手机版
第五章 药品管理
Chapter V Pharmaceutical Administration
第二十九条 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。药物临床试验机构资格的认定办法，由国务院药品监督管理部门、国务院卫生行政部门共同制定。
Article 29 When producing a new medicine, it is necessary to submit information about the methods of production, quality indices, pharmacological and toxicological testing results, and other related materials and sales as required by the pharmaceutical supervisory and administrative department of the State Council, only after whose approval can clinical tests be carried out. Certifying measures for clinical test units shall be jointly formulated by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of health under the State Council.
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。
A new medicine which has completed its clinical tests and been approved after appraisal shall be issued a certificate of new medicine by the pharmaceutical supervisory and administrative department under the State Council.
第三十条 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。
Article 30 The pharmaceutical non-clinical safety appraisal and research units and the clinical test units must respectively carry out the quality control standard for pharmaceutical non-clinical research and the quality control standard for pharmaceutical clinical test.
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由国务院确定的部门制定。
The quality control standard for pharmaceutical non-clinical research and the quality control standard for pharmaceutical clinical test shall be formulated by the department appointed by the State Council.
第三十一条 生产新药或者已有国家标准的药品的，须经国务院药品监督管理部门批准，并发给药品批准文号；但是，生产没有实施批准文号管理的中药材和中药饮片除外。
Article 31 A new medicine or medicine standardized by the State can be put into production only after the pharmaceutical supervisory and administrative department under the State Council has approved it and issued a registered document of approval. However, this does not apply to the production of traditional Chinese medicinal herbs and traditional Chinese medicine prepared in ready-to-use forms that are not controlled under a registered document of approval.
实施批准文号管理的中药材、中药饮片品种目录由国务院药品监督管理部门会同国务院中医药管理部门制定。
For those traditional Chinese medicinal herbs and traditional Chinese medicines prepared in ready-to-use forms that are controlled with registered document of approval, the pharmaceutical supervisory and administrative department under the State Council and the administrative department of traditional Chinese medicines under the State Council shall jointly formulate their type catalogue.
药品生产企业在取得药品批准文号后，方可生产该药品。
Pharmaceutical producing enterprises can produce medicine only after obtaining the registered document of approval.
第三十二条 药品必须符合国家药品标准。中药饮片依照本法第十条第二款的规定执行。
Article 32 Pharmaceuticals must meet the pharmaceutical standards of the State. Article 10 (2) of this Law shall be applied to traditional Chinese medicines prepared in ready-to-use forms.
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 People's Republic of China" and the pharmaceutical standards promulgated by the pharmaceutical supervisory and administrative department under the State Council shall be the State pharmaceutical standards.
国务院药品监督管理部门组织药典委员会，负责国家药品标准的制定和修订。
The Pharmacopoeia Committee organized by the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the formulation and revision of the State pharmaceutical standards.
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 pharmaceutical inspection institutions of the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the designation of State standard and contrastive pharmaceuticals.
第三十三条 国务院药品监督管理部门组织药学、医学和其他技术人员，对新药进行审评，对已经批准生产的药品进行再评价。
Article 33 The pharmaceutical supervisory and administrative department under the State Council may organize pharmaceutical, medicinal and other technological personnel to carry out examination and evaluation of new medicines, and to reevaluate medicines already placed into production.
第三十四条 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。
Article 34 Pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical organizations must purchase pharmaceuticals from the qualified enterprises with the certificates for production and trade of pharmaceuticals. However, this does not apply to the purchase of the traditional Chinese medicinal herbs which are not controlled under the registered document of approval.
第三十五条 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。管理办法由国务院制定。
Article 35 For narcotics, psychotropic substances, toxic drugs for medicinal use, and radioactive drugs, the State Council shall formulate administrative measures to carry out special control.
第三十六条 国家实行中药品种�；ぶ贫�。具体办法由国务院制定。
Article 36 The State Council shall formulate detailed measures to carry out a protection system for the categorization of traditional Chinese medicines.
第三十七条 国家对药品实行处方药与非处方药分类管理制度。具体办法由国务院制定。
Article 37 The State Council shall formulate detailed measures to carry out a classified control system for prescription pharmaceuticals and non-prescription pharmaceuticals.
第三十八条 禁止进口疗效不确、不良反应大或者其他原因危害人体健康的药品。
Article 38 Import of medicines whose curative effects are uncertain or poor, or which produce adverse reactions or have other harmful effects on people's health shall be prohibited.
第三十九条 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，并发给进口药品注册证书。
Article 39 The import of medicines must go through examinations organized by the pharmaceutical supervisory and administrative department under the State Council. Those confirmed to conform to quality standards to be safe and effective can be approved to be imported and shall be issued a registered certificate for import.
医疗单位临床急需或者个人自用进口的少量药品，按照国家有关规定办理进口手续。
Medicines to be imported in small quantities for urgent clinical needs by medical organizations or for personal use shall go through import formalities according to relevant regulations of the State.
第四十条 药品必须从允许药品进口的口岸进口，并由进口药品的企业向口岸所在地药品监督管理部门登记备案。海关凭药品监督管理部门出具的《进口药品通关单》放行。无《进口药品通关单》的，海关不得放行。
Article 40 Pharmaceuticals must be imported through the ports which allow the import of pharmaceuticals, and the pharmaceutical import enterprise shall submit a report to the pharmaceutical supervisory and administrative department of the place where the port is located. Customs shall rely on the Import Pharmaceuticals Customs Form issued by the pharmaceutical supervisory and administrative department to proceed. Those without the Import Pharmaceuticals Customs Form shall not be permitted to pass through customs.
口岸所在地药品监督管理部门应当通知药品检验机构按照国务院药品监督管理部门的规定对进口药品进行抽查检验，并依照本法第四十一条第二款的规定收取检验费。
The pharmaceutical supervisory and administrative department of the place where the port is located shall notify the pharmaceutical inspection institution to carry out selective examinations and inspections on the imported pharmaceuticals according to the regulations stipulated by the pharmaceutical supervisory and administrative department under the State Council, and to collect inspection fees according to Article 41(2) of this Law.
