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KMID : 1142220220170020163
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Regulatory Research on Food, Drug & Cosmetic
2022 Volume.17 No. 2 p.163 ~ p.171
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Recommendations on Laws and Systems to Increase RWD/RWE Utilization in Regulatory Decision-making for Pharmaceuticals
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Ha Min-Young
Lee Ji-Yeon
Kwa Mee-Song
Kim Song-Hee
Sung Hi-Gin
Park Sung-Min
Jang Jin-Won
Shin Ju-Young
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Abstract
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With the development of big data collection and analysis technology, Big data utilization using RWD(Real- World Data) and RWE(Real-World Evidence) is increasing in the healthcare field, and it is being applied not only to post-marketing safety management but also to the entire drug development cycle. However, since the issue of data collection and utilization and personal information protection regarding RWD/RWE utilization continues to be mentioned, the need for institutional overhaul of the regulatory authorities for the RWD/RWE utilization in the domestic pharmaceutical sector has been raised. Accordingly, we would like to proceed with the development of a system related to the use of RWD/RWE in domestic pharmaceuticals, referring to the system related to RWD/ RWE overseas. In the United States, the quality and acceptability of RWE can be improved through the 21st Century Cures Act and PDUFA, and sensitive information utilization measures can be confirmed through HIPAA. In Europe, the Personal Information Protection Act can be confirmed through the GDPR, Data utilization and access legislation can be checked through A European strategy, EMA Network strategy and HMA-EMA Bigdata taskforce for data. In Japan, anonymous processed information was introduced through the revision of the Personal Information Protection Act, and the system related to the use of RWD/RWE can be confirmed through the revision of GPSP and 次世代?療基盤法. As a result, Domestic laws need to be revised by preparing specific laws, reviewing data sharing and utilization plan revisions reflecting data altruism, and expanding the scope of database research after marketing. In this study, referring to relevant laws and initiatives for RWD/RWE utilization in the US, Europe, and Japan, the RWD/RWE utilization system in the domestic pharmaceutical and medical device industries is established, and new policies are introduced and revised.
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KEYWORD
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Health and Medical field, RWD(Real-World Data), RWE(Real-World Evidence), Big Data Utilization, laws and system
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