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KMID : 1142220210160020103
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Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 2 p.103 ~ p.116
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Consideration from the Regulatory Perspective for Boosting Domestic Drug Substance Industry
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Kim Ye-Rin
Bong Woo-Ri
Yoo Jung-Min
Nam Kyu-Yeol
Jung Won-Tae
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Abstract
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The dependence on imports of drug substances have been increased due to the low-price competitiveness, insufficient policy supports from the government, and strengthened quality regulations. As a result, the domestic drug substance industry is gradually shrinking. If there is a disruption in the supply of drug substance, it will not only lead the supply shortage, but also give rise to the confusion of overall pharmaceutical industry in the Republic of Korea. Recently, several imported drug substances have had many quality issues. There are lots of difficulties and charges in quality control and supervision of them. In addition, various problems may occur due to high dependence on foreign countries, such as unstable drug supply and monopoly. Many countries such as the US, Europe, and India are establishing government policies for self-reliant drug substance supply, realizing that it is directly related to national security. On the other hand, in South Korea, there is almost no policy supporting domestic drug substance industry so far, and it is only recently seeking ways to strengthen the competitiveness of drug substances. It is expected that this paper can be utilized as a reference for the introduction and establishment of policies to revitalize the domestic drug substance industry.
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KEYWORD
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Drug substance, Import dependence, Domestic drug substance industry, Self-reliant p olicy, System improvements
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