浅谈化学药品新药试行标准转正工作的体会

目的探讨药品标准分类及管理情况,为顺利完成化学药品新药试行标准转正工作提供参考。方法总结我国药品标准分类的历史沿革,阐明化学药品新药试行标准转正工作的背景和意义。分析了化学药品新药试行标准转正工作涉及的各种情况,包括：已经收载于《中国药典》的品种;已有新国标的品种;经过修订提高标准的品种;部分厂家已有国标的品种和未有国标品种的处理原则。结果与结论通过药品标准转正工作,药品标准的标准化管理优势将进一步得到体现,但暂时未能彻底解决统一药品标准的问题,在一定时间内,还存在着同一品种不同标准的局面。国家相关部门应持续开展药品标准提高修订与统一工作,形成健全的药品标准体系,为药品生产企业创建公平的市场竞争环境,以药品质量的提高确保人民用药的安全有效。

Understanding of Regularization of the Tentative Standard for New Chemical Medicines

Objective To discuss classification and management of drug standards and provide a reference for regularization of the tentative standard of new chemical medicines.Methods The evolution history of drug standard classification in our country was summarized.The background and significance of regularization of the tentative standard of new chemical medicines were clarified.The various situations involved in regularization of the tentative standard of new chemical medicines were analyzed,including drugs recorded in China Pharmacopoeia,drugs with new existing national standards,drugs with revised and improved standards,drugs with existing national standards produced by certain manufacturers and management principles for drugs with no national standards.Results and Conclusion Through the regularization work for the tentative standard,standardization management advantages will be further reflected,but for the moment,the problem of disunity of standards has not yet been completely solved and there exist different standards for one same variety.Relevant departments of the government should constantly carry out the work of standard unification and improvement to form a sound system of drug standards,thus to create a fair market competition environment for drug production enterprises and ensure the safety and effectiveness of drugs with the improvement of drug quality.