允许药品进口的口岸由国务院药品监督管理部门会同海关总署提出，报国务院批准。
The nomination of the ports allowable for import of pharmaceuticals shall be jointly conducted by the pharmaceutical supervisory and administrative department under the State Council and the Customs Headquarters, and be reported to the State Council for approval.
第四十一条 国务院药品监督管理部门对下列药品在销售前或者进口时，指定药品检验机构进行检验；检验不合格的，不得销售或者进口：
Article 41 The pharmaceutical supervisory and administrative department under the State Council shall appoint inspection institutions to carry out inspections before the sale and import of the following pharmaceuticals. Those having not passed the inspection shall not be allowed to be sold or imported.
（一）国务院药品监督管理部门规定的生物制品；
(1) Bio-products prescribed by the pharmaceutical supervisory and administrative department of the State Council.
（二）首次在中国销售的药品；
(2) Pharmaceuticals to be sold for the first time in China.
（三）国务院规定的其他药品。
(3) Other pharmaceuticals prescribed by the State Council.
前款所列药品的检验费项目和收费标准由国务院财政部门会同国务院价格主管部门核定并公告。
The inspection fee and charge standards for the above-mentioned pharmaceuticals shall be jointly checked, ratified and promulgated by the financial department under the State Council and the competent authority of price control under the State Council.
检验费收缴办法由国务院财政部门会同国务院药品监督管理部门制定。
The measures for the collection of inspection fees shall be jointly formulated by the financial department under the State Council and the pharmaceutical supervisory and administrative department under the State Council.
第四十二条 国务院药品监督管理部门对已经批准生产或者进口的药品，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体健康的药品，应当撤销批准文号或者进口药品注册证书。
Article 42 The pharmaceutical supervisory and administrative department under the State Council shall organize investigations on medicines which have been approved for production or import. It shall revoke the registered documents of approval or the registered certificate of import if it discovers that the curative effects of the medicines are uncertain or poor, that they produce serious adverse reactions, or that for other reasons they are harmful to people's health.
已被撤销批准文号或者进口药品注册证书的药品，不得生产或者进口、销售和使用；已经生产或者进口的，由当地药品监督管理部门监督销毁或者处理。
The medicines whose registered documents of approval or registered certificate of import have been revoked shall not be allowed to be produced, imported, sold or used. Those which have already been produced or imported shall be destroyed or disposed of under the supervision of the local pharmaceutical supervisory and administrative departments.
第四十三条 国家实行药品储备制度。
Article 43 A pharmaceutical reserve system shall be carried out by the State.
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。
In case of serious disasters, plagues and other sudden emergencies, the department prescribed by the State Council can requisite the pharmaceuticals of enterprises to deal with such emergencies.
第四十四条 对国内供应不足的药品，国务院有权限制或者禁止出口。
Article 44 The State Council shall have the power to restrict or prohibit the export of the pharmaceuticals which are in short supply in the domestic market.
第四十五条 进口、出口麻醉药品和国家规定范围内的精神药品，必须持有国务院药品监督管理部门发给的《进口准许证》、《出口准许证》。
Article 45 Import or export licenses issued by the pharmaceutical supervisory and administrative department under the State Council are required for the import or export of narcotics and psychotropic substances falling within the restricted scope prescribed by the State.
第四十六条 新发现和从国外引种的药材，经国务院药品监督管理部门审核批准后，方可销售。
Article 46 Newly discovered domestic medicinal plants or medicinal plants introduced from abroad may be sold only after they have been examined and approved by the pharmaceutical supervisory and administrative department under the State Council.
第四十七条 地区性民间习用药材的管理办法，由国务院药品监督管理部门会同国务院中医药管理部门制定。
Article 47 Measures for controlling medicinal materials traditionally used by local people in certain regions shall be jointly formulated by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of traditional Chinese medicines under the State Council.
第四十八条 禁止生产（包括配制，下同）、销售假药。有下列情形之一的，为假药：
Article 48 The production (including preparation, which also applies to the following) and sale of fake medicines are prohibited. A fake medicine has any one of the following characteristics:
（一）药品所含成份与国家药品标准规定的成份不符的；
(1) Its components are different from those prescribed by state pharmaceutical standards.
（二）以非药品冒充药品或以他种药品冒充此种药品的。
(2) A non-medical substance is passed off as a medicine, or one medicine is passed off as another.
有下列情形之一的药品，按假药论处：
A medicine shall be handled as fake medicine in any of the following cases:
（一）国务院药品监督管理部门规定禁止使用的；
(1) Where the use of the medicine has been prohibited by the pharmaceutical supervisory and administrative department under the State Council;
（二）依照本法必须批准而未经批准生产、进口，或者依照本法必须检验而未经检验即销售的；
(2) Where the medicine is produced and imported without an approval dictated according to this Law, or the medicine is sold without being inspected as dictated according to this Law;
（三）变质的；
(3) Where the medicine has deteriorated; or
（四）被污染的；
(4) Where the medicine has been contaminated;
（五）使用依照本法必须取得批准文号而未取得批准文号的原料药生产的；
(5) Where the medicine has been produced with pharmaceutical materials without obtaining the dictated registration document of approval for the materials.
（六）所标明的适应症或者功能主治超出规定范围的。
(6) Where the indications or the functions marked on the labels of the pharmaceuticals do not fall within the prescribed scope.
第四十九条 禁止生产、销售劣药。药品成份的含量不符合国家药品标准的，为劣药。
Article 49 It is prohibited to produce and sell medicines of inferior quality, referring to the medicines whose components do not conform in quantity to that required by State pharmaceutical standards.
