Update guidance for Art. 14abis-quater applications

Can unpublished clinical study reports be submitted as clinical evidence in applications according to Art. 14abis-quater?

Swissmedic accepts findings from unpublished clinical study reports as supportive evidence as a supplement to the bibliographic documentation, provided that the results of the studies are evaluated and / or presented in a scientifically sound manner and accompanied by an expert statement. In addition to the updated guideline “Authorisation according to Art. 14 para. 1 abis-quater TPA HMV4” Swissmedic has also updated the Q&A accordingly.

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