Development↦Ethics and Laws↦Swissmedic Application↦Late Clarification Meeting
Was betrifft es? Warum ist das wichtig?
After a preliminary approval round, Swissmedic might still have some remaining issues that need clarification (e.g. IMP labelling, Swiss Expert Committee for Biosafety). As a consequence, Swissmedic can request a Late Clarification Meeting (LCM). This avoids additional rounds of text reviews and saves time.
For the LCM Swissmedic will:
- Forward any remaining and open issues to the SP-INV in writing
- Request that the SP-INV decides on the preferred communication mode (e.g. by teleconference, in writing)
Chronology of a Swissmedic application including the potential for an Early- and Late clarification meeting:
- The SP-INV submits the study to Swissmedic
- Swissmedic forwards a list of questions to the SP-INV
- SP-INV requests an Early Clarification Meeting (ECM)
- Upon the ECM, Swissmedic reaches a preliminary decision with some remaining questions
- The SP-INV replies to Swissmedic questions
- Swissmedic requests a Late Clarification Meeting (LCM)
- Upon a LCM, Swissmedic reaches a final decision regarding study approval
Was muss ich befolgen?
As a SP-INV:
- Inform Swissmedic of the preferred communication mode within 5 days
- After Swissmedic agrees on the selected communication mode:
- Reply in writing to all open issues within 10 days
- Contact Swissmedic and agree on a meeting within the next 5 to10 days
For the LCM:
- Swissmedic chairs the meeting
- Only prepare answers to questions forwarded by Swissmedic
- Be short and concise
- Take minutes during the meeting
- After the meeting, submit minutes to Swissmedic for approval
Wo kann ich Hilfe anfordern?
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
External Links
Swissmedic – see in particular
- Human medicines / Authorisations / Information / Optimising authorisation-related meetings with applicants