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KMID : 1142220210160010049
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Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 1 p.49 ~ p.54
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Regulatory System of Human Medicines in European Union
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Weon Kwon-Yeon
Lim Hwa-Kyung
Song Yun-Kyoung
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Abstract
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The aim of this study was to collect information on the EU's drug approval/examination process, and based on this, to analyze the differences in the drug licensing regulatory system between the Korean Food and Drug Administration and the European EMA. To this end, information on clinical trial plan approval application, new drug approval application, generic drug approval application, renewal, pharmacovigilance, and fee information was systematically organized through the analysis of related laws, regulations, guidelines and literature on the EMA website. The European drug authorization procedure is divided into an integrated procedure, a decentralized procedure, a mutual recognition procedure, and a national authorization procedure. There were differences in the procedure and review period when applying for a new drug between the Korean Food and Drug Administration and the European EMA, and in Europe, it was required to submit a pediatric drug development plan when applying for a new drug license. There was also a difference in the pharmacovigilance system between the Korean Food and Drug Administration and the European EMA, and fees were set about 60 times higher in European EMA than in Korea. The results of this study, which analyzed the European EMA's drug approval review system, are expected to contribute to a better understanding of the European EMA's drug approval review system and to seek ways to harmonize the regulation of the domestic drug approval review system.
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KEYWORD
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European Union, Human medicine, Regulatory System
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