Recommendations of SÚKL for submitters of bioequivalence (BE) studies

Applicants for BE studies often do not include some of the required documents when submitting their application for accelerated study assessment or incorrect payment is made, which subsequently increases the assessment time. For this reason, SÚKL has issued short guidance on its website regarding the documentation requirements for bioequivalence (BE) studies submitted through CTIS together with payment information so that the study can be successfully validated and subsequently assessed under the accelerated regime.  In the link you will find both a list of these documents, but also information on the amount of the payment and the payment method, so that the assessment is not delayed in the validation phase by the completion of comments.

The full text can be found here: Recommendations on the Content of Dossiers Submitted for Bioequivalence (BE) Studies Allowing for Assessment within Accelerated Timeframe, State Institute for Drug Control (sukl.eu)