Your Easy Guide to Clinical Studies

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

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

External Links

Swissmedic – see in particular

• Human medicines / Authorisations / Information / Optimising authorisation-related meetings with applicants