What is it? Why is it important?
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?
- 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
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
KOFAM: Coordination portal for human research – see in particular
- Online wizard for risk categorisation
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