日本藥品上市后風(fēng)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(xiàn)標(biāo)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(fēng)險管理計劃（RMP）的經(jīng)驗，為完善我國藥品上市后風(fēng)險管理提供參考。方法：介紹日本藥品上市后監(jiān)管的流程，剖析日本RMP中體現(xiàn)出的國際人用藥品注冊技術(shù)協(xié)調(diào)會（ICH）指導(dǎo)原則，研究日本RMP在藥品上市后安全管理中的制定與應(yīng)用，對我國藥品上市后風(fēng)險管理的完善方向提出建議。結(jié)果與結(jié)論：日本藥品上市后監(jiān)管具有動態(tài)監(jiān)管、社會共治的特點。ICH原則貫穿日本RMP管理，日本規(guī)定的安全性討論事項、風(fēng)險最小化活動等均體現(xiàn)了與ICH原則的內(nèi)在一致性。日本《藥事法》對RMP進行了規(guī)定，具體由日本藥品、化妝品及醫(yī)療器械的上市后安全管理的藥物警戒標(biāo)準(zhǔn)（GVP省令）指導(dǎo)制定和實施，由藥品上市后調(diào)查及試驗實施基準(zhǔn)的省令（GPSP省令）指導(dǎo)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(fù)責(zé)，而公眾可通過藥品和醫(yī)療器械綜合管理機構(gòu)（PMDA）訂閱媒體系統(tǒng)獲取新藥RMP，體現(xiàn)了政府-藥企-公眾多元共治。目前我國RMP監(jiān)管未成體系且經(jīng)驗不足，缺乏指南文件，信息通信技術(shù)應(yīng)用較少。建議我國加強上市后安全數(shù)據(jù)管理，推進哨點醫(yī)院與藥企藥物警戒系統(tǒng)相銜接，增加信息通信技術(shù)的應(yīng)用。國家藥品監(jiān)督管理局應(yīng)出臺相關(guān)規(guī)范性文件和RMP指南，明確藥品上市后監(jiān)管體系，以推行RMP公開為契機，促進藥品風(fēng)險管理社會共治，實現(xiàn)陽光監(jiān)管、科學(xué)監(jiān)管。

關(guān)鍵詞 風(fēng)險管理計劃;日本;國際人用藥品注冊技術(shù)協(xié)調(diào)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.