Klinische Prüfungen NEU – Änderungen im Arzneimittelrecht durch den Geltungsbeginn der VO (EU) 536/2014 und die AMG-Novelle BGBl I 2022/8 (Teil 2).

With the entry into force of Regulation (EU) 536/2014 on clinical trials with medicinal products for human use on February 1, 2022, a comprehensive reorganization of clinical drug trials within the European Union was initiated. This article provides an overview of relevant key points of the EU regulation as well as the specific adjustments of Austrian pharmaceutical law through the AMG amendment BGBl I 2022/8. The approval process for clinical trials is initiated by the submission of the application dossier by the sponsor via the EU portal. There are three options for validation, depending on whether the clinical trial falls under the regulation and the application is complete or not. The responsibilities regarding Part I of the evaluation process are divided between BASG and the reviewing ethics committee. Austrian legislation has made changes related to clinical drug trials, including the use of the English language for multinational clinical trials and new provisions for sponsors. There are also new regulations for the protection of vulnerable groups in clinical trials. Regulation (EU) 536/2014 and the AMG (Medicinal Products Act) BGBl I 2022/8 bring comprehensive changes to clinical drug trials in order to make EU member states more attractive as research and development locations and to strengthen the role of the EU in the pharmaceutical industry. [Extracted from the article]