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KMID : 1022920210090010014
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Journal of Korean Academy of Social & Managed Care Pharmacy
2021 Volume.9 No. 1 p.14 ~ p.20
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Development Safety Update Report(DSUR): Focusing on International Council of Harmonization(ICH) guideline E2F and the systems of U.S., EU and Japan
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Park Sun-Je
Shim Da-Young
Park Sang-Jun
Rhee Ha-Eun
Shin Ju-Young
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Abstract
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The Development Safety Update Report(DSUR) is the periodic safety report on drugs under clinical trials( including marketed drugs that are under further study). The main objective of a DSUR is to present a comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period. The guidelines of International Council of Harmonization(ICH) play a standard role in pharmaceutical industries among the ICH regions(including U.S., EU and Japan) and in the case of DSUR, ICH guidelines E2F(ICH E2F) works as a standard. Those countries above(U.S., EU and Japan) already establish DSUR systems based on ICH E2F and in South Korea, Ministry of Food and Drug Safety(MFDS) is planned to implement the DSUR and make the submission mandatory gradually from 2021 to 2024. So in this report, with the implementation of the DSUR ahead off, we first reviewed ICH E2F guideline and compared with the DSUR systems of U.S., EU and Japan, then we discuss current situation and implication in South Korea including specific plan, legislation and advantages it would offer.
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KEYWORD
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Clinical Trials, ICH E2F, Development Safety Update Report, DSUR
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