통합 임상시험법 제정을 위한 기초 연구 - 임상시험 법제의 개선방향을 중심으로 -

Abstract

Surrounding this new clinical trial environment change, countries including Korea are seeking various solutions, and among them, legislative solutions through the reconstruction of related legislations become the main trend. Nevertheless, in Korea, there are only a few articles related to clinical trials in the Pharmaceutical Affairs Act and the Medical Device Act, which are the core laws governing clinical trials of medicinal product and medical devices in Korea, creating a wide legislative gap. In addition, since clinical trial-related affairs are delegated to the a lot of lower statutes and regulations, it is difficult to find out which affairs are regulated in which statutes or regulations. These problems eventually act as a major factor hindering the development of new medicinal products or medical devices. This study is premised on the need for a unified and systematic regulations for clinical trials of medicinal products and medical devices from the viewpoint of securing the safety and effectiveness of clinical trials. As a part of the basic studies for the integrated management of clinical trials, this paper researches the current situation and problems in Korea, and reviews the clinical trial legislation of major foreign countries from the viewpoint of comparative law in order to obtain implications for finding improvement plans. Through these studies, the author derives a plan to improve the legal system for clinical trials, and proposes a legislation for the integrated management of clinical trials for medicinal products and medical devices. In conclusion, clinical trial procedures and legal regulations for medicinal products and medical devices are substantially in common. As integrated management system for clinical trials that encompass medicinal products and medical devices, the integrated legislation rather than the revision of the existing Pharmaceutical Affairs Act and Medical Devices Act are recommended. So the authors proposes the enactment of the tentatively named ‘Medicinal Products and Medical Devices Clinical Trial Act(abbreviated ‘Clinical Trial Act’).