Study on Some Issues about Improving the Regulation of the Drug Safety in China
|Course||Constitutional and Administrative Law|
|Keywords||Drug Safety Regulation Drug Injury Event Information Disclosure ADR Remedies|
Drugs are a special commodity, Drug Safety issues related to people’s livelihood, involving millions of households. Therefore, the Drug Safety monitoring are not only building a socialist harmonious society in China the practical requirements, but also safeguard the health and safety of people’s lives and an important guarantee. However, since 2006 have occurred in more than a major injury incidents and Drug Safety Regulation System of the corruption cases, making the Drug Safety become the focus of the community, from which exposed the drug research, production, distribution and use of part of the outstanding problems, reflect the current pharmaceutical market order and chaos, but also reflects the work of drug regulation loopholes. Regulation functions of the position is not accurate, institutional setting unreasonable design of the system is imperfect, unscientific factors such as regulation of Drug Safety problems are caused by deep-seated institutional reasons. In this paper, the typical case to follow the questions, analyze problems, to solve the problem the main line of the general demonstration act to Improving the monitoring of Drug Safety discussion from the following aspects: the first part of the article on China in recent years occurred in the field of large Drug Safety cases for the case of brief, discover problems, highlighting the problem of universals; the second part of the article of Drug Safety were related discrimination, a brief overview of the theory of government regulation; from the legislative and institutional level review of the development of China’s Drug Safety supervision system and the current achievements. The third and fourth part is the focus of the article, the third part of the Drug Regulation of China trying to negative symptoms appear to analyze and find the cause of the problem reflected in the cases summarized in four aspects of Drug Safety monitoring of adverse symptoms:Drug Safety monitoring system is a high incidence of corruption; Second, Drug Safety information is not public or to disclose in a timely manner; third injury event be difficult to remedy; four-movement style is ineffective Drug Safety monitoring. The fourth part is the correct approach by eleven for the third part of the feasibility of measures proposed by the four outstanding issues, including the power to control Drug Safety supervision, improve the Drug Safety information disclosure mechanism to protect the citizens right to information, the establishment of system of adverse drug reactions and Drug Remedies long-term safety supervision mechanism to effectively deal with the issue of Drug Safety, and promote the healthy development of China’s Drug Safety supervision, to ensure the Drug Safety of people.