Abstract:In order to ensure safety and efficacy of Yueanxin Kudiezi Injection (referred to as KDI) we launched a comprehensive research ranging from production, quality control, pharmacology, to post- market safety evaluation etc. The results showed KDI was strictly QC’ed from GAP to the production process. No adverse reaction was shown in acute toxicity test, long-term toxicity test, and phase III clinical study for treatment of coronary heart disease and cerebral thrombosis; KDI was approved to be effective and safe in a randomized, double-blind, positive controlled, multi center clinical trials for treatment of coronary disease angina pectoris (blood stasis syndrome) and stroke (cerebral infarction); 691 cases reported in SRS, PRR method and BCPNN method displayed, headache is warning signal of ADR; Our research results provided safety information of KDI for clinical use, scientific research and production.