从缺陷产品角度评我国现有的中成药标准

Review on the Existing Chinese Medicine Standards in China from the Perspective of Defective Product

我国法律将"产品缺陷"定义为"不合理的危险"。按照药品的特点,缺乏系统的有效性、安全性评价,不具有相应功能(适应症)的药品即可能被认为存在缺陷。以此为视角,我国现有的中成药标准就存在诸多构成产品缺陷的因素:上市前未进行过系统的安全性、有效性评价;上市后缺乏再评价;评价标准在变化;同一药品不同剂型品种之间的一致性缺乏依据;同一成分作为标准控制项目降低了药品标准对质量识别的作用;用药原则难以实现;药品说明书存在警示缺陷、对临床的实际指导有限;存在安全与质量隐患。

In China, ＂product defect＂ is defined as ＂unreasonable danger＂ legally. According to the characteristics of drugs, when drugs lack the evaluation of the effectiveness and safety, and do not have the corresponding function （indications）, they may be considered defective. Based on this perspective, there are many factors in the existing Chinese medicine standards which may lead to product defects in our country, namely no systematic evaluation of its effectiveness changing evaluation standard; and safety before selling in the market; the lack the lack of consistency among varieties of dosage of re-evaluation after selling; the of the same drug; as the standard control project, the same ingredient＇s reduction in the effect of drug standards on quality recognition; the difficulties in achieving drug use principle; the lack of warning defects in the package inserts of drugs; the limit practical guidance to clinic; and the hidden safety and quality troubles, etc..