Analyze The Related Legal Problems Of The Drugs Safety Supervising

Along with the society pay more and more attention to the drugs safety,it is urgent to enlarge the drugs safety supervising and enhance the drugs market standardization degree and the safety of using medicine. In order to safeguard the safety of using medicine, we must speed up the drugs safety laws and regulations system. At the foundation in searching the loophole of supervising, unify fundamental realities of our country,advance the revision work and making of the drugs safe supervising laws and regulations, and enhances the legal standard of law, in order to build a consuming environment which is secure, health, felt relieved for the people. This article elaborates supervising condition in the essential link of drugs developing, producing, using and so on, and carries on the analysis from the whole to the related law system.First chapter summarizes the content in the aspect of the drugs production permission and the healthy product production permission standard. It mainly is about the drugs production permission, the medical establishment preparation permission. Simultaneously, it introduces the new "Health foods Registration Policing method". Second chapter firstly elaborates the drafts, revision and implementation of GAP, then introduces the related regulation of GMP and the Medical Establishment Preparation Quality Management Standard, the related regulation of GLP and GCP, in addition, regarding to the GMP authentication and the related regulation of "the Medicine Clinical test Organization Qualifications Recognized Means (Implementation)", it also has made the elaboration.In the third chapter, through the detailed introduction to drugs classification and medicine table of contents, from analysis of the international and domestic correlated regulation, China should consummate the drugs classification management, strict drugs appraisal examination and approval system, establishes and perfect drugs market to entering and withdrawal system, enhance the people' s cognition to medicine table of contents.Fourth chapter first introduces the meaning and the legislation of drugs re-evaluation, the drugs no-good response monitoring. Regarding to the existing problems, China should value legislative work, for example, regulates: if factories don' t report the information of the drugs no-good response, they should undertake the legal liability, as well as the drugs recalling system.The fifth chapter mainly elaborates the special drugs supervising and the monitor to the national medicine abusing. Concerning the legal laws and regulations of this aspect, this article introduces: The import and export permission related legislation, "Narcotic And Spiritual Drugs Act of administration", theradiopharma-ceuticals related legislation and "Medical service with Toxic Drugs Policing method", as well as "Medicine Abuses Monitor Network Information management system" and "Medicine Abuses Monitor Policing method" (discussion manuscript). Sixth chapter is this article overall analysis part. Its key analysis is about laws and regulations and corresponding legal consciousness and the legal relief system, which includes the recalling system, the drugs not-good response relief system; At the specialized technical aspect, it specifically introduces the Evidence-based Medicine, the IT technology utilization, the big sample multi- centers stochastic clinical test, the medicine abusing monitor network information management system; "Three medical linkages reform" also is a key elaborating point in this article,it can be said that the medicine guarantees reform is the foundation of the reform. In addition, at present the regulation of this aspect in the medicine association, the facilitating agency (for example GMP or GSP advisory service facilitating agency) has big vacancy.The last chapter summarizes the research conclusion of the paper , aims at the drugs security importance as well as well as the existing problems, and unite research conclusion of this article, proposed several suggestions to complete the drugs safety supervisory work, they are: First, supplement and perfection of laws and regulations; Second, good technical construction and the drugs safety information should be scientifical, and public, and it should be easy to get and understand the information;Third,coordinate benefit in every main body, and take the medicine guarantees reform as a foundation to seek the Max. efficiency of "three medical linkages reform"; Fourth, encourage, instruct and regulate public welfare organization such as medicine association and GMP, GSP advisory service facilitating agency and so on.