日本藥品上市后風險管理計劃研究及對我國的啟示

賈國舒 梁毅

中圖分類號 R951 文獻標志碼 A 文章編號 1001-0408（2021）19-2305-09

DOI 10.6039/j.issn.1001-0408.2021.19.01

摘 要 目的：借鑒日本藥品上市后風險管理計劃（RMP）的經驗，為完善我國藥品上市后風險管理提供參考。方法：介紹日本藥品上市后監管的流程，剖析日本RMP中體現出的國際人用藥品注冊技術協調會（ICH）指導原則，研究日本RMP在藥品上市后安全管理中的制定與應用，對我國藥品上市后風險管理的完善方向提出建議。結果與結論：日本藥品上市后監管具有動態監管、社會共治的特點。ICH原則貫穿日本RMP管理，日本規定的安全性討論事項、風險最小化活動等均體現了與ICH原則的內在一致性。日本《藥事法》對RMP進行了規定，具體由日本藥品、化妝品及醫療器械的上市后安全管理的藥物警戒標準（GVP省令）指導制定和實施，由藥品上市后調查及試驗實施基準的省令（GPSP省令）指導變更。RMP是日本新藥上市注冊及再審查的必要文件，藥企對制定RMP負責，而公眾可通過藥品和醫療器械綜合管理機構（PMDA）訂閱媒體系統獲取新藥RMP，體現了政府-藥企-公眾多元共治。目前我國RMP監管未成體系且經驗不足，缺乏指南文件，信息通信技術應用較少。建議我國加強上市后安全數據管理，推進哨點醫院與藥企藥物警戒系統相銜接，增加信息通信技術的應用。國家藥品監督管理局應出臺相關規范性文件和RMP指南，明確藥品上市后監管體系，以推行RMP公開為契機，促進藥品風險管理社會共治，實現陽光監管、科學監管。

關鍵詞 風險管理計劃;日本;國際人用藥品注冊技術協調會;藥物警戒;上市后研究

Study on Post-marketing Drug Risk Management Plan in Japan and Its Enlightenment to China

JIA Guoshu，LIANG Yi（School of International Pharmaceutical Business，China Pharmaceutical University，Nanjing 211198， China）

ABSTRACT ? OBJECTIVE： To provide reference for improving the post-marketing drug risk management in China by refering to the experience of post-marketing drug risk management plan （RMP） in Japan. METHODS：The process of post-marketing drug regulation in Japan was introduced， and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use （ICH） guidelines embodied in RMP in Japan were analyzed. The formulation and application of RMP in Japan during the post-marketing safety management were studied. And suggestions were offered for the improvement of post-marketing drug risk management in China. RESULTS & CONCLUSIONS： The post-marketing regulation of drugs in Japan is characterized with dynamic regulation and social co-governance. ICH principle runs through the RMP management in Japan. Safety specification and risk minimization activities stipulated in RMP in Japan are consistent with ICH guidelines. RMP is defined in Pharmaceutical Affairs Law in Japan， and is formulated and implemented under the guidance of the Good Vigilance Practice; the changes are made under the guidance of the Good Post-marketing Study Practice. RMP is a necessary document for the registration and the re-review of new drugs in Japan， its formulation is responsible by pharmaceutical enterprise; RMP of new drug is available to the public through the subscription media system of Pharmaceuticals and Medical Devices Agency （PMDA）， which reflects the multi-governance of the government-pharmaceutical enterprises-the public. In China， RMP supervision is not systematic and is inexperienced， and there is a lack of guidance documents and insufficient application of information and communication technology. It is suggested that China should strengthen post-marketing safety data management， promote the connection between sentinel hospitals and pharmacovigilance systems of pharmaceutical enterprise， increase the application of information and communication technology. Relevant normative documents and guidance documents of RMP should be issued by National Medical Products Administration. And the post-marketing supervision system for drugs should be clarified. ?Taking RMP publicity as an opportunity promote drug risk mamagement co-government， realize sunshine and scientific supervision.