Klinische Prüfungen NEU – Änderungen im Arzneimittelrecht durch den Geltungsbeginn der VO (EU) 536/2014 und die AMG-Novelle BGBl I 2022/8 (Teil 1).

With the entry into force of Regulation (EU) 536/2014 and the AMG amendment BGBl I 2022/8, comprehensive changes were introduced in pharmaceutical law. The EU Regulation on clinical trials with human medicinal products replaced the existing system six months after its publication. The amendment to the Austrian Medicines Act came into effect retrospectively on February 1, 2022. This article provides an overview of the new regulations and the role of ethics committees in the approval process for clinical trials. The terms "clinical study" and "clinical trial" are also defined and their differences explained. According to Article 2(2)(4), a "non-interventional study" is a clinical study that is not a clinical trial. Therefore, all clinical studies are classified as either a subcategory of a clinical trial or a non-interventional study. The distinction between these two groups of clinical studies is of significant importance, as Regulation (EU) 536/2014 only covers clinical trials. Non-interventional studies are subject to their own national requirements under the Medicines Act. There are also various subcategories of clinical trials, including minimal-interventional clinical trials, commercial and non-commercial (academic) clinical trials, cluster trials, and post-authorization safety studies. The text describes the new approval process for clinical trials in pharmaceutical law. It explains that trial sites can be hospitals, medical practices, or scientific institutions. Actions outside of trial sites are assigned to the corresponding trial site. It also highlights the establishment of the "EU portal" and the "EU database" through which communication between sponsors and national authorities takes place. The new approval process includes a joint assessment procedure and a national assessment procedure. Ethics committees play a role in the approval process and review aspects of the application. The article describes the new regulations for ethics committees in pharmaceutical law. It emphasizes that consultations and voting can now also be done electronically if necessary to meet procedural deadlines. Ethics committees have the right to consult experts and request opinions. It is also mentioned that local ethics committees can be asked for opinions. The requirements for assessing ethics committees and their composition are also explained. It is emphasized that specialists in pharmacology and toxicology or individuals with equivalent pharmacological expertise must be involved. Another innovation is the establishment of a platform that serves as a central point of contact for the assessment of clinical trials by ethics committees. Finally, the obligations to provide information and the supervision of ethics committees are described. [Extracted from the article]