中华人民共和国药品管理法中英对照.doc

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1、中华人民共和国药品管理法中英对照中华人民共和国药品管理法LAW OF THE PEOPLES 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,

2、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 de

3、velops 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 tradi

4、tional 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 pr

5、oduction 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 o

6、r municipality under the direct control of the Central Government, which shall issue the Drug-production Enterprise Licence. 无药品生产企业许可证的工商行政管理部门不得发给营业执照。 Without a Drug-production Enterprise Licence, the department administering industry and commerce may not issue a Business Licence. 药品生产企业许可证应当规定有效

7、期，到期重新审查发证。具体办法由国务院卫生行政部门规定。 The Drug-production Enterprise Licence shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be determined by the State Council department responsible for health administration.

8、 第五条开办药品生产企业必须具备以下条件： Article 5 The establishment of an enterprise to produce drugs must satisfy the following conditions: （一）具有与所生产药品相适应的药师或者助理工程师以上技术人员及技术工人。 (1) It must employ pharmacists, technical personnel above the rank of assistant engineer and technical workers appropriate to the drug produ

9、ction carried out by the enterprise. 中药饮片加工企业没有药师或者助理工程师以上技术人员，配备熟悉药性并经县级以上卫生行政部门审查登记的药工人员。 Where an enterprise engaged in the processing of traditional Chinese medicine does not have a pharmacist or technical personnel of a rank above that of assistant engineer, it may use drug industry personnel w

10、ith an intimate knowledge of drugs who have been examined and registered by a department of health administration above the county level. （二）具有与所生产药品相适应的厂房、设施和卫生环境。 (2) It must have a factory building, facilities and a hygienic environment appropriate to its production of drugs. （三）具有能对所生产药品进行质量检验的机

11、构或者人员以及必要的仪器设备。 (3) It must have an organisation or personnel capable of carrying out quality examinations on the drugs produced as well as the necessary instruments and equipment. 第六条药品必须按照工艺规程进行生产，生产记录必须完整准确。 Article 6 The production of drugs must be carried out in accordance with the correct tech

12、nological procedures; production records shall be kept in detail and accurately. 中药饮片的炮制必须符合中华人民共和国药典,或者省、自治区、直辖市卫生行政部门制定的炮制规范的规定。 The preparation of Chinese medicines shall be in accordance with the Pharmacopoeia of the Peoples Republic of China, or in accordance with the Preparation Standards laid

13、 down by the department administering health in that province, autonomous region or municipality under the direct control of the Central Government. 第七条生产药品所需的原料、辅料以及直接接触药品的容器和包装材料，必须符合药用要求。 Article 7 Raw materials and supplementary materials required for the production of drugs as well as container

14、s and packing materials which come into direct contact with drugs shall meet standards required for pharmaceutical use. 第八条药品出厂前必须经过质量检验；不符合标准的，不得出厂。 Article 8 Before drugs leave the factory, they must pass a quality examination. If they do not reach the required standard, they must not leave the fa

15、ctory. 第九条药品生产企业必须按照国务院卫生行政部门制定的药品生产质量管理规范的要求，制定和执行保证药品质量的规章制度和卫生要求。 Article 9 Drug-producing enterprises must formulate and implement a system of rules and regulations and hygiene requirements to guarantee the quality of drugs in accordance with the requirements of the Standards for the Administrat

16、ion of Drug-production Quality laid down by the department of the State Council administering health. 第三章药品经营企业的管理 CHAPTER III ADMINISTRATION OF DRUG-HANDLING ENTERPRISES 第十条开办药品经营企业必须由所在地药品生产经营主管部门审查同意，经县级以上卫生行政部门审核批准，并发给药品经营企业许可证。无药品经营企业许可证的，工商行政管理部门不得发给营业执照。 Article 10 The establishment of a drug

17、-handling enterprise must be examined and agreed to by the department responsible for drug production and handling in the place where the enterprise is situated, and must be examined and approved by a health department at county level or above, which will issue a Drug-handling Enterprise Licence, wi

18、thout which the department administering industry and commerce may not issue a Business Licence. 药品经营企业许可证应当规定有效期，到期重新审查发证。具体办法由国务院卫生行政部门规定。 A Drug-handling Enterprise Licence shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. S

19、pecific procedures will be determined by the department of the State Council administering health. 第十一条开办药品经营企业必须具备以下条件： Article 11 The establishment of a drug-handling enterprise must satisfy the following conditions: （一）具有与所经营药品相适应的药学技术人员。 (1) It must employ pharmaceutical technicians appropriate

