1、1.中华人民共和国药品管理法 Drug Control Law of the Peoples Republic of China2.药品生产企业管理 control over drug manufacturers3.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 institutions5.药品管理 control over drugs6.药品包装的管理 control over drug packaging7.药品价格和广告的管理 control over drug p
2、rice and advertisement8.药品监督 inspection of drugs9.法律责任 legal liabilities10.药品标识labels or marks of the drugs11.假药counterfeit drugs12.劣药inferior drugs13.药品检验机构drug quality control laboratory14.药品的生产企业drug manufacturers15.经营企业drug distributors16.医疗机构medical institutions17.药品监督管理部门drug regulatory agency
3、18.药品批准证明文件drug approval documents19.行政处分administrative sanctions20.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 Certificate24.药品经营许可证Drug Supply Cert
4、ificate25.医疗机构制剂许可证Pharmaceutical Preparation Certificate for Medical Institution26.进口药品注册证书Import Drug License27.临床试验clinical trial28.新药证书New Drug Certificate29.药品批准文号Drug Approval Number30.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,
5、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 sup
6、ervision 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
7、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
8、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 Manuf
9、acturing 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 t
10、he 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 pharm
11、aceutical 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:
12、 (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 man
13、agement 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 conduc
14、t 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 manufac
15、turer 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 regu
16、latory 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 that may affect the drug quality, they shall submit the change to the original authority for reviewing
17、 and approval.41.生产药品所需的原料、辅料，必须符合药用要求。 Active pharmaceutical ingredients (API) and recipients for the manufacture of pharmaceutical products shall meet the requirements for medicinal use.42.药品生产企业必须对其生产的药品进行质量检验。Drug manufacturers shall perform quality test of their products.43.不符合国家药品标准或者不按照省、自治区、
18、直辖市人民政府药品监督管理部门制定的中药饮片炮制规范炮制的，不得出厂。 No products that do not meet the National Drug Standards or that are not produced according to the processing procedures for the prepared slices of Chinese crude drugs formulated by the drug regulatory agency of the government of a province, autonomous region, or
19、municipality directly under the Central Government may be released.44.经国务院药品监督管理部门或者国务院药品监督管理部门授权的省、自治区、直辖市人民政府药品监督管理部门批准，药品生产企业可以接受委托生产药品。 A drug manufacturer may not accept any contract production of drugs unless it is approved by the drug regulatory agency of the State Council, or by the drug reg
20、ulatory agency of the government of a province, autonomous region, or municipality directly under the Central Government authorized by the drug regulatory agency of the State Council.45.开办药品批发企业，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经营许可证.Any newly established drug wholesaler shall be subject to approv
21、al of the local drug agency of the government of the province, autonomous region or municipality directly under the Central Government and be granted the Drug Supply Certificate.46.开办药品零售企业，须经企业所在地县级以上地方药品监督管理部门批准并发给药品经营许可证 。Any newly established drug retailer shall be subject to approval and be gra
22、nted the above certificate by the local drug regulatory agency at or above the county level.47. 药品批发、零售企业凭药品经营许可证到工商行政管理部门办理登记注册。With the Drug Supply Certificate , the wholesaler and the retailer shall be registered with the administrative agency for industry and commerce.47.无药品经营许可证的，不得经营药品。 No one
23、 is permitted to distribute drugs without the certificate.48.药品经营许可证应当标明有效期和经营范围，到期重新审查发证。 The valid period and the scope of business shall be indicated in the Drug Supply Certificate. For renewal of the certificate upon expiration, reviewing and approval again is required.49.开办药品经营企业必须具备以下条件： （一）具有
