The Korea Food and Drug
Administration (KFDA), which was established in 1996, is the main
regulatory body for drugs and medical devices, and is responsible
for granting approval.
Clinical trials must be conducted in accordance with Korean Good Clinical
Practice (KGCP), which was implemented in 1995. In 2001, KGCP was
revised, based on ICH GCP.
According to Korean Good Clinical Practice, clinical trials must be
reviewed and continuously monitored by Institutional Review Boards
(IRBs). The Korean Association of Institutional Review Boards was
founded in 2002. It will play an important role in supporting local
IRBs, and aims at raising the quality of ethical review to the international
level.
 Health
Care System |
In South Korea's health
care system, western medicine and oriental medicine coexist.
More than 90% of the health care services in South Korea are provided by the private sector. Fewer than 80 of the total number of over 800 hospitals are public hospitals. These public hospitals are either large national hospitals or public general hospitals. Hospitals are mainly concentrated in urban areas, particularly in Seoul and Pusan and other cities. In order to improve rural health care, a number of primary health care facilities have been established in rural areas by the government in recent years. There are now over 3,400 public health centres and primary health care posts in rural areas.
Health care services are reimbursed by the national health insurance scheme (covering all citizens in accordance with the National Health Insurance Act), together with co-payments paid by the patient.
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SOUTH
KOREA 
