In the greatly simplified procedure according to Art. 14 para. 1 letter abis TPA, a review of original clinical documentation is generally only admissible for bioequivalence studies, e.g. where the pharmaceutical forms differ.
As an addition to the bibliographical documentation, Swissmedic accepts findings from non-published clinical study reports as supporting evidence, provided the results of the studies have been assessed and shown to be scientifically reliable and are accompanied by an expert statement. In the expert statement, the applicant must critically evaluate these study results in terms of efficacy and safety as part of an overall summary of the evidence submitted. Moreover, the expert statement should state the extent to which the study results are applicable to the medicinal product for which authorisation is being applied for and to the foreign reference medicinal product, and should critically evaluate any deviations e.g. in terms of composition and pharmaceutical form.
Swissmedic has updated the Q&A and the guidance document Authorisation according to Art. 14 para. 1 abis-quater TPA HMV4 accordingly.