Abstract
Following government initiatives in the mid-1980s to change the mechanism by which new drugs are approved, the popularity of clinical drug trials has increased among the drug industry and academia of Korea. The Korean drug authority requested in the early 1990s that the drug industry maintain the minimum principles of the Declaration of Helsinki, such as establishing institutional review board (IRB) reviews and obtaining written informed consent for regulatory controlled drug trials. The Korean Good Clinical Practice (KGCP) guidelines were legislated and became effective as of October 1, 1995. Although implementation of the KGCP increased the burden on the drug industry and on medical institutions, its enforcement has brought about remarkably positive changes in the infrastructure and quality of clinical drug trials in this country. Moreover, it has promoted collaborative educational activities between the government and academic institutions. These improvements will likely raise the standards for other clinical research initiatives in Korea that involve human subjects.
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