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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Clinical Practice in the conduct of clinical trials of medicinal products for human use (GCP-Regulation, GCP-V) was repealed.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., (© 2022. The Author(s).)

Objective: The aim of this pilot study was to compare a German (Bavaria) and an American (North Dakota) sample of women suffering from compulsive buying., Method: Thirty-eight German and 39 American female compulsive buyers were screened with the Compulsive Buying Scale (CBS), and the Yale-Brown Obsessive Compulsive Scale-Shopping Version (Y-BOCS-SV) prior to entering a group treatment study. Psychiatric co-morbidity was assessed with the Structured Clinical Interview for DSM-IV Axis I disorders (SCID)., Results: There were no statistically significant differences between the German sample and the American sample with regard to age (mean 43.7 and 45 years, respectively), and with regard to the scores on the CBS and the Y-BOCS-SV. A high lifetime co-morbidity rate with Axis I disorders, especially mood disorders, anxiety disorders, substance use disorders, OCD, and binge eating disorder was detected in both samples. Almost all participants met criteria for at least one lifetime Axis I disorder. However, German compulsive buyers showed significantly higher current prevalence rates of any affective disorder, and higher current and lifetime prevalence rates of any anxiety disorder and somatoform disorder. In addition, German compulsive buyers were significantly more likely to have more than one Axis I disorder., Conclusion: The groups did not differ with regard to age and with regard to the severity of compulsive buying and showed a high co-morbidity with Axis I disorders. However, the German compulsive buying sample presented with significantly more psychiatric co-morbidity compared to the American sample. Further research is needed to provide a better understanding of this disorder in general and cross-culturally.