Die nationale Begleitgesetzgebung zum Genehmigungsverfahren klinischer Prüfungen mit Humanarzneimitteln im Rahmen der Verordnung (EU) Nr. 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). The 4th AMGÄndG provided for legal amendments to the Medicinal Products Act (AMG) that came into force in advance of the date of application of the CTR. Essentially, this concerns the introduction of a registration obligation for ethics committees at the Federal Institute for Drugs and Medical Devices (BfArM). In addition, the 4th AMGÄndG contains regulations that came into force at the beginning of 2022, in parallel with the date of application of the CTR. The Regulation on the application of Good Clinical Practice in the conduct of clinical trials of medicinal products for human use (GCP-Regulation, GCP-V) was repealed. The 6th section of the AMG on the protection of humans in clinical trials has been rewritten to supplement the requirements of the CTR and to fit the procedural flow into the national legal system. In particular, this concerns the regulations on the cooperation between higher federal authorities and ethics committees, such as responsibilities, deadlines, procedures and fees. Regulations were also made for the national procedure of release authorisation for clinical trials with medicinal products containing or consisting of genetically modified organisms (GMOs) as well as special protective regulations for special groups of participants.