On The Legal Regulation Of The Risk Of Adverse Drug Reactions

From the han dynasty,when the taoists extended their time and skill,to the Ming dynasty,when the nobles sought the immortal and asked for the medicine,to the current national fitness campaign,the people's pursuit of health has never stopped.The benefits of drugs to human health are self-evident,and it is precisely because of the public's desire for health that the rapid development of the drug industry is promoted.China's drug-related enterprises are developing vigorously in the market economy of reform and opening up,which not only provide high quality and inexpensive drugs for clinical use,but also make great contributions to the protection of national health.However,the safety of the drug is not absolute after it has been approved by the drug regulatory department.There are still many known side effects or safety risks that have not been grasped at the technical level at that time.Drug safety is the direction of continuous efforts by drug regulatory departments of various countries,and measures such as risk monitoring,reporting,recall and relief of adverse drug reactions are the main means for drug regulatory departments to manage drug safety after marketing.In recent years,the incidence of adverse drug reactions(adrs)is frequent,and the human needs for health are more urgent.Based on this background,this paper takes the legal regulation of adrs risk in China as the research object,and makes a comprehensive and in-depth discussion.This paper is divided into four parts:The first part is the overview of the legal regulation on the risk of adverse drug reactions.Adverse drug reactions(adrs)refer to the harmful reactions that occur in the normal usage and dosage of the qualified drugs and have nothing to do with the purpose of use.There are three major components of adverse drug reactions: the drug must be approved and qualified,the drug must be used reasonably,and it must be unrelated to the purpose of drug use or an unforeseeable reaction.Studying the legal regulation of the risk of adverse reactions is conducive to urging the drug market licenees and drug-related enterprises to fulfill their legal obligations,realizing the regulatory function of the government,and safeguarding the right of the victims to remedy.The second part is the legal regulation and evaluation of the risk of adverse drug reactions.The United States,the European Union and Japan have formed relatively perfect systems for avoiding the risk of adverse drug reactions,which are manifested in relatively perfect monitoring and reporting system,emphasis on information disclosure,efficient emergency treatment mechanism and clear relief mechanism.The third part is the current situation and problems of the legal regulation of adverse drug reaction risk in China.After years of adverse drug reactions risk research in China,basic on the adverse drug reaction monitoring,reporting,emergency treatment to establish the corresponding legal system,but still there is medicine in licensor monitoring and reporting system is not sound,adverse drug reactions that program,and lack of emergency response is not efficient,adverse drug reaction relief mechanism.Part iv,Suggestions on improving the legal regulation of adverse drug reaction risk in China.To improve the legal regulation of adverse drug reaction risk in China,we should standardize the legal obligations of drug license holders,optimize the cooperation mechanism of drug-related institutions,and establish the monitoring entrustment mechanism of drug license holders.We will improve the risk identification mechanism for adverse drug reactions.We will strengthen emergency response to adverse drug reactions,expand the disclosure of information,improve the drug circulation traceability mechanism,and improve recall measures.Finally,establish the fund relief mode.