The Countermeasures Research For Enforcing Pharmacovigilance Of Traditional Chinese Medicine Injection

It's well-known that drugs have two kinds of inherent properties-therapeutic action and side effect.And the essence of pharmacovigilance is to safeguard the public's medication safety. As the pioneer of TCM modernization,TCMI provides a new choice for treating illness in imminent and severe states and patients unfit for oral administration in TCM clinical with its advantages such as accurate-dose,rapid-efficacy and high-bioavailability.The theoretical research is divided into two parts.The first part is pharmacovigilance theory research.Firstly discuss the concept,object,scope,purpose and meaning of pharmacovigilance. Then analyze the present pharmacovigilance situations from home and abroad,such as the WHO International Drug Monitoring Program,the EU pharmacovigilance system,the United States pharmacovigilance system and the pharmacovigilance status in China.Lastly introduce Chinese Traditional pharmacovigilance theory and its practical significance.The second part is TCMI theory research.Starting from the concept of TCMI,educe the development situations,and using principles.Then from composition,preparation technology,quality standard and the functions make an overall analysis on TCMI.The applied research is also divided into two parts.The first one is the safety analysis of TCMI.Firstly,analyze the current safety status of TCMI.Then analyze factors which influence safety of TCMI from the process of production,circulation fields and use terminal.The second one is countermeasures for enforcing pharmacovigilance of TCMI.Be emphasized to explore some countermeasures or proposes for carrying pharmacovigilance of TCMI into execution in terms of the pharmaceutical enterprises,the competent authority and medical institutions.