Drug Safety Regulatory Issues And Countermeasures In China

Since the founding, the field of drug safety under the supervision of the government was booming trend, almost all of the drug supervision work full commitment by the government departments, including the pharmaceutical legislation, law enforcement and judicial fields. In recent years, the frequent occurrence of major adverse events have caused injury us enough attention and reflection-along with the development of market economy and civil society of the complex diversity of government regulatory agencies rely on traditional ways and means of monitoring drug safety norms practice, gradually revealed its drawbacks. Western countries seeking drug safety supervision in the effective management experience, combined with the new governance theory, summarized a set of line with China’s basic national conditions of the drug regulatory system. This article argues that in order to establish a government-led, allow and encourage market forces to participate and the community, and thus the formation of a multi-regulatory approach to solve the problem of China’s current plight of drug safety supervision.Based on the theory of governance principles and requirements, and the combination of theory and practice put forward the concept of multiple regulators. Firstly, on China’s drug safety situation and the problems were specific discussion, followed by the gradual deepening of the problem to find the key. In simple terms, the impact of drug safety issues following two main factors:First, the government’s own reason; Second, external support environment. Then, learn from developed countries to effectively manage their basis of experience, based on China’s basic national conditions, the multivariate model as a solution to the current regulation of drug safety problems of the core.Multiple regulatory approach advocated not only to give full play to the leading role of the government first, namely a clear various regulatory functions of the department, continue to strengthen and improve the government’s regulatory system for drug safety, ways and means of construction and the specific responsibilities of various departments at all levels system; also actively cooperate with government efforts to build efficient supervision and management departments to external support environment, give full play to the market as the main group of the public, news media and industry associations supporting role. This requires a sound of its national laws and regulations, for the major drug manufacturers and relevant stakeholders to be involved to provide legal channels, so there are laws to go by, while their specific operational situation of reasonable supervision and management, and sound the alarm bell. A sound management mode without reward and punishment mechanism, only the pros and cons with both hands, in order to greatly improve the operability of multiple regulatory model.For drug safety issues, drug regulatory authorities, the majority of pharmaceutical companies, consumers and all sectors of society have a common goal. Drug regulatory authorities must continue to strengthen supervision, rousing, purify pharmaceutical market, providing a fair and equitable competitive environment; pharmaceutical enterprises must strictly self-discipline, and enhance core competitiveness, to provide consumers with more and better products; industry associations to play a good bridge and link for businesses and government services, and urge both parties to fulfill their respective responsibilities; consumer feedback and comments must be promptly and fully express their legitimate interests of the government, enterprises accurately informed consumer demand. Only the government, enterprises, guilds, and individual consumers to work together to solve the problem of drug safety, establish a standardized and orderly market order drugs in order to achieve the goal to protect public health and the promotion of sound and rapid development of the pharmaceutical industry.