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军队医疗机构制剂标准提高计划实施构想
引用本文:陈征宇,孔爱英. 军队医疗机构制剂标准提高计划实施构想[J]. 中国药事, 2013, 0(11): 1157-1160
作者姓名:陈征宇  孔爱英
作者单位:[1]总后卫生部药品器材局,北京100842 [2]总后卫生部药品仪器检验所,北京100842
摘    要:目的阐述实施"军队制剂标准提高计划"的必要性,此计划有利于推动全军医疗机构制剂质量标准提高、准入和退出长效机制的形成。方法总结历版《中国人民解放军医疗机构制剂规范》(以下简称《军规》)的修订情况,分析当前国家药品标准提高现状和现版《军规》存在的问题,论述标准提高计划的整体思路和步骤。结果与结论随着标准提高计划的实施,以课题形式部署在机制上是个创新,对健全法律法规、促进药学多专业建设、质量标准评估机制的初步建立及制剂标准的动态化管理等方面有积极的推进作用,"军队制剂标准提高计划"的全面实施,对于保证军民用药安全有效具有深远意义。

关 键 词:军队医疗机构制剂标准提高计划  军队医疗机构制剂规范  质量标准评估机制  动态化管理  再评价

An overall Ideas on Launching the Enhancing Program of Military Hospital Prepared Medicine
Chen Zhengyu and Kong Aiying. An overall Ideas on Launching the Enhancing Program of Military Hospital Prepared Medicine[J]. Chinese Pharmaceutical Affairs, 2013, 0(11): 1157-1160
Authors:Chen Zhengyu and Kong Aiying
Affiliation:Chen Zhengyu and Kong Aiying (Drug and Medical Equipment Administration Bureau of Health Department, Beijing 100842;1Drug and Medical Equipment Inspection Institute of Health Department)
Abstract:Objective To explain the necessity of implementing the Enhancing Program of Military Hospital Prepared Medicine which is help-ful for setting up a long-term mechanism of military prepared medicine quality standard update, admittance and withdrawal. Methods Through summarizing versions of Technical Standard of Military Hospital Prepared Medicine, the state drug standards and the problems of the current version of Technical Standard of Military Hospital Prepared Medicine were analyzed, and the overall ideas and the procedure of the Enhancing Program were discussed. Results and Conclusion With the implementation of the Enhancing Program, an innovation in mechanism was made with deployment of projects, which will positively push the preference of laws and regulations the construction of multi- pharmaceutical specialty the preliminary establishment of the quality standard evaluation mechanism and the dynamic administration of hospital prepared medicine, the program is of profound significance meaning to safeguard the patients' drug safety use.
Keywords:the Enhancing Program of Military Hospital Prepared Medicine  technical standard of military hospital prepared medicine  quality standard evaluation mechanism  dynamic administration  revaluation
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