Research On Regulation Of Drug Safety In China

Since our country is founded, the Government is the only regulator in drug regulation fields. It undertakes almost all of the regulatory works, including drug legislation, enforcement of law, justice and other areas of drugs. With the development of market economy and the emergence of civil society, the traditional pattern of regulation to solve the drug safety issuses have been gradually exposed drawbacks. Especially in recent years, it has occurred several significant medical cases which make us concern the issus. Leaning effective experience from developed countries, and using new governance theory, the paper advocated to establish multi-regulatory approach to solve the dilemma of drug regulation. This approach is based on the Government as the main body, while allowing and encouraging the market and social forces to participate.Based on the principles and requirements of governance theory, combining the theoretical and practical method, this research gets to the conclusion of multiple regulation. First, the paper discusses of the status quo and the problems of drug safety. Then find the causes. In summary, there are two two aspects:first is the problems of regulator; second is the issue of external support systems. In the end, according to our country's reality, and learning from experience of developed countries, the article presents a diverse regulatory mode to solute the current problems of China's drug safety.This new regulatory mode advocated the Government should play a leading role and clarify the functions of the various regulatory authorities, and continuously improve the Government's regulatory system, their ways and responsibility system; Second, we must create external support system (market,trade associations, consumers and the media)for Government, and make them play good supporting role. This needs to improve laws and rules constantly, in order to provide adequate legitimate channels to participate the drug regulation.Meanwhile,the government should supervision and governce external support system. A sound regulatory mode not only should have positive guidance and incite, but also should have some punishment mechanism, in order to make the mode feasible.All in all, drug regulatory authorities, the majority of pharmaceutical companies, consumers and social forces have a common goal for drug safety issues. Drug regulatory authorities must strengthen regulation, punish the acts of disturbing the market order,so as to provide a fair and equitable environment for competition; pharmaceutical companies must be enhance self-discipline, enhance core competitiveness, to provide consumers with more and better products; industry associations must connecte companies and Government, both serving them,and urging them to fulfill their respective responsibilities; consumers must timely reflect unforeseen cases and provide useful advice and fully express their legitimate interests, so that governments, businesses can accurately get consumer's demand. The Government, enterprises, guilds, and consumers should work together to solve the drug safety issues, Only by this way, we can establish order drug market environment, protect public health and promote Chinese medicine industry to develop rapidly.