Abstract: With the increasing adverse events of traditional Chinese medicine injection, its safety problem arouses the social's concern, therefore it's necessary for traditional Chinese medicine injection(TCMI) enterprises to perform quality risk management. This article took the experience of an enterprise as example, introduced to TCMI enterprises how to establish risk management system under the recommendation procedure in ICH Guideline Q9, to achieve the purposes of minimizing risks and ensuring quality and safety of drugs.

Key words: traditional Chinese medicine injection, risk management system, risk assessment, risk control