以“风险控制”为核心推进中药质量安全标准建设

Promoting the Standard Construction of Quality and Safety of Traditional Chinese Medicine with Risk Control as the Core

针对中药中外源性有害物质的监管,本文提出了以风险控制理论指导中药中外源性有害残留物标准建设,建立符合中药使用特点的风险评估技术体系。同时,应尽快建立有害成分及污染物数据库,通过风险评估,明确高风险点,完善检测方法和限量标准。以《中国药典》为核心的不同标准体系间要高效互补,有效协调,降低政策风险。

For the supervision of exogenous harmful residues in Traditional Chinese Medicines （TCMs）, it is pro- posed to guide the standards construction of exogenous harmful residues in TCMs by the risk control theory and to establish a risk assessment technology system conforming to the using characteristics of TCMs. Meanwhile, a data- base of harmful components and pollutants should be established as soon as possible. The clear high risk points should be identified by the risk assessment, and the test methods and limit criteria also should be improved. The different standard systems with Chinese Pharmacopoeia as the core should be highly complementary and effectively coordinated to reduce the risk of policy.