1 September 2024 – Swissmedic has introduced several key updates to its procedures for authorization applications, effective 1 September 2024. These changes aim to streamline processes and enhance the efficiency of submissions.

1. Update on «Doc. OK» milestone procedures

Swissmedic has revised its guidance document «Time Limits for Authorization Applications» to standardize the management of the «Doc. OK» milestone. Going forward, Swissmedic will no longer issue written notifications about the achievement of this milestone following a formal objection. If an application's documentation is complete and correct during the «Formal Control and Technical Validation» phase, it will be accepted as valid, marking the milestone as achieved. Written notifications after a formal objection have been discontinued. The updated procedures are detailed in the revised guidance document.

For more information, see here.

2. New procedure for submitting accompanying documentation

Swissmedic now permits the direct submission of additional accompanying documentation for applications for authorisation and variation for human medicinal products via the eGov portal. Applicants can upload electronic data sets in «SEND» format (Standard for the Exchange of Nonclinical Data), pivotal bioequivalence study data sets, and films related to the safety, efficacy, and quality of medicinal products. These submissions can be made alongside eCTD and eDok dossiers, streamlining the process.

For more information, see here.

3. Introduction of new forms and information sheet for combined studies

Swissmedic has introduced new forms and an updated information sheet to facilitate submissions for combined studies involving medicinal products and medical devices. Clinical trials for medicinal products or advanced therapy medicinal products that coincide with clinical investigations of medical devices or interventional performance studies of in vitro diagnostics must meet all applicable requirements.

For more information, see here.

4. Acceptance of SEND data for new authorization applications

Swissmedic now accepts «SEND» data (Standard for the Exchange of Nonclinical Data) sets for new authorization applications involving medicinal products with new active substances. This update aligns with the U.S. Food and Drug Administration’s (FDA) Data Standards Catalog (April 2024). While the submission of SEND data is optional, it will support more efficient data analysis, though decisions will primarily rely on study reports in PDF format.

For more information, see here.

5. Updated submission process for QR code authorization

Swissmedic has updated its procedures to accept films as part of the QR code authorization process. Applicants can now submit films and their scripts via the portal when applying for QR code authorization. This allows QR codes to link to films providing additional information on the safety, efficacy, and quality of medicinal products.

For more information, see here.

6. Acceptance of electronic data sets from pivotal bioequivalence studies

Swissmedic now accepts electronic data sets from pivotal bioequivalence studies for new authorization applications involving medicinal products with known active substances. This applies to studies with a two-way, three-way, or four-way crossover design. While submission of these data sets is optional, it enhances the efficiency of data analysis.

For more information, see here.