Recently, as interest in new health technology has been increasing, the health care industry has received attention as a future core industry in the Republic of Korea. To implement newly developed medical devices in Korea, their electrical, mechanical, physicochemical, radiological, biological, and electromagnetic safety and efficacy have to be verified though the regulatory process of the Ministry of Food and Drug Safety (MFDS). If the new health technology is produced, the safety and efficacy of the technology have to be verified through the process of new health technology assessment (nHTA) under the Committee for New Health Technology Assessment (CnHTA). Since nHTA was introduced in 2007 to protect public health and develop health technology, it has become clear that greater speed and efficiency of the nHTA process is strongly needed. In this study, the purpose and function of nHTA are analyzed, beginning with its establishment all the way through recent performance outcomes. The implications of nHTA in clinical trials for the life-cycle of health technology is also discussed. We analyzed 1,609 cases from 1 May 2007 to 30 September 2014. A mong the 1,609 cases, 1,563 cases (97.1%) underwent complete assessment and judgment. Among them, 737 cases completed the entire nHTA process with th e CnHTA. Among these cases, 565 of the cases (76.7%) were approved, and 139 cases (18.9%)
entered the research phase, in which the technology is not yet allowed to be used in clinical medicine in the general market. In an analysis of the application type of the 1,609 cases, almost all of the health technology applications were produced by advanced general hospitals and manufacturers for diagnosis, intervention, and genetic testing. We suggest that several complementary systems be established: a one-stop service, temporary approval of new health technology, and an R&D support system based on the lifecycle of health technology.
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