Intensified exchange Swissmedic – Company in the labelling phase
In order to avoid text review letters whenever possible, this direct exchange by means of an informal letter via the eGov portal should be used more frequently. Therefore, from January 1, 2025, the following will apply to all applications with drug information texts:
- The open points will now be addressed directly in the corresponding manuscripts and the revised drug information texts will be exchanged via informal exchange on the eGov portal. As before, no new eCTD sequence is required for this.
- The company deadline can now be extended once by 5 calendar days upon request.
Official text review rounds with longer deadlines should only be initiated if additional documentation is necessary or if the applicant needs more time (> 10 calendar days) to clarify the open points (e.g. due to more extensive clarifications).
Shortening of Swissmedic deadlines in the labelling phase (for new applications with new active substances)
In cases where an official text review letter cannot be avoided, Swissmedic is shortening its deadline for the application phase ‘Assessment of response to text review letter’ for new applications with a new active substance from 90 to 45 calendar days from 1 January 2025.
Source: Swissmedic