Swissmedic has optimised the options for meetings with applicants so that the questions posed by companies in connection with the development and authorisation of medicinal products can be clarified together with Swissmedic in an efficient and targeted dialogue.
Companies can now request a Meeting before application submission with Swissmedic at any phase of development of a medicinal product. The newly designed meeting enables companies to have an early dialogue with Swissmedic and should help companies to clarify content- and process-related questions with Swissmedic. The new Meeting before application submission combines the former Scientific Advice Meeting, Pipeline Meeting and Presubmission Meeting. Mutual sharing of scientific information is also possible during the Meeting before application submission.
The Meeting before application submission is not linked to a specific future authorisation application and is valid for all procedures. It is possible to address a combination of discussion topics.
Swissmedic has revised the Guidance document Meetings for applicants for authorisation procedures accordingly and made other editorial changes. The Guidance document Meetings for applicants for authorisation procedures and the new Meeting before application submission come into effect from 1 April 2025.