What is it? Why is it important?
Swissmedic is the Swiss authority regarding the licensing, authorization, and/or monitoring of therapeutic products, including:
- Human medicine
- Veterinary medicine
- Complementary & herbal medicine
- Medical device
Core competencies include to:
- Approve studies. In comparison to the Ethics Committee (EC) Swissmedic only approves higher risk studies (e.g. risk categories), such as:
- Issue licences for the manufacturing of MPs
- Authorise MPs to be sold on the Swiss market
- Inspect studies and their compliance with regulatory requirements and guidelines (e.g. Swiss Law, ICH GCP, ISO 14155)
- Monitor the safety and quality of MPs/MDs in studies and on the open market
- Inspect manufacturing companies to evaluate the quality of MPs/MDs
- Issue information aimed at healthcare professionals and patients
- Cooperate with national and international agencies
In comparison to MP authorisation requirements, Medical Devices do not undergo official Swissmedic authorisation procedures. For devices, Switzerland has taken over the EU system of compliance and assessment certification. The visible result of a compliance assessment is the so-called CE label, which permits medical devices to be placed / sold on the market.
Swissmedic is attached to the Federal Department of Home Affairs.
What do I need to do?
Submission can be done concurrently with the EC submission. EC submission is required for all studies irrespective of the risk-category of the study.
As a SP-INV or Site-INV, keep in mind to notify to Swissmedic any:
- Changes to the conduct if your study (e.g. amendments)
- Changes to the ongoing risk-benefit evaluation
- Other reporting obligations (e.g. first-patient-in, safety reporting, annual safety report, study completion and clinical study report)
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
Swissmedic – see in particular
- Human medicines / Clinical trials
- Medical devices / Clinical trials
ICH GCP E6(R2) – see in particular article
- Art. 1.49 Definition regulatory authorities
KOFAM: Coordination portal for human research – see in particular
- Online wizard for risk categorisation