LEXICON
No.113 May 11, 2012

(drug) Risk management plan (RMP)
医薬品リスク管理計画
Pharmacovigilance planning (PVP)
医薬品安全性監視計画
Risk minimization action plan (risk MAP)
リスク最小化活動計画

The Ministry of Health, Labor and Welfare (MHLW) will require submission of a risk management plan (RMP; 医薬品リスク管理計画) consisting of a pharmacovigilance plan (PVP; 医薬品安全性監視計画) and a risk minimization action plan (risk MAP; リスク最小化(活動)計画) for new drugs (新医薬品) and biosimilars...

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