有下列情形之一的药品，按劣药论处：
A medicine shall be handled as medicine of inferior quality in any of the following cases:
（一）未标明有效期或者更改有效期的；
(1) An expiry date is not indicated or is altered; or
（二）不注明或者更改生产批号的；
(2) A registration number is not indicated or is altered; or
（三）超过有效期的；
(3) The medicine has passed its expiration date; or
（四）直接接触药品的包装材料和容器未经批准的；
(4) The packages and containers which have direct contact with pharmaceuticals have not obtained approval; or
（五）擅自添加着色剂、防腐剂、香料、矫味剂及辅料的；
(5) The medicine has been added presumptuously with color or preservative additives, spice, disguising odor or supplementary materials; or
（六）其他不符合药品标准规定的。
(6) The medicine fails to meet the prescribed standards in other respects.
第五十条 列入国家药品标准的药品名称为药品通用名称。已经作为药品通用名称的，该名称不得作为药品商标使用。
Article 50 The names of the pharmaceuticals listed in the State pharmaceutical standards are the generic names of the pharmaceuticals. Those names that have become the generic names of pharmaceuticals shall not be used as trademarks of pharmaceuticals.
第五十一条 药品生产企业、药品经营企业和医疗机构直接接触药品的工作人员，必须每年进行健康检查�；加写静』蛘咂渌赡芪廴疽┢返募膊〉�，不得从事直接接触药品的工作。
Article 51 Personnel in pharmaceutical producing or trading enterprises and in medical organizations who have direct contact with medicines must undergo an annual medical examination. Persons who have contracted contagious diseases or any other disease which may contaminate the medicine shall not be allowed to engage in any work which has direct contact with pharmaceuticals.
第六章 药品包装的管理
Chapter VI Administration on Pharmaceutical Packaging
第五十二条 直接接触药品的包装材料和容器，必须符合药用要求，符合保障人体健康、安全的标准，并由药品监督管理部门在审批药品时一并审批。
Article 52 The pharmaceutical packaging materials and containers which have direct contact with pharmaceuticals must meet the requirements of medicinal use, conform with the standards of protecting people's health and safety, and obtain the approval of the pharmaceutical supervisory and administrative departments at the same time as the approval of the pharmaceutical product.
药品生产企业不得使用未经批准的直接接触药品的包装材料和容器。
Pharmaceutical producing enterprises shall use the packaging materials and containers which have direct contact with the pharmaceuticals only after they have obtained approval for them.
对不合格的直接接触药品的包装材料和容器，由药品监督管理部门责令停止使用。
The pharmaceutical supervisory and administrative departments shall stop the use of those unqualified packaging materials and containers which have direct contact with the pharmaceuticals.
第五十三条 药品包装必须适合药品质量的要求，方便储存、运输和医疗使用。
Article 53 Packaging must meet the specific quality requirements of the pharmaceuticals and facilitate their storage, transportation and medical use.
发运中药材必须有包装。在每件包装上，必须注明品名、产地、日期、调出单位，并附有质量合格的标志。
Traditional Chinese medicinal materials must be packaged before transportation. There must appear on the package the name of the medicine, place of production, date, name of the consignor, and an indication showing that the quality of the medicine meets standards.
第五十四条 药品包装必须按照规定印有或者贴有标签并附有说明书。
Article 54 Packages of pharmaceuticals must be labeled and include directions for use in accordance with the regulations.
标签或者说明书上必须注明药品的通用名称、成份、规格、生产企业、批准文号、产品批号、生产日期、有效期、适应症或者功能主治、用法、用量、禁忌、不良反应和注意事项。
The label or directions must indicate the generic name of the medicine, components, specifications, the producer, registration number, batch number of the product, production date, expiry date, indications or major functions, directions for use, dosage, restrictions, adverse reactions and precautions.
麻醉药品、精神药品、医疗用毒性药品、放射性药品、外用药品和非处方药的标签，必须印有规定的标志。
Special indications must be printed as required on the labels of narcotics, psychotropic substances, toxic drugs for medical use, radioactive drugs, medicines for external use and non-prescriptive pharmaceuticals.
第七章 药品价格和广告的管理
Chapter VII Administration of the Prices and Advertising of Pharmaceuticals
第五十五条 依法实行政府定价、政府指导价的药品，政府价格主管部门应当依照《中华人民共和国价格法》规定的定价原则，依据社会平均成本、市场供求状况和社会承受能力合理制定和调整价格，做到质价相符，消除虚高价格，�；び靡┱叩恼崩�。
Article 55 For pharmaceuticals controlled by the fixed and directive pricing system of the government, the competent authority of pricing of the government shall fix and adjust the price with reason in conformity with the principles for fixing prices as prescribed by the Price Law of the PRC and according to the considerations of societal average costs, market supply and demand, and the level of societal tolerance to achieve accord between quality and price, to avoid excessive prices, and to safeguard the due interests of the users of the pharmaceuticals.
药品的生产企业、经营企业和医疗机构必须执行政府定价、政府指导价，不得以任何形式擅自提高价格。
Pharmaceutical producing enterprises, trading enterprises and medical organizations must carry out the fixed price and directive price system of the government, and shall not presumptuously raise prices in any form.
药品生产企业应当依法向政府价格主管部门如实提供药品的生产经营成本，不得拒报、虚报、瞒报。
Pharmaceutical producing enterprises shall provide the competent authority of pricing of the government with the producing and trading costs of pharmaceuticals and shall not refuse to report, make a false report or withhold the truth in such a report.
第五十六条 依法实行市场调节价的药品，药品的生产企业、经营企业和医疗机构应当按照公平、合理和诚实信用、质价相符的原则制定价格，为用药者提供价格合理的药品。
Article 56 For the pharmaceuticals whose prices are to be adjusted by the market, the pharmaceutical producing enterprises, trading enterprises, and medical organizations shall fix the price in conformity with the principles of fairness, rationality, honesty, good faith and accord between quality and price to provide the users of the pharmaceuticals with reasonable prices.
