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KMID : 1142220150100020155
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Regulatory Research on Food, Drug & Cosmetic
2015 Volume.10 No. 2 p.155 ~ p.164
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Risk Management Plan (RMP) of Japan
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Oh Eun-Young
Choi Kyoung-Ah
Yang Hyun-Ju
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Abstract
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Korea started to implement the regulation to submit Risk Management Plan(RMP) on the products of new drugs, orphan drugs and others designated by the head of Ministry of Food and Drug Safety(MFDS), from 1st July 2015. Beforehand, US established and implemented Risk Evaluation & Mitigation Strategy(REMS), and EU and Japan introduced(RMP). Especially for Japan which has similar safety related regulations such as reexamination and re-evaluation to Korea started RMP 2 years earlier than Korea. So, implementation status in Japan can be referred to Korea. Here we will overview general regulation on RMP, implementation status and some activities of several stakeholders like industries and associations prior and post RMP implementation, through this article. In total, 85 RMPs are submitted and enacted until April 2015 from April 2013, but it may be too short to assess its effectiveness. For the safe and efficient launch and development of RMP system, it will need to examine and improve various efforts among industries, regulatory agencies and professionals, and to adopt successful cases of other countries.
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KEYWORD
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Risk management plan, RMP, Japan
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