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目的:探讨药品生产企业在《药品不良反应报告和监测管理办法》(新《办法》)下顺利开展ADR监测工作的模式。方法:通过对新《办法》解读、现状及制约因素分析,探索生产企业ADR监测工作开展模式。结果与结论:生产企业在短期内一步到位完全按照新《办法》要求开展ADR监测工作与现状跨度较大,可以通过一“平台”四“拓展”的模式,分块逐步突破,开展ADR监测工作,最终完全达到新《办法》的要求,履行主体地位的责任和使命。
Objective: To explore the mode of smoothly carrying out ADR monitoring work under the “Measures for the Administration of Adverse Drug Reaction Reporting and Monitoring” (the “new approach”) by pharmaceutical manufacturers. Methods: By analyzing the new “Measures”, the status quo and analysis of constraints, explore the development mode of ADR monitoring work in manufacturing enterprises. RESULTS AND CONCLUSION: The production enterprises in a short period of one step in full accordance with the requirements of the new “measures” to carry out ADR monitoring work and the status quo span a larger, through a “platform ” four “expansion ” model, ADR monitoring work, and ultimately fully meet the requirements of the new “Measures” to fulfill the responsibility and mission of the dominant position.