中药注射剂的安全性研究与评价

Safety Research and Assessment of Injections of Traditional Chinese Medicine

本文分析了中药注射剂不良反应的现状和原因,提出要积极打造高水平中药安全性研究与评价平台;要重视中药的规范监管,从源头保证中药注射剂的质量,在GLP条件下评价产品的安全性和有效性。并建议国家应加大支持力度和技术指导,强制实施非临床安全性评价,尽快完善药品上市后再评价体系,确保人民用药安全。

This article analyses the circumstance and causes of adverse reaction of injections of traditional Chinese medicine, and brings forth construction of a platform of advanced safety research of traditional Chinese medicine;Administration of traditional Chinese medicines should be emphasized, and the quality should be assured from source. The assessment of safety and efficacy of products should be performed under the condition of GLP. The article suggests that SFDA enhance support and technical guidance, enforce the proceeding of non-clinical safety assessment, and consummate the system of reassessment of drugs after marketing, securing the safety of usage of drugs.