What is it? Why is it important?
Swissmedic is a federal institution acting as a surveillance authority for medicines and medical devices. Swissmedic is thus the regulatory authority of Switzerland.
Any medical product aimed for humans or animals use, needs approval from Swissmedic prior to being distributed on the Swiss market.
Based on ClinO, the following studies must obtain approval by Swissmedic prior to implementation:
- Medical Device category C studies
- Investigational Medicinal- and transplant products with a category B or C study
- Gene therapy, genetically modified pathogenic organism, and ionising radiation with a category B of C study
- Authorizes market access to new therapeutic products based on internationally acknowledged criteria, guaranteeing quality, safety and efficacy
- Specifies conditions of sale (e.g. on prescription only; packaging, labelling, record keeping)
- Approves information for healthcare professionals and patients.
As an inspection authority, Swissmedic focuses on:
- Quality and Safety of IMP/MD
- GCP and GVP
- Risk Management
- Quality of study site(s)
What do I need to do?
In the event your study must be submitted to Swissmedic, visit the Swissmedic website for guidance.
- Useful information guides you through the Clinical Trial Application (CTA) process
- Requirements needed to compile a complete CTA dossier are listed
- As a SP-INV you can simultaneously submit an application to Swissmedic and the EC
The EC and Swissmedic do coordinate their assessments regarding incoming study applications.
For more information refer to Ethics and Laws in this Study Guide.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
ClinO – see in particular article and annex
- Art. 23 Coordination and information in authorisation procedures
- Art. 30-34 Swissmedic Submission, Timelines and Approval Process including Studies with Radiation Source
- Annex 4 Application documents to swissmedic