常用药品监管词汇中英文.doc

1.《中华人民共和国药品管理法》 Drug Control Law of the Peoples Republic of China 2.药品生产企业管理 control over drug manufacturers 3.药品经营企业管理 control over drug distributors 4.医疗机构的药剂管理 control over medicines in medical institutions 5.药品管理 control over drugs 6.药品包装的管理 control over drug packaging 7.药品价格和广告的管理 control over drug price and advertisement 8.药品监督 inspection of drugs 9.法律责任 legal liabilities 10.药品标识 labels or marks of the drugs 11.假药 counterfeit drugs 12.劣药 inferior drugs 13.药品检验机构 drug quality control laboratory 14.药品的生产企业 drug manufacturers 15.经营企业 drug distributors 16.医疗机构 medical institutions 17.药品监督管理部门 drug regulatory agency 18.药品批准证明文件 drug approval documents 19.行政处分 administrative sanctions 20.刑事责任 criminal liabilities 21.药品生产质量管理规范 Good Manufacturing Practice for Pharmaceutical Products (GMP) 22.药品经营质量管理规范 Good Supply Practice for Pharmaceutical Products (GSP) 23.药品生产许可证 Drug Manufacturing Certificate 24.药品经营许可证 Drug Supply Certificate 25.医疗机构制剂许可证 Pharmaceutical Preparation Certificate for Medical Institution 26.进口药品注册证书 Import Drug License 27.临床试验 clinical trial 28.新药证书 New Drug Certificate 29.药品批准文号 Drug Approval Number 30.在中华人民共和国境内从事药品的研制、生产、经营、使用和监督管理的单位或者个人，必须遵守《中华人民共和国药品管理法》 All institutions or individuals engaged in research, production, distribution, use, and administration and supervision of drugs in the Peoples Republic of China shall abide by drug control law of the peoples republic of China. 31.国务院药品监督管理部门主管全国药品监督管理工作。 The drug regulatory agency of the State Council shall be responsible for drug administration and supervision nationwide. 32.省、自治区、直辖市人民政府药品监督管理部门负责本行政区域内的药品监督管理工作。 The drug regulatory agencies of the governments of provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for drug regulation in their administrative areas. 33.药品监督管理部门设置或者确定的药品检验机构，承担依法实施药品审批和药品质量监督检查所需的药品检验工作。 The drug quality control laboratories