A four-year benchmark study conducted by Swissmedic indicated that there are potential improvements to be made to the labelling phase to speed up the drug authorisation process. Changes are proposed to make the review and finalisation of the labelling more efficient and to significantly reduce the number of text reviews that are the primary cause of the long labelling phase.
The proposed changes are being tested in a pilot phase that started on 1st October 2017 and will be applied to on-going application that have not reached the labelling phase as well as any new applications submitted after this date.
The measures that have been introduced are:
- Swissmedic will provide feedback on the product information in the form of a revised manuscripts with the List of Questions (LoQ). The aim of this measure is to initiate early dialogue on the product information for healthcare professionals and patients.
- Applicants should submit packaging mock-ups in the initial application. This change should ensure packaging materials have been reviewed earlier in the process and are satisfactory by the time of the preliminary decision.
- The period for replying to the preliminary decision and text review rounds will be shortened from 90 to 60 calendar days.
- In the future, Swissmedic will be using the eGovernment Portal to share information with applicants without having to interrupt the SMC evaluation phase. The aim of this measure is to clarify simple, unresolved questions within 5 calendar days in a direct dialogue.
- In some cases, the throughput time for applications is extended by additional text review rounds, without the applicants submitting new or additional information that would form the basis for modification of the product information texts. In such cases, Swissmedic can, after granting the due process hearing, issue an official decision directly and without additional text review rounds.