基于全生命周期视角的国家药品标准管理思考

Reflection on National Drug Standards Management from the Perspective of Whole Lifecycle

关键词:  生命周期  国家药品标准  管理  建议

Key words:  lifecycle  national drug standards  management  recommendations

摘要:

目的 为国家药品标准管理提供参考。方法 通过查阅文献，访谈药品标准领域专家，结合药品标准管理工作实践，运用生命周期理论对国家药品标准生命周期进行阶段划分，总结各阶段特点，并提出相应的管理建议。结果 国家药品标准生命周期可以划分为标准规划、标准制定和修订、标准贯彻实施和信息反馈4个阶段。针对标准规划科学、前瞻和可操作的特点，提出应当紧密结合我国医药行业发展现状、临床用药以及药品监管需要，全面收集药品标准需求，制定可操作且具有前瞻性药品标准规划的建议。针对标准制定和修订周期长，参与标准研究单位多，时间紧特点，提出应当遴选高水平研究单位参与标准制定和修订工作，并做好课题督导和绩效考核的建议。针对标准贯彻实施和信息反馈实践性强、信息量大、反馈意见急等特点，提出应当通过制定制度，将合理的反馈意见及时转化为标准或者标准研究课题的建议。结论 基于生命周期理论识别的国家药品标准各阶段特点可以为国家药品标准实践管理提供理论借鉴，有利于更全面、更系统地制定相应阶段应采取的策略。

Abstract:

OBJECTIVE To provide references for the management of the national drug standards. METHODS Through looking up the literatures, interviewing the experts in the field of drug standards and combining with the practice in drug standard management, the national drug standards were divided into different stages by using lifecycle theory, the characteristics of every stage were summed up and the corresponding management advice were put forward. RESULTS The national drug standards lifecycle was divided into four stages, including standards planning, standards establishment and revision, standards implementation and standards information feedback. Based on the scientific, forward-looking and operational characteristics of the standards planning, combined with the present situation in pharmaceutical industry development in China, clinical medicine and drug regulatory needs, collecting comprehensive pharmaceutical standards requirements and formulating operational and proactive standards planning are advised. For the long cycle of formulating and revising standards, a number of units participated in the research of standards and the time was limited, selecting high-level researching units involved in formulating and revising standards, strengthing the supervision and making performance evaluation should be proposed. In view of the practical, informative and urgent characteristic in national drug standards implementation and feedback, establishing the procedures and converting the reasonable feedbacks to standards or researching projects timely were proposed. CONCLUSION The characteristics of each stage of the national drug standard based on the life cycle theory can provide theoretical references for the practical management of the national drug standard, which is conducive to the formulation of strategies more comprehensive and systematic.