In order to exert the effect of medicine guild on Chinese drug administration,medicine guild has to be independent,and the relative law should be set up,that can ensure function of medicine guild,perfect itself and aware of the competition,etc.
在协助国家药品监督管理工作中发挥积极作用。
Based on relevant theories in the Administrative Law, th e authors demonstrated and analyzed current drug administration practice, and su ggested to regulate discretional acts in drug administration by following up sui table principles and taking some measures.
文章在对行政法中相关理论进行阐述的基础上 ,结合药品监督管理实践进行论证分析 ,认为把握适当原则、采取一定措施 ,对药品监督管理中的裁量行为进行规范 ,有益于裁量行政行为的合理实施。
To carry out and perfect the responsibility system in dr ug law administration is an important measure for drug administration units, esp ecially those under provincial level to strengthen responsibility, make legal ma nagement.
药品监督管理行政执法责任制的全面推行和完善 ,是药品监管机关、特别是地方省以下各级机关 ,强化药品监管行政责任 ,严格依法行政的重要保障措施。
According to USA FDA,and EU EC,EMEA,and FVO related regulations,this paper introduced the basic registration requirements of Chinese Traditional Medicine to apply marketing authorization in USA and EU.
参阅美国食品药品监督管理局(FDA,Food and Drug Administration);欧盟委员会(EC,European Commis-sion);欧盟药品审评局(EMEA,The European Agency for the Evaluation of Medicinal Products)及欧盟食品兽医办公室(FVO,Food and Veterinary Office)有关法律法规文件,就中药在欧美国家申请上市注册的基本要求做简要介绍。
Briefly introduce the problems that FDA of America is facing related to drug risk man-agement as well as solutions to the system in order to explore effective approaches of drug risk management.
通过介绍美国食品药品监督管理局面临的药品风险管理问题及改进建议,以便探索对我国有借鉴意义的药品风险管理模式。
This text followed the working progress after Drug Safety Oversight Board (DSOB) of FDA established.
通过跟踪美国食品药品监督管理局新成立的“药品安全监督委员会”的工作进展,了解其近期开展的工作内容和程序,以期对我国的药品风险管理体系建设和完善有所启示。
State Drug Administration (SDA)
国家药品监督管理局
State Drug Administration [China]
国家药品监督管理局〔中国〕
the State Drug Administration ("SDA") was responsible for administrative protection of pharmaceuticals;
国家药品监督管理局(“SDA”)负责药品的行政保护；
The Guangzhou Quality Supervision and Inspection Center for Medical Instruments Under the State Drug Administration
国家药品监督管理局广州医疗器械质量监督检验中心
Beijing Center for Medical Device Quality Supervision and Testing of State Drug Administration
国家药品监督管理局北京医疗器械质量监督检验中心
Order of the State Food and Drug Administration
国家食品药品监督管理局令
State Food and Drug Administration
国家食品和药品监督管理局
Decree No. 6 of the State Food and Drug Administration of the People's Republic of China, Promulgating the Measures for the Administration of Business Licenses of Drugs
国家食品药品监督管理局令第6号,发布《药品经营许可证管理办法》
and shall simultaneously submit it to both the State Food and Drug Administration and the National Institute for the Control of Pharmaceutical and Biological Products.
同时报送国家食品药品监督管理局和中国药品生物制品检定所。
Beijing Drug Administration
北京市药品监督管理局
In terms of the biological products within the range of examination, approval and issuance specified by the State Food and Drug Administration,
国家食品药品监督管理局规定批签发的生物制品，
For a biological product within the range of examination, approval and issuance specified by the State Food and Drug Administration
国家食品药品监督管理局规定批签发的生物制品
The packages and labels of the drugs that have arrived at the port are inconsistent with the requirements of the State Food and Drug Administration;
到岸品种的包装、标签与国家食品药品监督管理局的规定不符的；
The biological products as prescribed by the State Food and Drug Administration; The drugs sold within China for the first time; Other drugs as prescribed by the State Council
国家食品药品监督管理局规定的生物制品；首次在中国境内销售的药品；国务院规定的其他药品。
The power to interpret the present Measures shall remain with the State Food and Drug Administration and the General Administrations of Customs.
本办法由国家食品药品监督管理局和海关总署负责解释。
shall be separately formulated by the State Food and Drug Administration and the General Administration of Customs.
由国家食品药品监督管理局与海关总署另行制定。
The relevant information shall be reported to the State Food and Drug Administration in time,
有关情况应当及时报告国家食品药品监督管理局，
To supervise and address the problems found in import record keeping and port inspection; Other matters as provided for by the Sate Food and Drug Administration.
对进口备案和口岸检验中发现的问题进行监督处理；国家食品药品监督管理局规定的其他事项。