Study On The Legal Systems Of Biotech Drug Safety Regulations In China

At present,the biotechnology drug industry in the world is developing rapidly,and China should promote the development of the industry while ensuring the standardization and safety of the development of the industry.At the beginning of this paper,the concepts and logical relationships of biotechnological drugs and their safety risks are clarified.This paper analyses the characteristics of security risk,such as concealment,irreversibility of damage results and pan-regional,and demonstrates that it has greater systemic security risks than traditional drugs.Based on the successful experience of biotechnology drug regulation in developed countries,such as the United States and the European Union,and the analysis of systematic drug quality risk management system norms,the feasibility and necessity of introducing risk management theory to prevent and control the risks of biotechnology drugs were demonstrated.This paper argues that the single concept of drug quality based on drug effectiveness should be changed,and the quality concept of drug quality = safety + effectiveness + stability should be formed.It is proposed that "safety" is the first factor to evaluate the quality of biotechnological drugs.The concepts of "quality comes from design" and "vigilance is more important than monitoring" are put forward.Although there are many differences in contents and concerns between the two concepts,there are common goals and value pursuits in the research and development,production,use and management of biotechnological drugs,namely;quality control,safety and effectiveness.The safety risks of biotechnological drugs,which affect human production,life,law,social relations and ethics,need to be responded to by national laws.In the design of the legal system for regulating the safety supervision of biotechnological drugs,the value orientation of law should take into account both legal justice and order.In the aspect of justice value freedom,the law should clearly define the content and marginal scope of freedom,and provide a variety of legitimacy models for the subjects of biotechnology drug research and development,production and use.On the equal side of justice value,the law should guarantee the realization of the principle of reasonable difference on the basis of choosing equal legal status,equal opportunity and equal treatment.As for the value of order,it focuses more on the two aspects of security and predictability.In view of the potential and harmful characteristics of biotechnological drug safety risks,predictability requires that the establishment of the legal system of risk supervision of biotechnological drugs must be advanced and presupposed,the legal system of drug safety risk supervision should be established to prevent and control risks in the future,and the prevention and control should be based on the response after the event.Establishing the legal system of biotechnology drug safety supervision should be guided by social order and put the value of justice into all aspects of safety supervision by realizing the value of order.This study combs the process of drug regulatory policy changes and come up with the interaction of "problem stream","policy stream" and "political stream" that can be clearly observed in the changes of drug regulatory policies.Based on the theory of risk management,through literature research and comparative study,this paper compares the regulatory systems of foreign countries,and determines the research framework and focus of the legal system of biosafety regulation in China.This paper makes an in-depth analysis of the four basic systems of drug supervision in China,including quality management of drug production,ethical review committee,drug license holders and drug vigilance,and compares the legal systems and regulatory bodies of drug supervision in developed countries and regions such as the United States,the European Union,Japan and so on.It objectively reflects the supervision of our country.There are some problems in the establishment of legal system and regulatory body as a whole: firstly,the establishment of legal system for drug safety supervision is not scientific and systematic enough;the lack of important systems,the inconsistency of system design concepts and standards;and the lack of specific operability and refinement standards.Secondly,the regulatory agencies lack independence,the level of science and technology needs to be improved,and the regulatory capacity of the regulatory team is generally not strong.Thirdly,drug regulation in China mainly relies on the top-down constraints of the government,and the industry and public participation is not high.According to the differences of main contents,main bodies and execution methods of the standards,this paper suggests that China should closely focus on the two systems of "drug quality and safety management system" and "drug safety risk management system",and construct a system of quality and safety management of biotechnological drugs from four levels of regulations.Improve the legal level of the basic system of GLP,GCP,GMP and GSP quality management.These four standards are the basic norms of drug quality and safety management,which should be followed by drug-related units,enterprises and individuals.It is necessary to supplement and improve the system rules,refine technical standards and operational guidelines,and enhance the mandatory and operational implementation of the system.As soon as possible,we should establish the legal system of the Medical Ethics Review Committee,the Regulations on the Protection of Subjects and the detailed rules for its implementation;establish national ethics expert committees,cross-administrative medical ethics review committees,hospital ethics review committees,institutional ethics review committees and special ethics review committees at different levels and classifications.To ensure the validity,authority and social recognition of the results of ethical review.In the risk management system of drug safety,firstly,we should clarify the rights and obligations of drug licensing holders in the life cycle of drugs as soon as possible in the system norms;clarify the quota conditions of drug licensing holders;scientifically establish the principle of liability attribution in the licensing system,and propose to implement the principle of double liability;and study and establish the system of drug damage relief to better protect the interests of patients.The second is to rapidly promote the construction of drug warning system.From the formulation of the legal system of drug vigilance,the establishment of a comprehensive operation system,the construction of a vigilance technology platform three-pronged approach.Assessment of drug safety based on adverse reaction monitoring and comprehensive analysis.