药品的生产企业、经营企业和医疗机构应当遵守国务院价格主管部门关于药价管理的规定，制定和标明药品零售价格，禁止暴利和损害用药者利益的价格欺诈行为。
Pharmaceutical producing enterprises, trading enterprises and medical organizations shall abide by the regulations concerning the control on prices of pharmaceuticals prescribed by the competent authority of pricing under the State Council, shall fix and mark the retail prices of pharmaceuticals, and shall avoid sudden excessive profits and deceptive acts on pricing which will harm the interests of the users of the pharmaceuticals.
第五十七条 药品的生产企业、经营企业、医疗机构应当依法向政府价格主管部门提供其药品的实际购销价格和购销数量等资料。
Article 57 Pharmaceutical producing enterprises, trading enterprises and medical organizations shall, in accordance with this Law, provide the competent authority of pricing of the government with information such as the actual purchasing and selling prices and quantities of the pharmaceuticals.
第五十八条 医疗机构应当向患者提供所用药品的价格清单；医疗保险定点医疗机构还应当按照规定的办法如实公布其常用药品的价格，加强合理用药的管理。具体办法由国务院卫生行政部门规定。
Article 58 Medical organizations shall provide the patient with the price list of the pharmaceuticals used. Medical organizations appointed by medical insurance shall faithfully promulgate the prices of frequently used pharmaceuticals according to prescribed measures to enhance the reasonable use of pharmaceuticals.
第五十九条 禁止药品的生产企业、经营企业和医疗机构在药品购销中帐外暗中给予、收受回扣或者其他利益。
Article 59 Pharmaceutical producing enterprises, trading enterprises and medical organizations are prohibited to give or receive secret commissions and other benefits during the purchasing and selling of pharmaceuticals.
禁止药品的生产企业、经营企业或者其代理人以任何名义给予使用其药品的医疗机构的负责人、药品采购人员、医师等有关人员以财物或者其他利益。禁止医疗机构的负责人、药品采购人员、医师等有关人员以任何名义收受药品的生产企业、经营企业或者其代理人给予的财物或者其他利益。
Pharmaceutical producing enterprises, trading enterprises or their representatives are prohibited to give any property or other benefits under any name to the principals, buyers of pharmaceuticals, physicians and other relevant persons in the medical organizations where their pharmaceuticals are used. The principals, buyers of pharmaceuticals, physicians and other relevant persons are prohibited from receiving any property or other benefits under any name from pharmaceutical producing enterprises, trading enterprises or their agents.
第六十条 药品广告须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准，并发给药品广告批准文号；
Article 60 Advertisements of pharmaceuticals must be approved and issued a registration number of advertisement by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government of the place where the enterprises are located.
未取得药品广告批准文号的，不得发布。
In the absence of such registration numbers, advertisements for any medicines may not be placed.
处方药可以在国务院卫生行政部门和国务院药品监督管理部门共同指定的医学、药学专业刊物上介绍，但不得在大众传播媒介发布广告或者以其他方式进行以公众为对象的广告宣传。
Prescription pharmaceuticals may be introduced in medicinal and pharmaceutical magazines jointly appointed by the administrative department of health under the State Council and the pharmaceutical supervisory and administrative department under the State Council, but shall not be advertised through mass media or publicized in any other form to the public.
第六十一条 药品广告的内容必须真实、合法，以国务院药品监督管理部门批准的说明书为准，不得含有虚假的内容。
Article 61 The contents of pharmaceutical advertisement must be true, legitimate, and be based on the directions for use approved by the pharmaceutical supervisory and administrative department under the State Council, and be also free of falsehood.
药品广告不得含有不科学的表示功效的断言或者保证；不得利用国家机关、医药科研单位、学术机构或者专家、学者、医师、患者的名义和形象作证明。
Advertisements of pharmaceuticals shall not contain any unscientific assertion or guarantee on effects, and shall not be endorsed using the names and images of government bodies, pharmaceutical scientific research units, academic organizations, experts, scholars, physicians and sufferers.
非药品广告不得有涉及药品的宣传。
The advertisements of non-pharmaceuticals shall not be involved in the publicizing of pharmaceuticals.
第六十二条 省、自治区、直辖市人民政府药品监督管理部门应当对其批准的药品广告进行检查，对于违反本法和《中华人民共和国广告法》的广告，应当向广告监督管理机关通报并提出处理建议，广告监督管理机关应当依法作出处理。
Article 62 The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall inspect on the pharmaceutical advertisements they approve, and shall notify and advise the administrative departments of advertising if the advertisements is not in conformity with this Law and the Advertisement Law of the PRC. The administrative departments of advertising shall deal with such advertisements according to relevant regulations.
第六十三条 药品价格和广告，本法未规定的，适用《中华人民共和国价格法》、《中华人民共和国广告法》的规定。
Article 63 In the absence of regulations as provided in this Law, the Price Law of the PRC and the Advertisement Law of the PRC shall be applied to the control of pharmaceutical prices and advertisements.
第八章 药品监督
Chapter VIII Supervision over Pharmaceuticals
第六十四条 药品监督管理部门有权按照法律、行政法规的规定对报经其审批的药品研制和药品的生产、经营以及医疗机构使用药品的事项进行监督检查，有关单位和个人不得拒绝和隐瞒。
Article 64 Pharmaceutical supervisory and administrative departments are authorized to conduct, in accordance with laws and administrative regulations, supervision and inspection over the research,development, production and trade of pharmaceuticals which they have approved, as well as the medical organizations' use of pharmaceuticals. The units and individuals concerned shall not refuse to comply.
药品监督管理部门进行监督检查时，必须出示证明文件，对监督检查中知悉的被检查人的技术秘密和业务秘密应当保密。
Pharmaceutical supervisory and administrative departments shall present certificate documents while conducting supervision and inspection, and shall not divulge technological and business.
第六十五条 药品监督管理部门根据监督检查的需要，可以对药品质量进行抽查检验。抽查检验应当按照规定抽样，并不得收取任何费用。所需费用按照国务院规定列支。
Article 65 According to the needs of supervision and inspection, pharmaceutical supervisory and administrative departments may conduct sampling examinations on the quality of pharmaceuticals. The sampling examinations shall be conducted according to relevant regulations and shall not be charged a fee. The expenses incurred shall be dispensed with in conformity with the regulations prescribed by the State Council.
