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KMID : 1142220160110020109
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Regulatory Research on Food, Drug & Cosmetic
2016 Volume.11 No. 2 p.109 ~ p.125
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Analysis of Drug Approval System for Exporting Domestic Drug Products to International Market - Chile
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Lee Dong-Seok
Shin Hwa-Jin
Kim Eun-Hee
Choi Young-Ju
Kim Hee-Sung
Cho Hea-Young
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Abstract
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As a solution to the stagnant domestic pharmaceutical market and the development of the pharmaceutical industry, a new growth strategy called “overseas exports through the development of new drugs and new product” through overseas market exploration was suggested. In this study, we investigate system of approval and regulation in Latin America that is called “emerging country” and draw the reform plan. We translate the law and contents of homepage of Chile into English. Later, we translate this English version into Korean again. We also made charts comparing procedures of IND (Investigational New Drug) and NDA (New Drug Application) through looking into web sites of regulator and literature search, and got specific precautions or necessary informations by investigating the real case of applying new drug permission in Chile. Furthermore, we proposed the objective and professional regulation plan to export domestic drug by meeting with pharmaceutical company and consulting company, domestic and abroad, which had experiences exporting their products in Chile. It is expected that the regulation information written in this paper can improve domestic regulations about permission and inspection globally and help quick global market entry of domestic drug. It could be used as the supporting policies to achieve “Pharma Korea 2020 vision” (jumping to the global top 7 powers in pharmacy in 2020).
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KEYWORD
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International market, Chille, Regulatory harmonization, Growth strategy
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FullTexts / Linksout information
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Listed journal information
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