20、to the medicines handled. 经营中药的企业和兼营药品的企业没有药学技术人员.配备熟悉所经营药品的药性并经县级以上卫生行政部门审查登记的药工人员。 Where an enterprise engaged in the handling of Chinese medicines or partly engaged in handling drugs does not have a pharmaceutical technician it may use drug industry personnel with an intimate knowledge of the med

21、icinal nature of the drugs handled who have been examined and registered by a department administering health at above county level. （二）具有与所经营药品相适应的营业场所、设备、仓储设施和卫生环境。 (2) It must have business premises, equipment, storage facilities and a hygienic environment appropriate to the drugs handled. 第十二条收购

22、药品，必须进行质量验收；不合格的，不得收购。 Article 12 On purchasing drugs, quality examinations must be carried out; if the drugs do not come up to standard, they may not be purchased. 第十三条销售药品必须准确无误，并正确说明用法、用量和注意事项； Article 13 In selling drugs, it is necessary to be exact and accurate; the method of use, dosage and po

23、ints to note must be explained precisely. 调配处方必须经过核对，对处方所列药品不得擅自更改或者代用。 In making up prescriptions, checks must be carried out; the drugs itemised in the prescription must not be altered or substituted without authorisation. 对有配伍禁忌或者超剂量的处方应当拒绝调配；必要时经处方医生更正或者重新签字，方可调配。 Where a prescription contains i

24、ngredients that are incompatible or amounts of ingredients in excess of the proper dosage, a request to make up the prescription shall be refused; if necessary, after the prescribing doctor has corrected it and signed it again, it may be made up. 销售地道中药材，必须标明产地。 Where authentic Chinese medicines are

25、 sold, they shall be labelled to indicate the place of origin. 第十四条药品仓库必须制定和执行药品保管制度，采取必要的冷藏、防潮、防虫、防鼠等措施。 Article 14 Drug warehouses shall lay down and implement a system of rules and regulations for the storage of drugs and take measures necessary in relation to cold storage, protection against dam

26、p, and protection from insects, rodents, etc. 药品入库出库必须执行检查制度。 An inspection system shall be put into effect in relation to drugs which are brought into or removed from the warehouse. 第十五条城乡集市贸易市场可以出售中药材，国家另有规定的除外。 Article 15 Chinese medicinal materials may be sold in town and country trading markets

27、 except where otherwise stipulated by the State. 城乡集市贸易市场不得出售中药材以外的药品持有药品经营企业许可证的除外。 Drugs other than Chinese medicinal materials may not be sold in the trading markets of country towns, unless a Drug-handling Enterprise Licence is held. 第四章医疗单位的药剂管理 CHAPTER IV ADMINISTRATION OF DRUGS IN MEDICAL TRE

28、ATMENT UNITS 第十六条医疗单位必须配备与其医疗任务相适应的药学技术人员，非药学技术人员不得直接从事药剂技术工作。 Article 16 Medical treatment units must be staffed with the number of pharmaceutical technicians appropriate to their medical treatment responsibilities. Personnel who are not pharmaceutical technicians may not be engaged directly in pha

29、rmaceutical technical work. 第十七条医疗单位配制制剂必须经所在省、自治区、直辖市卫生行政部门审查批准，并发给制剂许可证。 Article 17 The making up of drugs by medical treatment units must be examined and approved by the department in charge of health administration in the province, autonomous region or municipality under the direct control of th

30、e Central Government where the unit is situated, which will issue a Dispensing Licence. 制剂许可证应当规定有效期，到期重新审查发证。具体办法由国务院卫生行政部门规定。 A Dispensing Licence shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be

31、laid down by the department of the State Council administering health. 第十八条医疗单位配制制剂必须具有能够保证制剂质量的设施、检验仪器和卫生条件。 Article 18 A medical treatment unit which makes up drugs must have adequate facilities, instruments for examination and hygienic conditions to ensure the quality of the drugs prepared. 第十九条医

32、疗单位配制的制剂，必须根据临床需要并按照规定进行质量检验；合格的，凭医生处方使用。 Article 19 The drugs made up by medical treatment units must comply with clinical requirements and, in accordance with regulations, quality examinations must be conducted. They are only to be used if up to quality and on a doctors prescription. 医疗单位配制的制剂不得在市

33、场销售。 Drugs made up by medical treatment units may not be sold on the market. 第二十条医疗单位购进药品，必须执行质量验收制度。 Article 20 When a medical treatment unit purchases drugs, it must implement a system of checking the quality on delivery. 第五章药品的管理 CHAPTER V DRUG ADMINISTRATION 第二十一条国家鼓励研究、创制新药。 Article 21 The Stat

