In November 2019, the European Commission released a revised version of the Q&A document on the Clinical Trials Regulation EU 536/2014. The main changes introduced to the former draft guidance refer to: (i) Question 1.7 of the Q&A. In this case, the question posted refers to whether a study where a medicinal product is administered for the sole purpose of studying the physiology of the body, if such study qualifies as a "clinical trial" as such term is defined in the Clinical Trials Regulation. In this regard, the answer provided is that studies of this sort, where the objective is to investigate the physiology of the body, do not qualify as clinical trials and, therefore, the medicinal product administered is not an investigational medicinal product. As an exception, where the object of an investigation is being "switched" in the course of the same study, i.e., from the physiology of the body to the pharmacological effect triggered by the medicinal product, then such study may "turn into" a clinical trial. (ii) Question 2.8 of the Q&A. This question refers to the conditions to which a clinical trial may be subject in order to be authorized. In this regard, the Q&A specifically sets out that where conditions are being set out, it implies that the benefit/risk balance of the clinical trial is positive and that such conditions cannot be fulfilled at the time of the authorization. If the benefit/risk balance of the clinical trial is negative, the application should be rejected. (iii) Question 5.2 of the Q&A. Such question refers to how responsibilities are shared among co-sponsors on a clinical trial. The general principle is that the sponsor's obligations can be jointly attributed to all co-sponsors. Therefore, all of them may be held liable for non-compliance with the sponsor's obligations. However, the Q&A specifically sets out that there is, at least, one scenario where the co-sponsors shall mutually agree in writing to distribute the following tasks among them, so that non-compliance with such specific task will be exclusively attributed to the co-sponsor that assumed such responsibility: (i) compliance with a sponsor's obligations in the authorization procedure; (ii) to be a contact point for receiving questions from subjects, investigators or any Member State concerned regarding the clinical trial and for replying to them; and (iii) implementing corrective measures imposed by any of the Member States concerned.
Further information can be obtained in the following link: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf