Analysis on the expression of drug standards and related issues in the newly revised Drug Administration Law / 中国药房

OBJECTIVE To sort out and analyze the expression and provisions of drug standards in the text of the newly revised Drug Administration Law ，and to explore the connotation and legal positioning of drug registration standards so as to provide reference for the rational application and interpretation of relevant provisions of drug standards in Drug Administration Law . METHODS Through the review of the evolution of drug standard management in China ，the legal provisions of drug standard in the Drug Administration Law were analyzed. Comparative study and literature research methods were used to analyze the legal expression and connotation of drug standards. RESULTS & CONCLUSIONS There were different expressions about “national drug standards ”“drug standards ”and“quality standards ”in the current provisions of the newly revised Drug Administration Law ； the legal position of the provincial-level standard for the preparation of Chinese herbal pieces was not clear ，and there may be insufficient legal regulation in the enforcement of drug administration. It is necessary to make an administrative interpretation for the content of relevant drug standards and provisions ，and further clarify the legal attributes of drug standards in the processing of provincial Chinese herbal pieces in order to promote the standardized management of Chinese herbal pieces.

Study on Main Changes of Counterfeit and Inferior Drugs ’Relevant Provisions in the Newly Revised Drug Administration Law and Their Impact on Law Enforcement / 中国药房

OBJECTIVE：To provide reference for further clarifying the definition of counterfeit and inferior drugs and law enforcement for revelent departments ，and guaranteeing the safety of drug use and legitimate right for the public. METHODS ： Through comparative research ，literature research and interpretation of the new law ，comprehensive analysis and research was conducted for the relevant provisions of counterfeit and inferior drugs in the newly revised Drug Administration Law in respect of the definition ，penalty rules and identification basis of counterfeit and inferior drugs. The challenges and impacts of these changes on drug law enforcement were put forward from the perspective of drug law enforcement practice. RESULTS & CONCLUSIONS ： In terms of definition ，the newly revised Drug Administration Law redefined the counterfeit and inferior drugs ，which was reduced from 15 cases before the amendment to 11 kinds，but the content was more abundant. It cancelled the concept of punishing counterfeit and inferior drugs ；increased the prohibition of the use of counterfeit and inferior drugs ；punished violation behavior of drug administration order not according to counterfeit and inferior drugs ；removed two items that being punished as counterfeit drugs；adjusted the definition of contaminated drugs from counterfeit drugs to inferior drugs ；clarified the definition of excipients. In terms of penalty provisions ，the provisions of legal liability for counterfeit and inferior drugs in the newly revised Drug Administration Law comprehensively used a variety of punishment measures ，greatly increased the amount of fine ；differentiated the situation of production ，wholesale and retail of inferior drugs ，and set different punishment ranges ；appropriately reduced the punishment range of producing and selling TCM decoction pieces that did not meet the drug standards ；increased the punishment for the violation of drug management order ，and the scope of punishment was similar to that of counterfeit and inferior @qq.com drugs. The “double penalty system ”was implemented for serious illegal acts and punished to individuals. The punishment for drug users who used counterfeit and inferior drugs was clarified. The situation of heavier punishment for producing and selling counterfeit and inferior drugs was increased ，and the first responsibility system and punitive compensation were added to protect the legitimate rights and interests of consumers. In terms of identification basis ，the newly revised Drug Administration Law had deleted the provisions that specific situation of quality inspection conclusion may not be specified ，and only provided the principle provisions. The challenges and impacts of the newly revised Drug Administration Law on law enforcement included how to understand the “ingredients”in the definition of counterfeit drugs；how to distinguish between deteriorated drugs and contaminated drugs ；how to investigate and deal with unauthorized acts ； whether drug inspection reports were required in all cases of counterfeit and inferior drugs ；how to understand the situation that did not affect the safety and effectiveness ，and connecting administrative law enforcement with criminal justice for counterfeit and inferior drugs ，etc. It is suggested to further strengthen the law popularization ，and introduce the interpretation of the newly revised Drug Administration Law as soon as possible ，clarify the legislative intent ，and guide the grassroots law enforcement ；issue Amendment Ⅺ to the Criminal Law of the People ’s Republic of China as soon as possible ，increase the charges of illegal acts against the order of drug administration ，do a good job in connecting administrative law enforcement with criminal justice and crack down on the illegal and criminal acts in the field of drugs ，and further promote the administration according to law.

Research Progress on the Defects and Improvement of Drug Administration Law / 中国药房

OBJECTIVE:To provide reference for revising Drug Administration Law.METHODS:By reviewing the pertinent literature,the defects of the Drug Administration Law and the suggestions on its improvement were analyzed comprehensively.RESULTS & CONCLUSIONS:The Drug Administration Law was imperfect in that the concept of"drug"was not scientific,the division for counterfeit and substandard drugs was not reasonable,graded penalty based on the factors such as the primary-secondary responsibility,subjective factor,the severity of consequence etc was not imposed,and the legislation for some of the links was absent etc.It can take the Food,Drug and Cosmetics Law in US as reference to revise the Drug Administration Law by revising the concept of"drug",classifying the unqualified drugs,rectifying the legislative absence of the original links,making a balance between legal liability and the legal obligation so as to achieve gradual perfection.