1 January 2025
Swissmedic: Optimization of the labelling phase for human medicinal products
Swissmedic has announced that, starting 1 January 2025, the labelling phase for human medicinal products will be optimized with the goal of reducing overall processing times and minimizing additional text review letters. Measures to improve efficiency were implemented in 2017 and 2020, however, an increase in applications requiring text review letters has been observed. To address this, the direct dialogue between Swissmedic and the companies will be intensified. Unresolved issues will now be addressed directly in the relevant manuscripts and exchanged informally via the eGovernment portal, with an extension of up to five calendar days available.
Additionally, the timeline for processing new notifications with a new active substance, if an official text review letter cannot be avoided, will be reduced from 90 to 45 calendar days.
For more information, see here.
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