中药中外源性有害残留物安全风险评估技术指导原则

中药中外源性有害残留物安全风险评估是科学、合理地控制中药外源性有害残留物风险的有效技术手段。为指导和规范中药外源性有害残留物的安全风险评估，本文提出评估技术指导原则。本技术指导原则从中药中外源性有害残留物安全风险评估的定义、相关术语以及风险评估的原则和基本程序等方面进行论述。探索并推行中药中外源性有害残留物安全风险评估技术体系，将为中药中外源性有害残留物的风险控制、残留限量标准的制修订提供有效的技术支撑，同时将对政府部门制定政策，应对突发药品安全事件，促进中药产业的可持续发展提供具有重要的实际意义。

Safety risk assessment of exogenous harmful residues in traditional Chinese medicine (TCM)is the effective technical approach to scientifically and reasonably control the risk of exogenous harmful residues in TCM. The purpose of the guideline is to guide and standardize the risk assessment of exogenous harmful residues of TCM. The topics of the technical guideline mainly include the definition of safety risk assessment of exogenous harmful residues in TCM,terms,principles and basic procedures of risk assessment. Exploring and implementing the safety risk assessment technical system of exogenous harmful residues in TCM will provide effective technical support for the risk control of exogenous harmful residues in TCM and for the revision of residue limit in standards. At the same time,it is of great practical significance for the government when formulating policies,dealing with unexpected drug safety incidents,and promoting the sustainable development of TCM industry.

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