| The drugs are the valuable cargo which uses in preventing disease, treating an illness, Drug quality problems are closely related to the people's life and health, and How to complete the drugs quality supervision work become very important。In recent years, our country presented " qi er yao"," xin fu" and other important drug quality problems, have caused the serious harm for the majority of patients, and resulted in a very far-reaching social impact. How to grasp the drug regulatory laws, improve the ways, enhance degree of security has its practical significance and long-term significance.This paper take Beijing Shunyi District 2002-2009 year drugs quality case as a foundation, from the perspective of drug regulation, through the search for literature, read the supervision of the case file, to sort out the data, using theoretical analysis and case analysis method, from the public health management science, economics, medicine, social psychology, points of view in-depth research and analysis, and strive to find scientific and objective cases occurred in drug laws, drug supervision work demonstrated the gains and losses, to seek to solve drug regulation in the emphasis and difficulty.This paper first has carried on the analysis to the drugs quality case quantity's development's tendency, finally founded that from 2002 onwards, the number of cases occurred overall downward trend, with its correspondingly, the pharmaceutical market testing pass rate gradually stabilize and maintain at a high level, but subject to various factors, drug quality cases there is still a certain extent, drug monitoring is still very difficult. During 8 years, the cases without qualification categories have been taking more than 50%,and becoming "the malignant tumor" in the drugs supervision, the illegal propaganda, deceives the populace, to walk randomly decides, the escape supervision is its major feature; The quality of the case arose under the drug found that more than 70% of the cases reported from society, not only the community response to drug quality and safety awareness-raising, but also an objective that the vast numbers of social forces is an important force in drug regulation, administrative law enforcement departments should continue to flow "Social Report of the door" for drug quality control services, we must also strengthen their own initiative to detect and prevent cases of drug quality capacity; Study foundthat the network in recent years, cases of fake drugs sold by mail order from scratch, from small to multi-, and rapid growth, from the number already quietly grown into the most important categories of cases of drug quality, and we must attach great importance to drug regulatory authorities and vigilance; From the composition of the number of the incident's happening, in the availability of legal qualification of "drug related" units, the number of pharmaceutical enterprises ranked first in incidence, it was partly due to procurement of medicines and multi-channel chaos led to counterfeit and inferior quality drugs, part of the imperfect for a variety of business records, etc. have been punished, competition in the market leading drug retailers continue to reduce costs, incidence of poor self-discipline to become deep-seated reasons; The number of cases of medical units came in second place, and all the more serious nature of the quality of cases of counterfeit drugs. Medical units pharmaceutical quality control law is not perfect, Medicine practitioners lack access to compliance lack of systematic quality control norms are the main reason for its weak drug regulation; From the incidence geographical perspective, the countryside is a veritable "injury of the" hardest hit, farmers have become the main victims of drug quality, not only its economic status, educational level, self-protection awareness related to the uneven distribution of medical resources, medical practitioners in rural areas of pharmaceutical quality management level is not high, has also become an important reason.In this paper, based on the reality of China's drug supervision, Through the reaction of various figures of the status and trends of in-depth analysis and demonstration, Made the following regulatory proposals:We should attach great importance to the quality of supervision of drug, Drug regulatory authorities should always be vigilant, Continue to strengthen drug regulatory sense of crisis; Drug Administration should focus on the daily supervision of work, As far as possible from the licensing, supervision and many other areas to strengthen management, Improve the early warning mechanism, As far as possible to achieve early detection,early prevention early treatment of cases of drug quality, Strengthen sector collaboration, Establish a "Greater supervision" concept, To achieve seamless regulatory, Form a regulatory force, Drugs continue to expand the community co-management power, Expansion of drug monitoring team, Compensate for inadequate supervision of power, Continue to strengthen self-discipline of enterprises, to prevent occurrence of cases of quality of Pharmaceutical Products from the source, From the laws and regulations, departmental collaboration, the implementation of quality management standards and other medical institutions to strengthen all-round quality control of drugs, Vigorously carry out publicity activities to enhance people's sense of self-protection, To achieve mass prevention, Through the comprehensive implementation of the above measures to improve drug quality control measures of the appropriateness and relevance. |