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KMID : 1142220160110010093
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Regulatory Research on Food, Drug & Cosmetic
2016 Volume.11 No. 1 p.93 ~ p.107
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Analysis of Drug Approval System for Exporting Domestic Drug Products to International Market - Malaysia
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Lee Dong-Seok
Ko Se-Mi
Park Ok-Nam
Choi Young-Ju
Kim Hee-Sung
Cho Hea-Young
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Abstract
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Domestic pharmaceutical market has stagnated by its scale 18.2 trillion won in 2011, 19.0 trillion won in 2012 and 19.0 trillion won in 2013 and 19.4 trillion won in 2014. The domestic drugs are consumed in country after separation prescribing and dispensing of drugs in 2000. 81.5% of medicine producted in Korea are used internally. It is expected that export of domestic pharmaceutical companies is going to be accelerated owing to limitation of domestic market. Export of domestic medicine is actively done in emerging markets of South-east Asia. Among them, pharmaceutical market of Malaysia will grow up from 1.2 billion dollars in 2008 to 3.7 billion dollars in 2020 with local consumer’s self-medication tendency and aging society. To export the medicine, it is necessary to get permission and approval from target country and it seems that each country has different requirement in documents for introducing new drugs that developed in foreign country. We made charts comparing IND (Investigational New Drug) and NDA (New Drug Application) with Korea by searching the legislation and homepage of Malaysian Regulatory Agency and summarized the remarkable differences. We prepared the
objective and professional regulation plan to export domestic drug by discussing with pharmaceutical company and consulting company, domestic and abroad, which had experiences exporting their products in Malaysia.
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KEYWORD
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International market, Regulatory support, Malaysia, Export
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