药品监督管理部门对有证据证明可能危害人体健康的药品及其有关材料可以采取查封、扣押的行政强制措施，并在七日内作出行政处理决定；药品需要检验的，必须自检验报告书发出之日起十五日内作出行政处理决定。
Pharmaceutical supervisory and administrative departments may take administrative coercive measures including sequestration and banning against pharmaceuticals and other relevant materials which have been proven to be of possible harm to people's health; administrative measures must be taken within seven days. For pharmaceuticals which need to be inspected, decisions regarding administrative handling must be made within 15 days from the date of issue of the inspection reports.
第六十六条 国务院和省、自治区、直辖市人民政府的药品监督管理部门应当定期公告药品质量抽查检验的结果；公告不当的，必须在原公告范围内予以更正。
Article 66 The pharmaceutical supervisory and administrative departments under the State Council and of the provinces, autonomous regions and municipalities directly under the central government shall regularly promulgate the results of sampling examinations and inspections on the quality of pharmaceuticals, and shall, in the case of improperly published statements, amend such statements in the original published documents.
第六十七条 当事人对药品检验机构的检验结果有异议的，可以自收到药品检验结果之日起七日内向原药品检验机构或者上一级药品监督管理部门设置或者确定的药品检验机构申请复验，也可以直接向国务院药品监督管理部门设置或者确定的药品检验机构申请复验。受理复验的药品检验机构必须在国务院药品监督管理部门规定的时间内作出复验结论。
Article 67 If a party concerned disagrees with the inspection decision made by the inspection institutions, it may apply for re-inspection to the original inspection institutions or ones established or appointed by the pharmaceutical supervisory and administrative departments of superior levels within seven days from the date of receiving the pharmaceutical inspection decision, and may directly apply for re-inspection to the inspection institutions established or appointed by the pharmaceutical supervisory and administrative department under the State Council. The inspection institutions which have accepted the re-inspections shall conclude the re-inspections within the time limit prescribed by the pharmaceutical supervisory and administrative department under the State Council.
第六十八条 药品监督管理部门应当按照规定，依据《药品生产质量管理规范》、《药品经营质量管理规范》，对经其认证合格的药品生产企业、药品经营企业进行认证后的跟踪检查。
rticle 68 Pharmaceutical supervisory and administrative departments shall follow up on the inspections of the pharmaceutical producing enterprises or pharmaceutical trading enterprises which they have certified in conformity with the "Quality Control Standard of Pharmaceutical Production" and the "Quality Control Standard of Pharmaceutical Trade."
第六十九条 地方人民政府和药品监督管理部门不得以要求实施药品检验、审批等手段限制或者排斥非本地区药品生产企业依照本法规定生产的药品进入本地区。
Article 69 The local people's governments and pharmaceutical supervisory and administrative departments shall not restrict or exclude the entrance of pharmaceuticals produced according to this Law by pharmaceutical producing enterprises in other regions of the country through the excuse of conducting inspection , examination and approval of the pharmaceuticals.
第七十条 药品监督管理部门及其设置的药品检验机构和确定的专业从事药品检验的机构不得参与药品生产经营活动，不得以其名义推荐或者监制、监销药品。
Article 70 Pharmaceutical supervisory and administrative departments and the pharmaceutical inspection institutions they have established, as well as the institutions exclusively engaged in pharmaceutical inspection they have appointed, shall not participate in pharmaceutical production and trade, and shall not endorse or supervise the production and sale of pharmaceuticals in their own names.
药品监督管理部门及其设置的药品检验机构和确定的专业从事药品检验的机构的工作人员不得参与药品生产经营活动。
The functionaries of pharmaceutical supervisory and administrative departments, of the pharmaceutical inspection institutions they established, and of the institutions exclusively engaged in the inspection of pharmaceuticals they appointed, shall not participate in pharmaceutical production and trade.
第七十一条 国家实行药品不良反应报告制度。药品生产企业、药品经营企业和医疗机构必须经�？疾毂镜ノ凰�、经营、使用的药品质量、疗效和反应。
Article 71 A reporting system over any adverse reactions of pharmaceuticals shall be practiced by Sstate. Pharmaceutical producing enterprises, pharmaceutical trading enterprises, and medical institutions shall conduct regular surveys on the quality, curative effects and adverse reactions of the pharmaceuticals they have produced, traded or used.
发现可能与用药有关的严重不良反应，必须及时向当地省、自治区、直辖市人民政府药品监督管理部门和卫生行政部门报告。具体办法由国务院药品监督管理部门会同国务院卫生行政部门制定。
When serious adverse reactions possibly related to the use of the pharmaceuticals are discovered, they must be promptly reported to the pharmaceutical supervisory and administrative departments and the administrative departments of health of the provinces, autonomous regions and municipalities directly under the central government. Detailed measures shall be formulated jointly by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of health under the State Council.
对已确认发生严重不良反应的药品，国务院或者省、自治区、直辖市人民政府的药品监督管理部门可以采取停止生产、销售、使用的紧急控制措施，并应当在五日内组织鉴定，自鉴定结论作出之日起十五日内依法作出行政处理决定。
Regarding the pharmaceuticals which have been confirmed to cause serious adverse reactions, the pharmaceutical supervisory and administrative department under the State Council and of the provinces, autonomous regions and municipalities directly under the central government, shall take urgent control measures including the cessation of the production, sale, and use of the pharmaceuticals, shall organize appraisals within five days, and shall make decisions on their administrative handling within 15 days from the conclusion date of the appraisals.
第七十二条 药品生产企业、药品经营企业和医疗机构的药品检验机构或者人员，应当接受当地药品监督管理部门设置的药品检验机构的业务指导。
Article 72 The organs or personnel in charge of pharmaceutical inspection in pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical organizations shall receive operational guidance from the pharmaceutical inspection institutions established by local pharmaceutical supervisory and administrative departments.
第九章 法律责任
CHAPTER IX Legal Responsibility
第七十三条 未取得《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》生产药品、经营药品的，依法予以取缔，没收违法生产、销售的药品和违法所得，并处违法生产、销售的药品（包括已售出的和未售出的药品，下同）货值金额二倍以上五倍以下的�？睿还钩煞缸锏�，依法追究刑事责任。
Article 73 Those who produce or trade in medicines without obtaining a Pharmaceutical Production License, Pharmaceutical Trade License, or Dispensing Permit of Medical Organizations, shall be placed under ban, have the unlawfully produced and sold medicines and any unlawful income confiscated, and may concurrently be fined a sum of money more than two but less than five times the value of the medicines unlawfully made or sold (including both sold and unsold pharmaceuticals, which also applies below). Those whose acts constitute a crime shall be investigated for criminal liabilities.
第七十四条 生产、销售假药的，没收违法生产、销售的药品和违法所得，并处违法生产、销售药品货值金额二倍以上五倍以下的�？�；有药品批准证明文件的予以撤销，并责令停产、停业整顿；情节严重的，吊销《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》；构成犯罪的，依法追究刑事责任。
Article 74 Those who produce and sell fake medicines shall have his unlawfully produced or sold medicines and any unlawful income confiscated, and concurrently be fined a sum of money more than two but less than five times the value value of the medicines unlawfully produced and sold. Those who have an approval certificate of pharmaceuticals shall have the certificate revokeded, and be ordered to suspend production or business operations pending rectification; if the circumstances are serious, the party shall have Pharmaceutical Production License, or Pharmaceutical Trade License or Dispensing Permit of Medical Organizations revoked. Those whose acts constitute a
第七十五条 生产、销售劣药的，没收违法生产、销售的药品和违法所得，并处违法生产、销售药品货值金额一倍以上三倍以下的�？�；情节严重的，责令停产、停业整顿或者撤销药品批准证明文件、吊销《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》；构成犯罪的，依法追究刑事责任。
Article 75 Those who produce and sell medicines of inferior quality shall have his unlawfully made and sold medicines and any unlawful income confiscated, and be concurrently fined the sum of money more than two but less than three times the value of the medicines unlawfully made or sold; if the circumstances are serious, the party shall be ordered to suspend production or business pending rectification, or have thepharmaceutical approval certificate revoked and his Pharmaceutical Production License, or Pharmaceutical Trade License or Dispensing Permit of Medical Organizations revoked. Those whose acts constitute a crime will be investigated for criminal liabilities.
第七十六条 从事生产、销售假药及生产、销售劣药情节严重的企业或者其他单位，其直接负责的主管人员和其他直接责任人员十年内不得从事药品生产、经营活动。
Article 76 The person-in-charge or personnel directly liable in the enterprise or other unit which produces and sells fake medicines or produces and sells pharmaceuticals of inferior quality shall not be permitted to engage in the production and trade of pharmaceuticals for ten years, if the circumstances are serious.
对生产者专门用于生产假药、劣药的原辅材料、包装材料、生产设备，予以没收。
The producers' supplementary materials, packaging materials and production equipment which are used exclusively for producing fake medicines and medicines of inferior quality shall be confiscated.
第七十七条 知道或者应当知道属于假劣药品而为其提供运输、保管、仓储等便利条件的，没收全部运输、保管、仓储的收入，并处违法收入百分之五十以上三倍以下的�？睿还钩煞缸锏�，依法追究刑事责任。
Article 77 Those who provide facilities including transportation, preservation and storage that have been or should have been aware of the fakery or inferior quality of the pharmaceuticals, shall have the entirety of his income from such transportation, preservation and storage confiscated, and concurrently be fined a sum of money more than 50% but less than three times the value of the unlawful income. Those whose acts constitute a crime shall be investigated for criminal liabilities.
第七十八条 对假药、劣药的处罚通知，必须载明药品检验机构的质量检验结果；但是，本法第四十八条第三款第（一）、（二）、（五）、（六）项和第四十九条第三款规定的情形除外。
Article 78 The notice of penalties on fake medicines and medicines of inferior quality shall indicate the inspection results of the inspection institution. However, this does not apply to the circumstances prescribed by Article 48(3)(a)(b)(e)(f) and Article 49 (3) of this Law.
第七十九条 药品的生产企业、经营企业、药物非临床安全性评价研究机构、药物临床试验机构未按照规定实施《药品生产质量管理规范》、《药品经营质量管理规范》、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的，给予警告，责令限期改正；逾期不改正的，责令停产、停业整顿，并处五千元以上二万元以下的罚款；情节严重的，吊销《药品生产许可证》、《药品经营许可证》和药物临床试验机构的资格。
Article 79 Pharmaceutical producing enterprises, trading enterprises, pharmaceutical non-clinical safety appraisal research institution, and pharmaceutical clinical testing institutions, shall be served a warning and be ordered to amend themselves within a prescribed time limit if they do not carry out the stipulations of the "Quality Control Standard of Pharmaceutical Production," the "Quality Control Standard of Pharmaceutical Trade," the quality control standard of pharmaceutical non-clinical research, and the quality control standard of pharmaceutical clinical testing. Those who do not rectify their mistakes within the prescribed time limit shall be ordered to suspend production and business operations pending rectification, and be concurrently fined more than 5000 but less than 20,000 RMB. If the circumstances are serious, they shall have their Pharmaceutical Production License, Pharmaceutical Trading License or Dispensing Permit of Medical Organizations revoked.
第八十条 药品的生产企业、经营企业或者医疗机构违反本法第三十四条的规定，从无《药品生产许可证》、《药品经营许可证》的企业购进药品的，责令改正，没收违法购进的药品，并处违法购进药品货值金额二倍以上五倍以下的�？�；有违法所得的，没收违法所得；情节严重的，吊销《药品生产许可证、《药品经营许可证》或者医疗机构执业许可证书。
Article 80 If any pharmaceutical producing enterprises, pharmaceutical trading enterprises or medical organizations violate Article 34 of this Law and purchase medicines from enterprises without the Pharmaceutical Production License or Pharmaceutical Trade License, they shall be ordered to amend themselves, have their unlawfully purchased medicines confiscated, and be concurrently fined the sum of money more than two but less than five times the value of the unlawfully purchased medicines. If they have obtained any unlawful income, the unlawful income shall be confiscated; if the circumstances are serious, their Pharmaceutical Production License, Pharmaceutical Trading License or Practicing Permit of Medical Organizations shall be revoked.
第八十一条 进口已获得药品进口注册证书的药品，未按照本法规定向允许药品进口的口岸所在地的药品监督管理部门登记备案的，给予警告，责令限期改正；逾期不改正的，撤销进口药品注册证书。
Article 81 Those who import pharmaceuticals with a pharmaceutical import registration document and fail to register according to this Law at the pharmaceutical supervisory and administrative department at the location of the port allowed for pharmaceutical import, shall be served a warning and be ordered to correct its mistakes within a prescribed time limit. Those who have not corrected its mistakes within the prescribed time limit shall have their registration document to import pharmaceuticals revoked.
第八十二条 伪造、变造、买卖、出租、出借许可证或者药品批准证明文件的，没收违法所得，并处违法所得一倍以上三倍以下的�？�；没有违法所得的，处二万元以上十万元以下的�？�；情节严重的，并吊销卖方、出租方、出借方的《药品生产许可证》、《药品经营许可证》、《医疗机构制剂许可证》或者撤销药品批准证明文件；构成犯罪的，依法追究刑事责任。
Article 82 Those who forge, alter, trade, lease or lend licenses or pharmaceutical approval certificates, shall have their unlawful income confiscated and be concurrently fined the sum of money more than two but less than three times the amount of the unlawful income. If the party has not obtained unlawful income yet, it will be fined more than 20,000 but less than 100,000 RMB; if the circumstances are serious, the Pharmaceutical Production License, Pharmaceutical trading License or Dispensing Permit of Medical Organizations of the seller, lessor or lender shall be revoked, or the pharmaceutical approval certificate shall be recalled. Those whose acts constitute a crime shall be investigated for criminal liabilities.
第八十三条 违反本法规定，提供虚假的证明、文件资料样品或者采取其他欺骗手段取得《药品生产许可证》、《药品经营许可证》、《医疗机构制剂许可证》或者药品批准证明文件的，吊销《药品生产许可证》、《药品经营许可证》、《医疗机构制剂许可证》或者撤销药品批准证明文件，五年内不受理其申请，并处一万元以上三万元以下的�？睢�
Article 83 Those who violate this Law by providing false certificates or samples of documents, or obtaining the Pharmaceutical Production License, the Pharmaceutical Trading License, the Dispensing Permit of Medical Organizations or pharmaceutical approval certificates through cheating, shall have their Pharmaceutical Production License, Pharmaceutical Trade License, or Dispensing Permit of Medical Organizations revoked, have their pharmaceutical approval certificates revoked, have their application rejected for five years, and have a concurrent fine of more than 10,000 but less than 30,000 RMB be imposed upon them.
第八十四条 医疗机构将其配制的制剂在市场销售的，责令改正，没收违法销售的制剂，并处违法销售制剂货值金额一倍以上三倍以下的�？睿挥形シㄋ玫�，没收违法所得。
Article 84 If a medical organization sells its preparations on the market, it shall be ordered to correct its mistakes, have its unlawfully sold preparations confiscated and concurrently be fined a sum of money more than two but less than three times the value of the unlawfully sold preparations. If it has obtained any unlawful income, the unlawful income shall be confiscated.
第八十五条 药品经营企业违反本法第十八条、第十九条规定的，责令改正，给予警告；情节严重的，吊销《药品经营许可证》。
Article 85 If a pharmaceutical trading enterprise violates Article 18 and Article 19 of this law, it shall be ordered to amend itself and be served a warning. If the circumstances are serious, its Pharmaceutical Trading License shall be revoked.
第八十六条 药品标识不符合本法第五十四条规定的，除依法应当按照假药、劣药论处的外，责令改正，给予警告；情节严重的，撤销该药品的批准证明文件。
Article 86 A medicine whose mark is not in conformity with Article 54 of this Law shall be handled as fake medicine or medicine of inferior quality. In addition, a correction shall be made and a warning shall be served. If the circumstances are serious, the approval certificate of this medicine shall be revoked.
第八十七条 药品检验机构出具虚假检验报告，构成犯罪的，依法追究刑事责任；不构成犯罪的，责令改正，给予警告，对单位并处三万元以上五万元以下的�？�；对直接负责的主管人员和其他直接责任人员依法给予降级、撤职、开除的处分，并处三万元以下的�？�；
Article 87 A pharmaceutical inspection institution which produces false inspection reports, where the circumstances are so serious as to constitute a crime, shall be investigated for criminal liabilities; if a crime is not constituted, it shall be ordered to amend and be served a warning. The institution shall be concurrently imposed a fine of more than 30,000 but less than 50,000 RMB, and the person-in-charge and other personnel directly liable shall be demoted, dismissed from their posts, or expelled according to law, and shall be concurrently be fined less than 30,000RMB.
有违法所得的，没收违法所得；情节严重的，撤销其检验资格。药品检验机构出具的检验结果不实，造成损失的，应当承担相应的赔偿责任。
If any unlawful income has been obtained, the unlawful income shall be confiscated. If the circumstances are serious, the inspection qualification certificate shall be revoked. If an inspection institution produces false inspection reports and causes serious consequences, it shall bear corresponding liabilities for compensation.
