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KMID : 1142220220170010037
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Regulatory Research on Food, Drug & Cosmetic
2022 Volume.17 No. 1 p.37 ~ p.43
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Comparative Analysis of Clinical Trials and Drug Review Systems for Pediatrics
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Song Yun-Kyoung
Oh Jung-Mi
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Abstract
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This study was aimed to analyze and compare the regulatory systems of clinical trials and drug review for pediatrics among the United States, the European Union, and Korea. The organizations, laws, guidelines and policies related to drug safety for pediatrics was analyzed using the homepages of the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). There are independent organizations for strengthening the safety management of pediatric drugs such as the US FDA, Office of Pediatric Therapeutics, and the EMA, the Pediatric Committee, but there is no relevant organization in Korea. In addition, since the 1990s, the US FDA has been revitalizing clinical trials for children and providing incentives for pediatric drugs through Pediatric Legislation such as BPCA, PREA, FDAAA, and FDASIA and federal regulations, which was reflected in drug review for pediatrics. In the EMA, the Pediatric Regulation in 2007 made it mandatory to submit a pediatric research plan for drug approval, thereby activating clinical trials. Therefore, in Korea, the Ministry of Food and Drug Safety needs to prepare systems and policies to strengthen the safety protection of pediatric drugs, strengthens support for pediatric clinical trials, establishes related industry-university-related research cooperation networks, and support pediatric clinical trials for domestic pharmaceutical companies. In addition, it is necessary to strengthen the public education on clinical trials and safe use of the medicines for pediatrics and their parents.
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KEYWORD
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Pediatric, Clinical Trial, Drug Review, Safety
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