Study On The Current Status And Policy Of The Adverse Drug Reaction Monitoring System

In 1961, the event, which is now considered as “the biggest drug catastrophe ever since the 20 th century” and “Thalidomide”,shocked the whole world and the adverse drug reaction was paid highly attention all over the world. Recently, more and more drug events such as the “Qiqihar second pharmaceutical”, “Clindamycin Phosphate Glucose Injection”,“ Senticosus injection” and the " Gentiana pill Event", together with the event”Nimesulide, NIM” reported by the 2010 Children Drug Safety International Forum, have drawn more and more public’s attention on the supervision on the adverse drug reaction.We are very sorry for the hurt even the death of people involved in the drug events. Their miserable experiences are just like buckets of ice water poured on everybody’s head, like some sharp swords cut in everybody’s heart. Therefore, the better improvements of the supervision on the adverse drug reaction are now in urgent need in order to meet the public’s drug use safety needs and make sure that the development of the supervision on the adverse drug reaction will be carried out correctly and orderly.This thesis is based on the basic concept of the drug and the adverse drug reaction.Being aware of the concept, kinds and features of the adverse drug reaction, it analyzes the present situation of our country’s supervision on the adverse drug reaction and the policy development. This thesis is consisted of six parts. The first part is the concept of the adverse drug reaction and some related basic introduction, features and analyses. The first part also talks about the research purpose and meaning of this topic and its history and present situation. And the research schemes and technology routes of this topic. The second part is the current statements, analyses and references of foreign supervision on the adverse drug reaction. The third part is the current situation in the monitoring system of adverse drug reaction in China. The fourth part is the current problems and analyses about the supervision on the adverse drug reaction in China. The fifth part is the obstacles of the Chinese adverse drug reaction supervision and the attempts of foreign advanced ideas. The fifth part also talks about some suggestions and ways to deal with the policy. The sixth part is the conclusion of this topic.The purpose and meaning of this thesis lies in: First, I hope this thesis can help the drug production enterprises, the drug organizations and the drug selling companies pay more attention and restrain the drug abuse. Next, I hope this thesis can give some guidance to drug supervisors, consumers even the victims suffering from the adverse drug reaction.At last, I hope this thesis can give some valuable references to the National Food and Drug Administration or follow-up researchers in order to make the supervising policy of the Chinese adverse drug reaction better and better.