What is it? Why is it important?

For Medicinal Products (MP) studies, the study SP-INV can request a scientific advice meeting with Swissmedic. Scientific advice meetings:

  • Usually take place:
    • During the conception or development phase of the study
    • Before the study application process (e.g. Ethics Committee (EC), Swissmedic submission)
  • Are recommended in the event of:


The aim for the SP-INV is to obtain an evaluation by Swissmedic whether the:

  • The set-up of the planned study meets the prerequisites for a successful Swissmedic application
  • The overarching goal (e.g. regarding the aim of the study) is reachable, considering that both the scientific and regulatory requirements must be met


Discussions include:

  • The quality of the active pharmaceutical ingredient of the investigated MP (IMP) (e.g. expected health effects)
  • The planning and organisation of pre-clinical and interventional studies
  • The pharmacovigilance and the risk management plan


Swissmedic recommendations are:

  • Binding and must be implemented by the SP-INV
  • Liable to costs. Scientific advice is not free of charge


In the event questions cannot be resolved during the meeting, Swissmedic will follow-up with a written statement.

What do I need to do?

As a SP-INV, submit an application for a joint meeting to Swissmedic. Include the following information:

  • A meeting agenda with a list of questions and issues to discuss
  • A suggestion for potential meeting dates (e.g. within 4 to 8 weeks) and mode (e.g. in person, by TC)
  • List of attendees from the SP-INV team, including their respective functions (e.g. SP-INV, data manager, statistician)


As a SP-INV ensure you:

  • Are well prepared for the meeting. Swissmedic only discusses questions that were submitted prior to the meeting.
  • Submit changes to Swissmedic no later than 2 weeks before the meeting (e.g. adaptation of submitted questions)
  • Are aware that it is not the task of Swissmedic to develop your study protocol


Prior to a meeting, Swissmedic accepts the application and confirms a date. The meeting:

  • Duration must not exceed 1h30
  • Swissmedic chairs the meeting
  • Only pre-defined questions are discussed
  • Keep explanations short and to the point
  • Be confident in questions where you seek an answer
  • Take meeting notes and include decisions taken
  • 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 / Authorisation / Information / Optimising authorisation-related meetings with applicants
  • CTU – Clinical Trials Unit
  • MP – Medical Product
  • IMP – Investigational Medicinal Product
  • SP-INV – Sponsor Investigator
  • TC – Telephone Conference
Concept ↦ Ethics and Laws ↦ Ethics and Regulatory Advice ↦ Swissmedic Scientific Advice

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Concept ↦ Ethics and Laws ↦ Ethics and Regulatory Advice ↦ Swissmedic Scientific Advice

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