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KMID : 0370220130570030173
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Yakhak Hoeji
2013 Volume.57 No. 3 p.173 ~ p.186
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A Study on Improving Korea’s Regulatory System for Pharmaceutical Safety Management
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Chae Gyu-Han
Cho Gi-Won
Nagata Ryuji
Park Ji-Sun
Hong Chong-Hui
Kang Jong-Seong
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Abstract
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To ensure the safe use of pharmaceuticals in the market, US, EU and Japan reached a consensus to adopt ICH harmonised tripartite guideline "E2E Pharmacovigilance Planning" in 2004. Subsequently these regions established and implemented new pharmaceutical safety management systems for patients based on ICH E2E guideline and Risk Evaluation and Mitigation Strategy (REMS) in US or Risk Management Plan (RMP) in EU and Japan. In this study we investigated these new foreign systems and suggested a way to improve Korea’s regulatory system for pharmaceutical safety management under Korea Pharmaceutical Law in the view of international harmonization.
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KEYWORD
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pharmacovigilance, Risk Evaluation and Mitigation Strategy (REMS), Risk Management Plan (RMP), risk communication, MFDS
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