| In 1998, in the process of institutional reform of the State Council, China's drug management system had a lot of adjustments to the establishment of the State Drug Administration. In recent years the practice shows that the work of the Drug Administration of China has achieved unprecedented progress in the settlement of the initial drug supervision and management of the pharmaceutical industry and the management of the conflict. However, we should also clearly see that in recent years, China's drug safety situation is still facing very serious. First, food-borne diseases and the high incidence of drug-induced disease, "atypical pneumonia", "bird flu" outbreak of a wake-up call to us. The second is counterfeit, Lieyao repeated, the state and the people have created a huge , It is difficult to make up for losses. Third, the law, lax enforcement of the case, as well as medicine and bribery cases occur from time to time, has seriously affected the credibility of the party and the state and dignity. As a result, the urgent need to further study the issue of China's pharmaceutical management system in order to further strengthen the supervision and management of pharmaceuticals, medical and health to promote the cause of the rapid development.Against this background, this article on China's pharmaceutical management system was discussed and put forward some suggestions for reference, hoping to contribute to our understanding of the current understanding of drug management system, with a view to further improve China's pharmaceutical management system. In this paper, through the analysis of China's drug safety supervision and management system and regulatory system of the status quo, and to learn from developed countries, drug supervision and management system and regulatory system, to make recommendations for improving our country's drug safety supervision and management system service. This article is divided into three major parts:The first part, introduced China's drug safety monitoring system, the drug safety supervision system, the need for legal regulation. In this section, explained the connotation of drug safety and concepts, detailed information on drug safety monitoring system contains, from the pharmaceutical manufacturing enterprises to pharmaceutical enterprises, from research on drugs to the supervision of medical institutions of pharmaceutical regulation, and then to the price of drugs and drug advertising regulation, as well as the form of supervision. Since then, the focus of a drug safety system, the need for legal regulation.The second part of analysis of drug safety monitoring of the status quo, to identify the causes of the problem. This section from the administrative enforcement, legislative and administrative aspects, analysis of China's drug safety monitoring system problems, have the following question: In terms of legislation, there is a shortage of technical legislation, related legislation and other issues is not perfect; On law enforcement, law, law enforcement Formal, regulatory opacity, the lack of supervision of the regulator and so some of the reasons. On this basis, looking for trouble. Drug regulators in the legislative level, the power of possession and obligations of the dislocation between the exemption, as well as patterns of behavior and legal responsibility for the imbalance is a result of the important reasons for the lack of legislation; in the system and law enforcement level, the field of pharmaceutical research and special regulation of drugs weak, adverse drug reaction monitoring systems need to implement and perfect, ineffective monitoring aspects of drug approval, medicines classified management has not yet been put in place, the role of pharmaceutical industry associations are not fully out, etc., are all leading to drug safety monitoring system is not a sound reason.The third part of China's drug safety monitoring system for the proposed law. This section first and the European Union, the United States, Japan and other foreign drug safety monitoring system for carding and Comparative Study. In the EU, drugs and medicines cosmetics Authority rating agencies should be responsible for an important drug safety monitoring agencies, is mainly responsible for the approval of drugs into the market work, is responsible for drugs submitted to the Committee to make a scientific evaluation, as well as supervision in the European Union Drugs the use of the safety and efficacy and so on. In the United States, the Federal Food and Drug Administration (FDA) under the United States Department of Health and Human Health Services, responsible for the national pharmaceutical, food, biological products, cosmetics, veterinary drugs, medical devices and diagnostic supplies, such as management. FDA will be professional technology center with the entire executive body to form one unified command scheduling, the formation of a technical supervision and administrative law enforcement agencies closely integrated system. Technical and administrative unity to ensure that the various agencies for emergency response to the rapid drug events, and guarantee the unity of the entire body and flexibility. Japan's drug safety monitoring system in more sectors, divided into more refined categories. Including: Health, Labor and Welfare, the National Institutes of Health food pharmaceuticals, medical supplies medical equipment to review Center, as well as food hygiene Pharmaceutical Affairs Council. MHLW is a medical and health, employment security, social insurance, with the implementation of the overall management advantage. Drug Administration has been formed basically prescription drugs, non-prescription drugs, Chinese herbs, the classification of types of pharmaceutical products management system, to define clear standards and classifications. Drugs re-examination, re-evaluation of management is very purposeful and systematic. This part of the final against China's drug safety problems that exist in the use advanced experience from abroad on the basis of China's national conditions, where appropriate, under the premise of a perfect China's drug safety supervision system of law several measures, including: continue to strengthen drug safety legislative work in construction; and Drug Administration to strengthen coordination between the relevant departments; standardize the administrative examination and approval drugs to enhance day-to-day supervision; the strict supervision of pharmaceutical research in the process of security; correctly handle the administrative supervision and technical supervision of the relationship; improve and perfect the Adverse Drug Reaction Monitoring communications and information systems; strengthening of law enforcement; and stepping up law enforcement, supervision, improve the punishment mechanism, increase the cost of a series of illegal ideas and measures. Some can be implemented now, while others may need to have a good environment. In any case, believe that these reform measures will have a certain direction, but also sincerely hope that China's drug safety supervision system can be further improved to ensure that drug safety and efficacy, and safeguard people's health and use the legitimate rights and interests!... |
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