What is it? Why is it important?

The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) studies using standardised transplant products.


Standardized transplants are products:

  • From human or animal origin
  • Made from organs, tissues or cells
  • Whose manufacturing process can be standardized


Study set-up and type will decide the risk-category of the study (e.g. risk-categories A, B, or C apply, with A having the lowest and C the highest risk). As applicable, the same provisions and risk categorisations as defined for Medicinal Product studies apply.


Category A: the transplant product 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 transplant product is:

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


Category C: the transplant product 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?

As a SP-INV planning a study with transplant products, 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 risk-category of your study, submit your application dossier to:

  • The Ethics Committee (EC, application dossier) who grants authorisation of risk-category A, B, and C studies and provides a first reply within:
    • 30 days, for monocentric studies
    • 45 days, for multi-centre studies
  • The Swissmedic (e.g. application dossier) who grants authorisation of risk-category B and C studies and provides a reply within:
    • 30 days
    • A potential additional 30 days for first in human studies, or for transplant products manufactured in a new process
    • Risk-category A studies are exempt from Swissmedic authorisation


A Swissmedic submission and an EC submission must be done in parallel.

Where can I get help?

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


KOFAM: Coordination portal for human research – see in particular

  • Online wizard for risk categorisation

Swiss Law

ClinO – see in particular articles

  • Art. 21 Categorisation of studies of transplant products
  • Art. 26 Procedures and deadlines EC
  • Art. 27 Procedures and deadlines EC in multicentre clinical trials
  • Art. 33 Procedures and deadlines Swissmedic
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • ICD – International Classification of Diseases
  • KOFAM – Coordination portal for human research
  • HRA – Human Research Act
  • MP – Medicinal Product
Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Standardized Transplant Products

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): Basic ↦ Ethics and Laws ↦ Clinical Trials Ordinance ↦ Standardized Transplant Products

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