What is it? Why is it important?

Upon an initial evaluation of the Investigational Medicinal Product (IMP) under investigation, Swissmedic might forward a list of questions to the study SP-INV. In the event of unresolved issues, the SP-INV can request a joint Early Clarification Meeting (ECM).

The aim of the meeting is to:

  • Clarify issues raised by Swissmedic
  • Resolve unsolved issues (e.g. required labelling procedures)
  • Establish an adequate response strategy with Swissmedic

An early clarification meeting:

  • Must be requested by the SP-INV within 2 weeks upon receiving Swissmedic queries
  • Must be justified. Swissmedic retains the right to abstain from a meeting
  • Is liable to costs
  • Must be limited to 1h30

More

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:

  • Prepare a cover letter justifying a joint ECM. Proposes an initial personal clarification (e.g. in order to justify a joint ECM)
  • Prepare a briefing book that:
    • Contains a list of questions that need clarification
    • Does not include new data or issues (e.g. point of reference is the original submission dossier)
    • Does not exceed 4 pages
  • Propose ECM dates (3 options) and mode (e.g. in person, by teleconference)
  • Modification or changes are only allowed until two weeks before the meeting
  • Swissmedic confirms the date and chairs the ECM
  • After the ECM, submit meeting notes 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 ↦ Early 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 ↦ Early Clarification Meeting

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