加强我国国家药品标准规范化管理的思考

Reflection on Standardized Management of National Drug Standard in China

目的:为加强我国国家药品标准的规范化管理提供参考。方法:通过对辖区内各药品生产企业执行药品标准情况进行专项检查,结合平时监管发现的问题,进行综合性的分析、论证。结果:国家级药品标准太繁杂,其中存在的诸多问题,如药品标准管理的法律性和严肃性,国家有关政策文件与药品标准的规定的一致性,部分原、辅料的执行标准问题,使用的对照品、对照药材现行管理方式的规范性等,影响了管理和执行的规范化。结论:应制定严谨、完整、准确的国家药品标准,完善相关法律法规,以有效地督促企业建立规范化的药品标准档案,严格按照国家药品标准组织生产和检验。

OBJECTIVE：To provide reference for standardized management of national drug standard in China.METHODS：Special inspections about the implementation of national drug standard were performed in pharmaceutical manufacturers of Deyang area.Based on the results of daily inspections,national drug standard was analyzed and discussed comprehensively.RESULTS：National drug standards were too many and diverse so that they influenced standardized management and implementation,which involved several aspects such as legality and seriousness of the management of drug standard,the conformity of relevant policy with drug standard,the standard of raw material and excipients,standardization of management approach for reference sample.CONCLUSION：Rigorous,complete and accurate national drug standards should be formulated,and relevant laws and regulations should be improved.Pharmaceutical enterprises can be urged to establish standardized drug standard file and to organize production and testing in accordance with national drug standard.