Research On Drug Circulation Regulatory Problems Existing In China

Drugs are special commodities which related to people’s life and health and are also fundamental to the people’s livelihood.Drug safety is the base line we have to stick to protect the interests of the masses.Drug circulation is a entire process which concerns pharmaceutical enterprises,the wholesale enterprises,pharmacies or hospitals and other terminal sales to the consumer,this process affects drug quality safety and is a key element of drug safety.Drug circulation regulation is a hot worldwide social issues that governments,academia,business of the world are paid close attention to.China has formulated or revised The pharmaceutical administration law of the People’s Republic of China and The implementation regulations of the pharmaceutical administration law of the People’s Republic of China and related laws and regulations,especially on May 1,2007 The measures of supervision and administration of the drug circulation has been issued and implemented,and in May 2014,Deepen reform of the medical and health system,puts forward "three medical institutes linkage",which fully reflects the drug circulation’s key position of the medicine and health care system in our country.In our country’s,drug distribution is a complex systems which involves production enterprise,agent dealers,all levels medical representative,hospital pharmacy,the doctor(department),and other links,this process concerns many interest subjects,long circulation channels,more complex trading channels.Although China has issued a series of laws and regulations,there are still many loopholes in the regulatory link and regulatory vacuum belt,leading to frequent medicine circulation safety issues in recent years.Exposure of Shandong illegal vaccine case in March 2016,without strict of the vaccine cold chain storage transportation involved 570 million sold in the country.The case involved nearly 80 cities,24 provinces throughout the country,the amount is huge,very bad influence,exposed the importance and urgency of drug circulation regulation.In our country’s,drug distribution is a complex systems which involves production enterprise,agent dealers,all levels medical representative,hospital pharmacy,the doctor(department),and other links,this process concerns many interest subjects,long circulation channels,more complex trading channels.Although China has issued a series of laws and regulations,there are still many loopholes in the regulatory link and regulatory vacuum belt,leading to frequent medicine circulation safety issues in recent years.In this paper,take Shandong illegal vaccine as the breakthrough point,combine the theory of market failure,government regulation theory and social governance theory,use the literature research and analysis as references,draw conclusion through normative analysis and comparative analysis of foreign drug regulatory status.Firstly,this article introduce the background and significance,related concepts,research ideas and research methods,etc.,point out the research significance and practical significance under the new medical reform situation.Secondly,basing on the drug circulation of illegal vaccine case typical cases,the paper analyze medicine circulation regulatory system,laws and regulations and policy system,supervision and regulatory problems existing in the new situation,and draw lessons from the United States,Japan,Germany and other developed countries valuable experience in drug supervision.At the same time,combining with the condition of socialist market economy in our country and the current situation in the field of drug circulation,we put forward the following countermeasures:Strengthen the medicine circulation regulation mechanism;Improve the drug circulation laws and regulations;Construct of medicine circulation regulation professional team;Promote the drug circulation regulation subject interactive cooperation.Build a new comprehensive model of Internet + drugs,establish a national unified drug network sales monitoring platform.These five counter measures present three-dimensional supervision suggestions from top to bottom(the government regulation system to the basic department),from inside to outside(government regulation to social interactive cooperation,from online to offline(traditional regulation to network regulation).