Korea: Multinational Device Clinical Trial Approved

The Korea Food and Drug Administration (KFDA) recently approved the first multinational clinical trial for a medical device. The device, the Nobori drug-eluting stent, is manufactured by the Terumo Corporation, an international medical device company headquartered in Tokyo, Japan. The trial involves 360 study subjects from thirty testing centers located in Europe, Australia, and Asia. Until now, the KFDA had only approved multinational clinical trials for drugs.

The KFDA has been proactively encouraging multinational clinical trials in Korea, and over the last five years, multinational trials (for drugs) have increased dramatically as a result. For example, in 2000, only 5 multinational drug clinical trials were approved by the KFDA, compared to 28 local trials. In 2002, there were 17 multinational drug clinical trials and 38 local trials. However, by 2005, the number of multinational trials surpassed the number of local trials; the KFDA approved 95 multinational drug clinical trials, whereas it approved only 90 local clinical trials. Now that the KFDA has approved the first clinical trial for a medical device, it hopes that the number of multinational clinical studies will continue to increase—for both drugs and devices.

The KFDA hopes that increasing the number of multinational trials will enhance the quality of domestic clinical studies through the introduction of new foreign drug and device technologies. In addition, more multinational trials in Korea will help to develop local expertise in conducting studies that meet international standards. The KFDA hopes that this will demonstrate that Korea’s drug and device industries have reached quality standards similar to those in other advanced countries. In addition, the Korean medical community hopes that this will attract more foreign medical companies to invest in Korea and further develop its medical sector.