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Suggestions On The Improvement Of My Country's Special Management Drug Administrative Regulations

Posted on:2019-04-04Degree:MasterType:Thesis
Country:ChinaCandidate:Y Y FanFull Text:PDF
GTID:2434330596472058Subject:Pharmacy
Abstract/Summary:PDF Full Text Request
Objective: to analyze drug administration regulations since the founding of our country’s special system,special drug administrative regulations of our country to conduct a comprehensive and in-depth analysis and research,exploration in the practice of special drug laws and regulations system highlight deficiencies and defects,and put forward the perfect proposal,for our revision of special drug administrative rules and regulations for reference.Methods: based on the "drug risk theory" as the main theoretical basis,using literature research,searching through a large number of relevant literature,induction,analysis of the contents of the literature,and related laws and regulations for specific drugs and drug regulatory department’s annual report,yearbooks,etc,to form a special drug laws and regulations in China the scientific understanding and regulatory mode,and provides a basis for further research.The drug regulatory department of law enforcement personnel,adverse drug reaction monitoring and reporting on the basis of interview in terview outline has been worked out,through questions,summarize the current situation and existing problems of special drug supervision,to discuss the perfection of special drug regulatory Suggestions.Results:the special problems of drug administrative regulations system mainly include the following:first,narcotic drugs and psychotropic drugs administrative regulations,the overall status is low,the lack of detailed rules for the implementation,the supporting documents not comprehensive;The second kind of psychotropic drug administration is poor,and it is easy to arouse the abuse of the second kind of psychotropic substance in the real world.The second is that the system of medical toxicology is lagging behind,which is not operable and can not meet the needs of real supervision.The regulation does not define the range of toxic drugs.Third,the definition and scope of radioactive drugs are not scientific.Lack of laws and regulations,supporting documents and supporting measures;The regulation of positron emission drugs is weak,the relevant laws and regulations are not operable and lack of guiding significance.The legislative branch should amend the lagging regulations,improve the level of the regulations,supplement the supporting documents,improve the supporting measures,and scientifically define the definition and range of special drugs.Regulators should strengthen regulation of the second category of psychotropic drugs and positron radioactive drugs,and improve the status of weak regulation of such drugs Conclusion: special medicines for our country administrative legislation perfect suggestion is: according to the situation of our country special drug laws and regulations,timely revision added to perfect the relevant supporting documents and supporting measures,scientific definition of the definition of toxic drugs for medical use and radioactive pharmaceuticals and variety range,to strengthen the second category of psychotropic drugs and positron radioactive drugs regulation,reduce drug safety hidden trouble.
Keywords/Search Tags:Specialty drugs, Administrative supervision, Regulations, Suggestion for perfection
PDF Full Text Request
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