YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

A Study on Improving Korea's Regulatory System for Pharmaceutical Safety Management

의약품 안전성 관리를 위한 연구 - 의약품 안전관리 제도개선 방안을 중심으로 -

  • Received : 2012.07.03
  • Accepted : 2013.06.17
  • Published : 2013.06.30
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Abstract

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.

Keywords

References

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