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KMID : 1142220180130010025
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Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 1 p.25 ~ p.33
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Vietnam Regulatory System : How to Register Domestic Drug in Vietnam
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Min Kyoung-Rok
Kwon Jin-Won
Lee Eui-Kyung
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Abstract
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As the global pharmaceutical market continues to grow due to aging population and chronic diseases, the emergence of the ‘Pharmerging’ countries, which mainly contributed by rapid economic growth and improvements in medical services, have become prominent. At the same time, Korea's drug market growth rate has slowed down. Domestic pharmaceutical companies need to establish strategies aimed at overseas markets rather than domestic ones. Among the ‘Pharmerging’ countries, Vietnam has emerged as an attractive target for korean pharmaceutical companies seeking countries with both rapidly growing pharmaceutical market and sustained growth rate. This research analyzes Vietnam's regulatory system by studying the relevant laws and opinions of experts to promote the export of domestic pharmaceutical companies. The drug registration documents in Vietnam use the ASEAN Common Technical Document format (ASEAN CTD) as part of the regulatory harmonization with neighboring countries. In addition, generic drugs require only module 1 and module 2 of ASEAN CTD. However, when using certain active ingredients designated by the Ministry of Health, it is necessary to conduct bioequivalence test and submit its results. Drug manufacturers in overseas are required to qualify at least WHO-GMP (WHO Good Manufacturing Practice). Vietnam used to require ASEAN-GMP, but currently all the local manufacturers in Vietnam are also required to qualify WHO-GMP. In addition, because of the geographical characteristics of Vietnam with high temperature and high humidity, stability test data carried out in the Climatic Zone IVb are required. In the public bidding of generic medicines, Vietnam gives grades according to the pharmaceutical manufacturer's manufacturing level, the higher the grade, the more the preferential bidding can be. As there are many positive factors like the increase in the bid rating of many domestic pharmaceutical companies due to the effect of PIC/S subscription in Korea, a sufficient understanding of Vietnamese regulations will help to foster exporting activities.
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KEYWORD
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vietnam, approval application, regulatory system, new drug, generic
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