What is it? Why is it important?

The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) studies with medicinal products (MP).

In these studies an Investigational Medicinal Product (IMP) is defined as:

  • A pharmaceutical form of an active ingredient or placebo being tested or used as a reference
  • A product:
    • With marketing authorisation used or assembled in a way different from the approved form (e.g. formulated, packaged)
    • Used for an unapproved indication (e.g. for the treatment of alternative diseases, a change in administration mode)
    • Used to gain further information about an approved use

Based on the study set-up and intervention, risk categories A, B, or C apply (e.g. with A having the lowest and C the highest risk).

More

Category A: the IMP is authorised in Switzerland and its use:

  • Is in accordance with the prescribing information
  • Is in an indication or dosage different from that specified in the prescribing information, but in accordance with the following criteria:
    • the indication is within the same ICD disease group
    • the disease in question is self-limiting and the dosage of the medicinal product is lower than that specified in the prescribing information; or
  • Is recognised as standard in guidelines prepared in accordance with internationally accepted quality criteria

Category B: the IMP is:

  • Authorised in Switzerland; and
  • Not used as specified in category A

Category C: the IMP is not authorised in Switzerland.

In justified cases (if possible or necessary), and under consideration of the participants’ safety and health, the study may be assigned to a different risk category.

What do I need to do?

For studies with IMP, you are required to know and comply with the requirements defined in the ClinO ordinance:

  • Familiarise yourself with the organisation of the various chapters and sections
  • Focus on the articles that are relevant to your study

Based on the risk category, submit your application dossier to:

  • EC who grants authorisation of category A, B, and C studies and provides a reply within:
    • 30 days for monocentric studies
    • 45 days for multi-centre studies
  • Swissmedic who grants authorisation of category B and C studies and provides a reply within:
    • 30 days after acknowledgement of receipt of the complete application dossier
    • A potential additional 30 days for first in human studies, or for IMPs manufactured in a new process
    • Category A studies are exempt from Swissmedic authorisation

Swissmedic and EC submissions can be made in parallel.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Templates and checklists
    • Study protocols / Clinical trials

References

ICH GCP E6(R2) – see in particular article

  • Art. 1.33 Investigational product definition

KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation

Swiss Law

FEDLEX – law is available online under number

  • 810.305 ClinO

ClinO – see in particular articles

  • Art.19 Categorisation of IMP studies
  • Art. 26 Procedures and deadlines EC
  • Art. 27 Procedures and deadlines EC in multi-centre clinical trials
  • Art. 33 Procedures and deadlines Swissmedic
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ICD – International
  • KOFAM – Coordination portal for human research
  • Classification of Diseases
  • IMP – Investigational Medicinal Product
  • MP – Medicinal Product
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ 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): Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Medicinal Products

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