What is it? Why is it important?

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

What do I need to do?

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

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissmedic – see in particular

  • Human medicines / Authorisations / Information / Optimising authorisation-related meetings with applicants
Abbreviations
  • CTU – Clinical Trials Unit
  • ECM – Early Clarification Meeting
  • LCM – Late Clarification Meeting
  • SP-INV - Sponsor Investigator
Development ↦ Ethics and Laws ↦ Swissmedic Application ↦ Late Clarification Meeting
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Development ↦ Ethics and Laws ↦ Swissmedic Application ↦ Late Clarification Meeting

Please note: the Easy-GCS tool is currently under construction.