From 1 September 2024, Swissmedic is accepting electronic data sets from pivotal bioequivalence studies for applications for new authorisation of human medicinal products with known active substances without innovation. This option is restricted to bioequivalence studies with a two-way, three-way or four-way crossover design.
Submission of these electronic data sets enables Swissmedic to analyse data effectively and efficiently using the latest state of science and technology. Swissmedic does not require any additional data, but only recommends submitting the data in a standardised electronic format. Submission is not mandatory and Swissmedic will continue to base its decisions on study reports in PDF format.
Section 6.5 Data sets relating to studies has accordingly been added to the form New authorisation of human medicinal products and section 6.5.2 Pharmacokinetic bridging has been revised in the guidance document Authorisation of human medicinal product with known active substance. Further information on the technical requirements regarding data sets are set out in Annex 9.3 of the guidance document Authorisation of human medicinal product with known active substance.
The revised specification documents are valid as of 1 September 2024.
If anything regarding formatting of data sets is unclear, we recommend contacting the responsible Regulatory Manager (see Allocation of ATC codes for human medicinal products).
The technical requirements for transmitting data sets are outlined in the publication Submission of accompanying documentation for applications for authorisation and variation for human medicinal products.