A Research On Drug Safety Regulation In Kunming

In the course of human progress, one of the most important and basic factors to maintain self-reproduction and development of human society has always been to ensure drug quality and health care. At present, the risk of drug safety in China occurs frequently just as China is in the social transition. In order to improve the regulatory capacity and service quality, China puts forward the new conception:to establish and carry out the scientific supervision. Kunming, the political, economic and cultural center of Yunnan Province, draws more than 70% of the province's pharmaceutical manufacturers and 80% of the pharmaceutical enterprises. It is not only the hinge of drug production and distribution in Yunnan, but also the largest distribution center and source for counterfeit drugs in the whole province. And this research on drug safety supervision in Kunming, by analyzing the situation of drug safety regulation in Kunming, aims to probe into the issues of drug safety regulation and its causes, and brings forth measures to solve the problems of drug safety supervision. It will be meaningful to perfect the drug safety regulation, guarantee drug safety for the masses, promote the sound development of pharmaceutical industry, and accelerate the social construction focusing on the improvement of people's livehood.This paper takes the regulation of drug safety in Kunming as the research object. Starting from the necessity of drug administration, this paper proposes that it is imperative to have a research on drug safety supervision in Kunming in the context of the status quo of the dug safety regulation in China. And then, on the basis of my own practice and the collection and analysis of relevant information, it is considered in this paper that although significant achievements and great progress have been made in drug safety of Kunming, problems like the less orderly drug markets and inferior drugs restrict the development of the Kunming Pharmaceutical security. Thereafter the main causes of the problems of drug safety regulation are presented through policy analysis and the analyzing of the corresponding public policy. And these reasons are the powerless supervision of regulatory authorities, the low level of the pharmaceutical industry, the weak self-discipline and the lack of honesty of the supervising target, disorganized drug industry and inadequate safety awareness of the masses etc. Finally, by the comparative analysis and the combination of theory and practice, based on the theory of the drug safety, following the general rule of the development of drug safety, borrowing from the regulatory experience of other countries and regions, combining the previous studies and years of my practice, from the perspective of drug safety regulation, series of measures to solve these problems are presented.In the analysis of measures and solutions to the problems, to ensure the safe and effective use of drugs are highly emphasized. Enterprises, government, society, consumers have their own responsibilities. The self-discipline of enterprises is fundamental. Regulatory enforcement is the protective force. The joint effort of the whole society is the key. These measures are creatively proposed as follow. Drug testing institution is established to increase technical support and improve the regulatory efficiency. Kunming Pharmaceutical Industry Association is set up to well play the role of industry regulation. The limited access to legal representatives of the enterprises is carried out to strengthen legal awareness of enterprises and improve its self-discipline of enterprises. At the same time, the concept of scientific development is adopted to guide drug safety regulation, to improve the regulatory mechanism, to straighten out the regulatory function, to strengthen the organization, to innovate the regulatory approaches. In conclusion, a new pattern of drug safety regulation is to be formed. And in this pattern, government is powerful in arrangement, relevant departments regulate effectively, enterprises are honest and self-disciplined, the pharmaceutical industry develops healthily and the participation awareness of the public enhances across the broad.