[The national legislation accompanying the approval procedure for clinical trials of medicinal products for human use under Regulation (EU) No. 536/2014].

The Regulation (EU) No 536/2014 (Clinical Trials Regulation [CTR]) on clinical trials on medicinal products for human use is a challenge not only for sponsors but also for national authorities and ethics committees. Thus, fundamental structural changes were necessary for the establishment of the novel authorisation procedure. The necessary accompanying law was created in 2016 with the Fourth Law on the Amendment of the Medicinal Products Act (4th AMGÄndG) and in 2017 with the Clinical Trial Assessment Procedure Ordinance (KPBV).