（Reference）

FDA关于风险减低行动计划实施与发展的指导：http：/ / www . fda . gov/ohrms/dockets/ac / 05 / briefing / 2005-4136 b1 _ 03 _ Risk%20Minimization%20Action%20Plans . pdf.Ronald D . Mann，Elizabeth B . Andrews . Phamacovigilance . 2nd ed .13 .药物警戒管理规范：http：/ / www . ema . europa . eu/ema/index . jsp？Curl = pages/regulation / document _ listing/document_listing_000345 . jsp& .Murl = menus / regulations/regulations . jsp& .