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中华人民共和国药品管理法(双语)(1)

2014-02-25    来源:网络    【      美国外教 在线口语培训

中华人民共和国药品管理法
LAW OF THE PEOPLE'S REPUBLIC OF CHINA ON THE ADMINISTRATION OF DRUGS

第一条为加强药品监督管理,保证药品质量,增进药品疗效,保障人民用药安全,维护人民身体健康,特制定本法。
[Article 1] This law has been drawn up in order to strengthen drug control and administration, ensure the quality of drugs, enhance the efficacy of drugs, guarantee safe drug use and safeguard the physical health of the people.

第二条国务院卫生行政部门主管全国药品监督管理工作。
[Article 2] The State Council department responsible for health administration is the body in charge of national drug control and administration.

第三条国家发展现代药和传统药,充分发挥其在预防、医疗和保健中的作用。
[Article 3] The State develops both modern medicines and traditional medicines, and fully utilises them in the prevention and treatment of disease, as well as in health care.

国家保护野生药材资源 鼓励培育中药材。
The State safeguards resources of uncultivated medicinal materials and encourages the cultivation of raw materials used for traditional Chinese medicines.

第二章药品生产企业的管理
CHAPTER II ADMINISTRATION OF DRUG-PRODUCING ENTERPRISES

第四条开办药品生产企业必须由所在省、自治区、直辖市药品生产经营主管部门审查同意,经所在省、自治区、直辖市卫生行政部门审核批准,并发给《药品生产企业许可证》。
[Article 4] The establishment of a drug-producing enterprise must be examined and agreed to by the department in charge of drug production and handling in the province, autonomous region or municipality under the direct control of the Central Government in which the enterprise is located. It shall be subject to examination and approval by the department responsible for health administration in the province, autonomous region or municipality under the direct control of the Central Government, which shall issue the "Drug-production Enterprise Licence".



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