What is it? Why is it important?
For studies with an Investigational Medicinal Product (IMP), Swissmedic acknowledges the receipt of an application dossier within 7 days.
Swissmedic makes a formal evaluation whether the application dossier is complete, or if documents are:
- Missing, and/or
- Incomplete, and/or
- Not correctly filed
In the event of an incomplete dossiers the SP-INV is asked to update the dossier within a given deadline.
Swissmedic provides an answer whether the application has been approved:
- Within 30 days
- Or between 30 and 60 days if the product:
- Has never been tested in humans (first in man, phase I studies); or
- Is manufactured based on new production procedures
Once submitted to Swissmedic the study is given an individualised reference number. This number is included in all future Swissmedic correspondence.
If prior to approval, Swissmedic still has open issues regarding the application dossier, they will forward a preliminary decision letter listing what documents must still be:
- Submitted and/or
- Changed / adapted
As a consequence, the application time clock is stopped until all requested documents are forwarded and/or all requested changes are made.
A rejected study by Swissmedic cannot be re-submitted. Any required adaptations would result in a new study and totally new submission.
Approval timelines for studies using an IMP and MD in combination (in vitro), depends on the conformity of each product (e.g. consult Swissmedic tables regarding potential combination).
What do I need to do?
If prior to approval, Swissmedic requires additional information or changes to the application dossier, submit:
- A cover letter
- An updated CTA, if required
- Additionally required documents and/or information
- Required modifications (e.g. to submitted documents)
The study can only start after Swissmedic, EC, and if applicable FOPH have approved the study.
After approval the SP-INV ensures that:
- The Swissmedic reference number is included in all future correspondence
- A robust document tracking system is in place (e.g. ensures that only Swissmedic approved documents are used in the study)
- Modifications made to approved documents are re-submitted for approval prior to implementation (e.g. including EC approval)
File all Swissmedic correspondence including the official Swissmedic approval document in the TMF, and if applicable in the ISF of participating study sites.
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
Swissmedic – see in particular
- Human medicine / Clinical trials / Clinical trials on medicinal products
- Medical devices / Clinical trials / Authorisation procedure
- Services & Lists / eGOV services
- Services & Lists / submissions
FEDLEX – laws are available online under numbers
- 810.305 ClinO
- 812.21 TPA
ClinO – see in particular articles
- Art. 23 Coordination in authorisation procedures
- Art. 30 Exemption from authorisation
- Art. 32 Review areas
- Art. 33 Procedure and deadlines
TPA – see in particular article
- Art. 54 Mandatory authorisation