Research On Drug Official Supervision In Heilongjiang Province Based On Total Quality Management

Drug, which has a close relationship with people’s physical health and life security, is a special commodity. Nowadays, pharmaceutical market is more complicated and diverse and how to guarantee the drug safety for the common people become a problem to which many countries pay attention. For the drug safety, developed countries has a strict drug supervision and heavily blows on illegal behavior on drug safety. Although drug safety supervision is emphasized in the developing China, the supervision level is still on the early step. Compared with the supervision level in developed countries, drug supervision in China has some problems, such as only supervision after drug affairs, low technology application during supervision and little participation of common people. So drug safety cases occur frequently with the rapid development of the pharmaceutical industry. People’s health is threatened by illegal, fake drugs and drugs of poor quality. Above problems are presented in Heilongjiang province, which plans to build to be drug valley in the north China. Although some leading well-known enterprises, such as Hayaoplay a leading role on drug research and manufacture in Heilongjiang province and the whole China, some cases, for example," Qieryao","Hegang jumbo JiaYao An"^happened in Heilongjiang exert bad effect on drug manufacture for Heilongjiang. Therefore, drug supervision in Heilongjiang province is reflected by repeatedly emergence of fake and inferior drugs, poor original innovation, and disordered competition between medical enterprise, and so on. Facing to the problems and challenges, Heilongjiang province drug regulators should change supervision idea, the innovation way of supervision and regulation, improve supervision measures and supervision level comprehensively.This thesis firstly clarifies the basic theory from the total quality management theory and drug supervision theory respectively. Then the drug supervising circum stances of Heilongjiang province is researched by some aspects respectively, such as subject, object, methods and steps, from which series main problems analysis by investigation method. These problems include scattered drug regulators, uneven quality of drug supervision team, weak consciousness of the drug supervision officers, scattered drug supervision object, serious enterprise homogenization, imbalance drug quality supervision between urban and rural area, loss of the prevention regulatory mode, less development on supervision process technology and little public participation, etc. Then experiences of total quality management thoughts, applied on drug supervision in several developed countries are analyzes developed countries. Our Beijing specific will total quality management standardization ISO9000import drug supervision and the practice of Shanghai pharmaceutical supervision of comprehensive management mode, through reference to the domestic and foreign relevant experience and enlightenment. And then drug administration supervision frame work in Heilongjiang province is constructed by applying total quality management. Finally this framework application in Shuangyashan city is practically analysis, and some specific countermeasures on quality local drug supervision improvement is proposaled.