Research On Drug Recall Legal System

As a double-edged sward, on the one hand,drug is a special risk product which takes the function of prevents and cures diseases and protects public health，on the other hand, its side-effects and serious adverse reactions can harm the human. As regulators, government should take some measures like drug recalls when these some security risks.The promulgation and implementation of Administrative Measures for Drug Recalls is significant to protecting the rights of consumers which make sure of the security of drugs for people. As the result,the companies have become more honest that is good for themselves.there are six years from the beginning of the promulgation and implementation of Administrative Measures for Drug Recalls. On the one side, China has achieve some success; on the other side,there are also some problems,such as the recall information system is not perfect;government regulation and enterprises’ responsibility is not enough as much as possible.Improving the drug recall system is the best choice for China drug security regulation in the long term.The paper starts from theoretical analysis drug recall system，through the comparison with United States and other developed countries， leads to problems existed in legislating and implementing process of our current drug recall system，and finally put forward ideas and proposals for the perfection of current drug recall system in our country.The paper is divided into four parts:The first part，summarizes drug recall system， clears concept and legal characters of drug recall system，defines the objects of drug recall system in our country， analyzes differences between drug recall system and other products recall system，and finally describes meaning of drug recall system.The second part，through the elaboration of drug recall system in United States， Australia and Canada，analyzes the enlightenment to china. Mainly concludes:improving the legislative system,clarify the function of government in advising and regulation,make the recall information system as standard as possible.The third part， summarizes legislative status of drug recall system in our country， compared with China’s actual situation，raises questions existed in legislating and implementing process of our current drug recall system，mainly concludes our Administrative Measures for Drug Recalls is low in terms of legal effect，recall information disclosure system is lack of a specific and uniform standards，the absence of government responsibility，blocked drug recall channels，domestic pharmaceutical production enterprises unable to undertake drug recall obligations，and legal liability is light.The fourth part， in view of the present disadvantages of our current drug recall system，compared with foreign experience，makes reasonable suggestions to add drug recall chapters in Administrative Measures for Drug Recalls，clear information disclosure system， perfect government’s responsibility in drug recall legal relations，set up drug informatization tracking system，set up drug recall liability insurance system， introduce punitive compensation system and so on.The paper attempts to interpret our drug recall system， analyzes problems existed in its legislating and implementing process and makes suggestions， and be of any assistance for perfection of drug regulatory system in our country.