药品监管汉英对照表.doc

1.《中华人民共和国药品管理法》 Drug Control Law of the People's 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 People's Republic of China shall abide by drug control law of the people's 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 established or designated by drug regulatory agencies shall undertake the responsibility for drug testing required for conducting drug review and approval and controlling drug quality pursuant to the law.   34.开办药品生产企业，须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准并发给《药品生产许可证》，凭《药品生产许可证》到工商行政管理部门办理登记注册。 Any newly established pharmaceutical manufacturer shall be subject to approval by the local drug regulatory agency of the government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Manufacturing Certificate, and, with the certificate, the manufacturer shall be registered with the administrative agency for industry and commerce.   35.《药品生产许可证》应当标明有效期和生产范围，到期重新审查发证。 The term of validation and the scope of manufacturing shall be noted in the Drug Manufacturing Certificate. For renewal of the certificate on expiration, reviewing and approval again is required.   36.药品监督管理部门批准开办药品生产企业，应当符合国家制定的药品行业发展规划和产业政策，防止重复建设。 When giving approval to the newly-established manufacturer, the drug regulatory agency shall see to it that the development programs and policies set by the State for the pharmaceutical industry shall be complied with so as to prevent duplicate construction.   37.开办药品生产企业，必须具备以下条件：（一）具有依法经过资格认定的药学技术人员、工程技术人员及相应的技术工人；（二）具有与其药品生产相适应的厂房、设施和卫生环境；（三）具有能对所生产药品进行质量管理和质量检验的机构、人员以及必要的仪器设备；（四）具有保证药品质量的规章制度。 Any drug manufacturer to be established shall meet the following requirements: (1) stuffed with legally qualified pharmaceutical and engineering professionals and the necessary technical workers;(2) provided with the premises, facilities, and clear environment required for drug manufacturing; (3) having quality management and control units and personnel capable of quality management of and testing for drugs to be produced and the necessary instruments and equipment; and (4) establishing rules and regulations to govern the quality of drugs.   38.药品生产企业必须按照国务院药品监督管理部门依据本法制定的《药品生产质量管理规范》组织生产。药品监督管理部门按照规定对药品生产企业是否符合《药品生产质量管理规范》的要求进行认证；对认证合格的，发给认证证书。 Drug manufacturers shall conduct production according to the Good Manufacturing Practice Products (GMP) formulated by the drug regulatory agency of the State Council based on this Law. The drug regulatory agency shall inspect a drug manufacturer as to its compliance with the GMP requirements and issue a certificate to the manufacturer passing the inspection.   39.除中药饮片的炮制外，药品必须按照国家药品标准和国务院药品监督管理部门批准的生产工艺进行生产，生产记录必须完整准确。 With the exception of the processing of prepared slices of  Chinese crude drugs, a drug shall be produced in  conformity  with  the  National Drug Standard and  with the production processes approved by  the  drug regulatory  agency of the State Council, and the production records shall be complete and accurate.   40.药品生产企业改变影响药品质量的生产工艺的，必须报原批准部门审核批准。 When drug manufacturers make any change in the production process t