)
  • Modifications made to approved documents are re-submitted for approval prior to implementation (e.g. including EC approval)

File all Swissmedic correspondence including the official Swissmedic approval document in the TMF, and if applicable in the ISF of participating study sites.

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
  • 812.21 TPA

ClinO – see in particular articles

  • Art. 23 Coordination in authorisation procedures
  • Art. 30 Exemption from authorisation
  • Art. 32 Review areas
  • Art. 33 Procedure and deadlines

TPA – see in particular article

  • Art. 54 Mandatory authorisation
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTA – Clinical Trial Application
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • FOPH – Federal Office of Public Health
  • IMP – Investigational Medicinal Product
  • ISF – Investigator Site File
  • MD – Medical Device
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
  • TPA – Therapeutic Products Act
Development ↦ Ethics and Laws ↦ Swissmedic Application ↦ Approval Medicinal Products
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 ↦ Approval Medicinal Products

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