Basic↦Ethics and Laws↦Clinical Trials Ordinance↦Medicinal Product Studies
Was betrifft es? Warum ist das wichtig?
The Human Research Act (HRA) regulates through its Clinical Trials Ordinance (ClinO) studies with Medicinal Products (MP). A MP tested in a study, is named an Investigational MP (IMP).
Studies with medicinal products are divided into three risk-categories (e.g. risk categories A, B, or C apply, with A having the lowest and C the highest risk).
Category A: The IMP
- Is authorised in Switzerland (market authorised)
- Has not been modified and used:
- In accordance with the prescribing information (PI)
- In indication or dosage different from PI but a) within the same ICD disease group b) the disease is self-limiting and the IMP dosage is lower than in PI
- Is recognised as standard guidelines prepared in accordance with international quality criteria
- Is recognised as standard guidelines prepared in accordance with international quality criteria
Category B: the IMP is:
- Authorised in Switzerland; and
- Not used as specified in category A, or
- Has undergone a low-risk modification (details under more)
- Authorised in a country that has equivalent MP control and has not been modified or undergone a low-risk modification
- Placebo manufactured for the study
Category C: the IMP is:
- Authorised (market authorised) in Switzerland or a country with equivalent MP control, but has undergone more than a low-risk modification
- Not authorised in Switzerland or a country with equivalent MP control
Mehr
Low-risk modifications of an IMP are:
- Modifications to the secondary packaging
- Modification to the primary packaging, provided that the IMP is not sterile or an immunological product (shelf-life must not be impaired)
- Modification by over-encapsulation, which does not affect absorption (shelf-life must not be impaired)
Was muss ich befolgen?
As a SP-INV planning an IMP study, you are required to know and comply with the requirements defined in the ClinO ordinance.
Based on the risk-category of your study, submit your application dossier to:
- The Ethics Committee (EC) who grants authorisation of risk-category A, B, and C studies. The EC provides a reply, after acknowledgement of receipt of the formally correct application documents (application dossier), within:
- 30 days for monocentric studies
- 45 days for multi-centre studies
- Swissmedic who grants authorisation of risk-category B and C studies. Swissmediic provides a reply, after acknowledgement of receipt of the formally correct application documents (application dossier), within:
- 30 days
- A potential additional 30 days for first in human studies, or for IMPs manufactured in a new process
Submission to Swissmedic (submission) and EC (submission) may be done in parallel.
Submission to the second authority must be done within two years after approval of the first authority.
Wo kann ich Hilfe anfordern?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
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
HumRes: Coordination portal for human research in Switzerland
Swiss Law
ClinO – see in particular articles and annexes
- Art.19 Categorisation of IMP studies
- Art. 23 Coordination and information in approval procedures
- Art. 26 Procedures and deadlines EC
- Art. 27 Procedures and deadlines EC in multi-centre clinical trials
- Art. 33 Procedures and deadlines Swissmedic
- Annex 3 Application documents to EC
- Annex 4 Application documents to Swissmedic / FOPH