Thoughts on the Related Issues of Hypersensitivity Evaluation and Risk Control of Traditional Chinese Medicine Injection

Reevaluation of traditional Chinese medicine injections (TCMI) has not made substantial progress over the last more than ten years since 2009 due to the difficulties of management and the lack of right methodology. This paper analyses the common concerns on the characteristics and nature of adverse reactions of TCMI, and the current problem with the methods of preclinical safety evaluation. The authors also introduce their researches on hypersensitivity characteristics, the new methods on safety evaluation and risk control of TCMI in the hope of providing reference for the institutions and enterprises in the safety reevaluation of TCMI.