24、依法经过资格认定的药学技术人员；（二）具有与所经营药品相适应的营业场所、设备、仓储设施、卫生环境；（三）具有与所经营药品相适应的质量管理机构或者人员；（四）具有保证所经营药品质量的规章制度。A drug distributor to be established shall meet the following requirements:(1) staffed with legally qualified pharmaceutical professionals;(2) provided with the business operation premises, equipment, ware
25、houses, and clear environment required for drug distribution;(3) having the quality control units or personnel adaptable the drugs to be distributed; and(4) establishing rules and regulations to govern the quality of the drugs to be distributed.50.药品经营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经营质量管理规范经营药品。Drug dist
26、ributors shall conduct business according to the Good Supply Practice for Pharmaceutical Products (GSP) set by the drug regulatory agency of the State Council based on this Law.51.药品监督管理部门按照规定对药品经营企业是否符合药品经营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。 The drug regulatory agency inspect a drug distributor as to its
27、compliance with the GSP requirements, and issue a certificate to the distributor passing the inspection.52.药品经营企业购进药品，必须建立并执行进货检查验收制度，验明药品合格证明和其他标识；不符合规定要求的，不得购进。 After receiving the drug purchased, drug distributors shall pass the established examination and acceptance system, and check the certifi
28、cate of drug quality, labels and others marks; no drugs that fail to meet the requirements are permitted to be purchased.53.药品经营企业购销药品，必须有真实完整的购销记录。Drug distributors shall keep a real and perfect records of purchasing and selling drugs.54.购销记录必须注明药品的通用名称、剂型、规格、批号、有效期、生产厂商、购（销）货单位、购（销）货数量、购销价格、购（销）货日
29、期及国务院药品监督管理部门规定的其他内容。 In the record shall be indicated the adopted name of drugs, dosage form, strength or size, batch number, date of expiry, manufacturer, purchaser (or seller), amount of the drug purchased (or sold), purchase or selling price, date of purchase (or sale) , and other items specifie
30、d by the drug regulatory agency of the State Council.55.药品经营企业销售中药材，必须标明产地。 Drug distributors shall indicate the habitat of Chinese crude drugs to be sold.56.药品经营企业必须制定和执行药品保管制度，采取必要的冷藏、防冻、防潮、防虫、防鼠等措施，保证药品质量。 A drug distributor shall pass the established system for drug storage, and take necessary m
31、easures to ensure drug quality, such as cold storing, protecting from being frozen and moisture and guarding against insects and rodents.57.药品入库和出库必须执行检查制度。 An examination system shall be followed for storing drugs in warehouse and releasing them from warehouse.58.城乡集市贸易市场可以出售中药材，国务院另有规定的除外。 Chinese
32、 crude drugs may be sold at fairs in urban and rural areas, except those otherwise specified by the State Council.59.城乡集市贸易市场不得出售中药材以外的药品，但持有药品经营许可证的药品零售企业在规定的范围内可以在城乡集市贸易市场设点出售中药材以外的药品。 No drugs other than the Chinese crude drugs may be sold at fairs in urban and rural areas, but drug retailers hol
33、ding the Drug Supply Certificate may, within the specified business scope, sell such drugs at the stores they set up at the fairs.60.医疗机构配制制剂，须经所在地省、自治区、直辖市人民政府卫生行政部门审核同意，由省、自治区、直辖市人民政府药品监督管理部门批准，发给医疗机构制剂许可证 。Dispensing pharmaceutical preparations by a medical institution shall be subject to reviewi
34、ng and permission by the health administration agency of the government of the province, autonomous region or municipality directly under the Central Government, and upon approval by the drug regulatory agency of the government. A Pharmaceutical Preparation Certificate for Medical Institution shall
35、be issued by the above drug regulatory agency.61.无医疗机构制剂许可证的医疗机构，不得配制制剂。 No medical institution is permitted to dispense pharmaceutical preparations without the Pharmaceutical Preparation Certificate for Medical Institution.62.医疗机构制剂许可证应当标明有效期，到期重新审查发证。 The term of validation shall be noted in the P
36、harmaceutical Preparation Certificate for Medical Institution. For renewal of the certificate upon expiration, reviewing and approval again is required.63.医疗机构配制的制剂，应当是本单位临床需要而市场上没有供应的品种，并须经所在地省、自治区、直辖市人民政府药品监督管理部门批准后方可配制。The pharmaceutical preparations to be dispensed by the medical institution sha
