Background
After the scientific assessment, revisions of the medicinal product information texts and/or packaging elements may require additional text review letters. However, these result in longer overall throughput times and should therefore be avoided where possible. With this in mind, Swissmedic already implemented various measures to optimise the labelling phase between 2017 and 2020 (see SMJ 07/2017, SMJ 05/2019 and SMJ 06/2020). Despite the positive effects of these measures, Swissmedic has noted a renewed increase in applications with additional text review letters. Swissmedic is therefore introducing further measures to optimise the labelling phase for human medicinal products with effect from 1 January 2025.
1. In-depth dialogue between Swissmedic and company in the labelling phase
All applications with product information texts
Since 1 October 2017, it has been possible to also use the eGovernment portal for dialogue with the applicant, without interrupting the Swissmedic evaluation phase. The aim here is to clarify simple, unresolved questions about the medicinal product information texts in direct dialogue within five calendar days (SMJ 07/2017).
To avoid text review letters wherever possible, greater use should be made of this direct dialogue by means of an informal letter via the eGov portal. With effect from 1 January 2025, the following will therefore apply for all new applications with product information texts:
- The unresolved points will now be addressed directly in the relevant manuscripts and the revised medicinal product information texts through informal dialogue via the eGov portal. As currently, no new eCTD sequence will be required.
- The company timeline can be extended once on request by five calendar days.
Official text review rounds with longer timelines should then only be initiated if additional documentation is required or more time (> 10 calendar days) is required by the applicant to clarify unresolved points (e.g. due to more comprehensive investigations).
2. Shorter Swissmedic timelines in the labelling phase
New notifications with a new active substance
In the event that an official text review letter cannot be avoided, Swissmedic is reducing its timelines for new notifications with a new active substance for the application phase “Review of response to text review letter” from the 90 (current) to 45 calendar days.
The measures will come into effect for all applications on 1 January 2025.