To ensure that questions from companies relating to the development and approval of medicinal products can be clarified efficiently and purposefully in dialogue with Swissmedic, it has optimised the possibilities for company meetings.
- Companies can now request a pre-submission meeting with Swissmedic at any stage of a drug development project.
- This newly designed meeting allows companies to engage in early communication with Swissmedic and is intended to help clarify content and procedural issues they have with Swissmedic.
- The new pre-submission meeting combines the following existing meeting types :
- “Scientific Advice Meeting,”
- “Pipeline Meeting,” and
- “Presubmission Meeting”
- A mutual exchange of scientific information is also possible within the pre-submission meeting.
- The pre-application meeting is not tied to a specific future application for approval and applies to all procedures. A combination of meeting topics is possible.
- Swissmedic has revised the Guidelines on Company Meetings for Authorization Procedures accordingly and made further editorial adjustments.
- The Guidelines on Company Meetings for Authorization Procedures and the new meeting before application submission takes effect on April 1, 2025.
Source: Swissmedic