34、e encourages research into and development of new drugs. 研制新药必须按照规定向国务院卫生行政部门或者省、自治区、直辖市卫生行政部门报送研制方法、质量指标、药理及毒理试验结果等有关资料和样品。经批准后，方可进行临床试验或者临床验证。 Where a new drug has been researched and developed, in accordance with the regulations, a report must be submitted, with samples, to the State Council depa

35、rtment administering health or the department of the province, autonomous region or municipality under the direct control of the Central Government administering health, giving details of the method of research and development, quality norms, pharmacological and toxicological tests and other relevan

36、t data. Only after it has been approved may clinical tests or clinical verifications be carried out. 完成临床试验或者临床验证并通过鉴定的新药由国务院卫生行政部门批准发给证书。 Where a new drug has completed its clinical tests or clinical verification and has passed an appraisal it may be approved by the department of the State Council

37、administering health, which will issue a certificate. 第二十二条生产新药，必须经国务院卫生行政部门批准，并发给批准文号。但是，生产中药饮片除外。 Article 22 The production of new drugs must be approved by the department of the State Council administering health which will issue an approval number. However, the production of Chinese medicines sl

38、iced and prepared for decoction is excepted. 生产已有国家标准或者省、自治区、直辖市标准的药品，必须经省、自治区、直辖市卫生行政部门征求同级药品生产经营主管部门意见后审核批准，并发给批准文号。但是，生产中药饮片除外。 The production of drugs for which there is already a national drug standard, or a drug standard of a province, autonomous region or municipality under the direct control

39、 of the Central Government, must be examined and approved by the department responsible for health administration in the relevant province, autonomous region or municipality under the direct control of the Central Government after seeking the opinion of the corresponding authority responsible for th

40、e drug-producing enterprise. An approval number will be issued. However, the production of Chinese medicines sliced and prepared for decoction is excepted. 第二十三条药品必须符合国家药品标准或者省、自治区、直辖市药品标准。 Article 23 Drugs must comply with the national drug standard, or with the drug standard of the province, auton

41、omous region or municipality under the direct control of the Central Government. 国务院卫生行政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 drug standards promulgated by the department of the State Council administering health are the national drug standards. 国务院卫生行政部

42、门的药典委员会负责组织国家药品标准的制定和修订。 The Pharmacopoeia Committee of the department of the State Council administering health is the body responsible for handling the setting and revision of national drug standards. 第二十四条国务院卫生行政部门和省、自治区、直辖市卫生行政部门可以成立药品审评委员会，对新药进行审评，对已经生产的药品进行再评价。 Article 24 The State Council dep

43、artment responsible for health administration and the departments of the provinces, autonomous regions and municipalities under the direct control of the Central Government administering health may establish a Drug Evaluation Committee to evaluate new drugs and re-evaluate drugs already being produc

44、ed. 第二十五条国务院卫生行政部门对已经批准生产的药品，应当组织调查；对疗效不确、不良反应大或者其他原因危害人民健康的药品，应当撤销其批准文号。 Article 25 The department of the State Council responsible for administering health shall organise investigation into drugs already approved for production; where the efficacy of a drug is not reliable, the side-effects to a d

45、rug are great, or a drug is for any other reason harmful to peoples health, the approval number shall be revoked. 已被撤销批准文号的药品不得继续生产、销售；已经生产的由当地卫生行政部门监督销毁或者处理。 Where the approval number of a drug has been revoked, production and sale of the drug may not be continued; what has already been produced sh

46、all be burnt or disposed of under the supervision of the local department administering health. 第二十六条禁止进口疗效不确、不良反应大或者其他原因危害人民健康的药品。 Article 26 It is forbidden to import a drug if its efficacy is not reliable, if its side-effects are great, or it is for any other reason harmful to peoples health. 第二十

47、七条首次进口的药品，进口单位必须提供该药品的说明书、质量标准、检验方法等有关资料和样品以及出口国（地区）批准生产的证明文件，经国务院卫生行政部门批准，方可签订进口合同。 Article 27 Where a drug is being imported for the first time, the importing unit must submit a written description of the drug, details of its quality standards, testing and other relevant data, samples, and documen

48、tation proving that the exporting country (place) has approved production. Only when the approval of the department of the State Council administering health has been obtained may the import contract be signed. 第二十八条进口的药品，必须经国务院卫生行政部门授权的药品检验机构检验；检验合格的，方准进口。 Article 28 Imported drugs must be examined by a drug examination body so authorised by the State Council department responsible for health administration. Only when a drug passes examination will importation be permitted. 医疗单位临床急需或者个人自用进口的少量药品按照海关的规定办理进口手续。 The importation of a small