37、ll be those satisfying the clinic need of the institution but not available on the market. It shall be subject to approval in advance by the local drug regulatory agency of the government of the province, autonomous region or municipality directly under the Central Government.64.医疗机构配制的制剂，不得在市场销售。 N
38、o pharmaceutical preparations dispensed by medical institutions are permitted to be marketed.65.研制新药，必须按照国务院药品监督管理部门的规定如实报送研制方法、质量指标、药理及毒理试验结果等有关资料和样品，经国务院药品监督管理部门批准后，方可进行临床试验。A full description of a new drug research and development including the manufacturing process, quality specifications, resul
39、ts of pharmacological and toxicological study, and the related data as well as the samples shall, in accordance with the regulations of the drug regulatory agency of the State Council, be truthfully submitted to the above agency for reviewing and approval.66.完成临床试验并通过审批的新药，由国务院药品监督管理部门批准，发给新药证书。 Whe
40、n a new drug has gone through clinical trials and passed the reviewing, a New Drug Certificate shall be issued upon approval by the drug regulatory agency of the State Council.67.药物的非临床安全性评价研究机构和临床试验机构必须分别执行药物非临床研究质量管理规范、药物临床试验质量管理规范。 The institutions for non-clinical safety evaluation and study and
41、 for clinical study institutions shall respectively follow the Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP) and Good Clinical Practice (GCP).70.药品生产企业在取得药品批准文号后，方可生产该药品。 A drug manufacturer is permitted to produce the drug only after an approval number has been granted to it.71
42、. 药品必须符合国家药品标准。Drugs shall comply with the National Drug Standards.72.国务院药品监督管理部门颁布的中华人民共和国药典和药品标准为国家药品标准。The Pharmacopoeia of the Peoples Republic of China and the Drug Standards issued by the drug regulatory agency of the State Council shall serve as the National Drug Standards.73.国务院药品监督管理部门组织药典委
43、员会，负责国家药品标准的制定和修订。 The drug regulatory agency of the State Council shall organize a pharmacopoeia commission, which shall be responsible for formulating and revising the National Drug Standards.74.国务院药品监督管理部门的药品检验机构负责标定国家药品标准品、对照品。 The drug control institution affiliated to the drug regulatory agenc
44、y of the State Council is responsible for standardizing the National Drug Standard Substance and Reference Substance.75.药品生产企业、药品经营企业、医疗机构必须从具有药品生产、经营资格的企业购进药品；但是，购进没有实施批准文号管理的中药材除外。 Drug manufacturers, drug distributors and medical institutions shall purchase drugs from pharmaceutical enterprises,
45、which are qualified for production and distribution, with the exception of the Chinese crude drugs in which no control by approval number is exercised.76.国家对麻醉药品、精神药品、医疗用毒性药品、放射性药品，实行特殊管理。The State exercises special control over narcotic drugs, psychotropic substances, toxic drugs for medical use an
46、d radioactive pharmaceuticals.77.国家实行中药品种保护制度。The State adopts a protection system for certain traditional Chinese medicines.78.国家对药品实行处方药与非处方药分类管理制度。 The State adopts a system of classified management for prescription and non-prescription drugs. 79.药品进口，须经国务院药品监督管理部门组织审查，经审查确认符合质量标准、安全有效的，方可批准进口，并发
47、给进口药品注册证书。 Reviewing the drugs to be imported shall come of the jurisdiction of the drug regulatory agency of the State Council. A drug is permitted to be imported only upon approval granted after confirming that it conforms to the quality, safely and efficiency through examination, and a drug impor
48、tation license shall be issued.80.国家实行药品储备制度。The State adopts a policy for drug storage for future use.81.国内发生重大灾情、疫情及其他突发事件时，国务院规定的部门可以紧急调用企业药品。When major disasters, epidemic situations or other emergencies occur in the country, the department designated by the State Council may allocate drugs from
49、 the enterprises to meet the urgent need.82. 禁止生产（包括配制） 、销售假药。 Production (including dispensing) and distribution of counterfeit drugs are prohibited.83.有下列情形之一的，为假药： A drug falling into the following categories is deemed as a counterfeit drug:（一）药品所含成份与国家药品标准规定的成份不符的； The ingredients in the drug are different from those specified by the National Drug Standards; （二）以非药品冒充药品或者以他种药品冒充此种药品的。 It is not the same drug which is claimed by its name or in reality it is not a drug at all. 84.有下列情形之一的药品，按假药论处： A drug falling into the following catego