第八十八条 本法第七十三条至第八十七条规定的行政处罚，由县级以上药品监督管理部门按照国务院药品监督管理部门规定的职责分工决定；吊销《药品生产许可证》、《药品经营许可证、《医疗机构制剂许可证》、医疗机构执业许可证书或者撤销药品批准证明文件的，由原发证、批准的部门决定。
Article 88 The decision to impose administrative sanctions stipulated from Article 73 to Article 87 by this Law shall be made by the pharmaceutical supervisory and administrative departments at or above the county level in conformity with the division of functions prescribed by the pharmaceutical supervisory and administrative department under the State Council. The original issue and approval departments shall decide regarding the revocation of the Pharmaceutical Production License, the Pharmaceutical Trading License, the Dispensing Permit of Medical Organizations, the practicing permit of medical organizations, and the pharmaceutical approval certificates.
第八十九条 违反本法第五十五条、第五十六条、第五十七条关于药品价格管理的规定的，依照《中华人民共和国价格法》的规定处罚。
Article 89 Violations of Article 55, 56, 57 of this Law concerning the price control of pharmaceuticals shall be punished according to the Price Law of the People's Republic of China.
第九十条 药品的生产企业、经营企业、医疗机构在药品购销中暗中给予、收受回扣或者其他利益的，药品的生产企业、经营企业或者其代理人给予使用其药品的医疗机构的负责人、药品采购人员、医师等有关人员以财物或者其他利益的，由工商行政管理部门处一万元以上二十万元以下的罚款，有违法所得的，予以没收；
Article 90 If pharmaceutical producing enterprises, trading enterprises and medical organizations give or receive commissions or other interests in secret during the purchase or sale of pharmaceuticals; and if pharmaceutical producing enterprises, trading enterprises or their agents give any property or other interests to the directors, buyers, physicians and other relevant persons in the medical organizations where their medicines are used, a fine of more than 10,000 but less than 200,000 RMB shall be imposed and the unlawful income shall be confiscated by the government body of industry and commerce administration
情节严重的，由工商行政管理部门吊销药品生产企业、药品经营企业的营业执照，并通知药品监督管理部门，由药品监督管理部门吊销其《药品生产许可证》、《药品经营许可证》；构成犯罪的，依法追究刑事责任。
who, if the circumstances are serious, shall revoke the business licenses of the pharmaceutical producing enterprises and pharmaceutical trading enterprises, and shall notify the pharmaceutical supervisory and administrative departments which shall revoke the Pharmaceutical Production License and Pharmaceutical Trading License. If a crime is constituted, an investigation shall be made for criminal liabilities.
第九十一条 药品的生产企业、经营企业的负责人、采购人员等有关人员在药品购销中收受其他生产企业、经营企业或者其代理人给予的财物或者其他利益的，依法给予处分，没收违法所得；构成犯罪的，依法追究刑事责任。
Article 91 If directors or buyers of pharmaceutical producing enterprises or trading enterprises receive any property or other interests from other producing enterprises, trading enterprises or their agents during the purchase or sale of medicines, they shall be punished according to relevant regulations and shall have their unlawful income confiscated. If a crime is constituted, an investigation shall be made for criminal liabilities.
医疗机构的负责人、药品采购人员、医师等有关人员收受药品生产企业、药品经营企业或者其代理人给予的财物或者其他利益的，由卫生行政部门或者本单位给予处分，没收违法所得；对违法行为情节严重的执业医师，由卫生行政部门吊销其执业证书；构成犯罪的，依法追究刑事责任。
If the directors, buyers, physicians or other relevant persons in medical organizations receive any property or other interests from pharmaceutical producing enterprises, pharmaceutical trading enterprises or their agents, they shall be punished by the administrative departments of health or the work units where they work, and have their unlawful income confiscated. If practicing physicians seriously violate the law, his practice certificate shall be revoked by the administrative departments of health. If a crime is constituted, an investigation shall be made for criminal liabilities in conformity with relevant laws and regulations.
第九十二条 违反本法有关药品广告的管理规定的，依照《中华人民共和国广告法》的规定处罚，并由发给广告批准文号的药品监督管理部门撤销广告批准文号，一年内不受理该品种的广告审批申请；构成犯罪的，依法追究刑事责任。
Article 92 Those who act against the administrative regulations concerning pharmaceutical advertisement as provided in this Law shall be sanctioned in conformity with the Advertisement Law of the PRC, have its advertisement registration number revoked by the pharmaceutical supervisory and administrative departments from which the registration number has been issued, and its application for the approval of the advertisement regarding this variety of medicines shall not be accepted for one year. If a crime is constituted, an investigation of criminal liabilities shall be made in conformity with relevant laws and regulations.
药品监督管理部门对药品广告不依法履行审查职责，批准发布的广告有虚假或者其他违反法律、行政法规的内容的，对直接负责的主管人员和其他直接责任人员依法给予行政处分；构成犯罪的，依法追究刑事责任。
If a pharmaceutical supervisory or administrative department does not perform its duty of inspection on pharmaceutical advertisements which results in the publishing of advertisements containing falsehoods or other content against laws and administrative regulations, the directly liable person in charge and other responsible personnel shall be subject to administrative sanction. If their acts constitute a crime, they shall be investigated for criminal liabilities in conformity with relevant regulations.
第九十三条 药品的生产企业、经营企业、医疗机构违反本法规定，给药品使用者造成损害的，依法承担赔偿责任。
Article 93 If pharmaceutical producing enterprises, trading enterprises or medical organizations act against this law which results in damages to the users of pharmaceut, icals, they shall bear liabilities of compensation in conformity with relevant regulations.
第九十四条 药品监督管理部门违反本法规定，有下列行为之一的，由其上级主管机关或者监察机关责令收回违法发给的证书、撤销药品批准证明文件，对直接负责的主管人员和其他直接责任人员依法给予行政处分；构成犯罪的，依法追究刑事责任：
Article 94 If a pharmaceutical supervisory and administrative department violates this law with one of the following acts, a competent authority of a higher level or a supervisory organization shall order it to withdraw the unlawfully issued certificates, revoke the pharmaceutical approval certificates, and render administrative sanctions against the directly liable person in charge and other responsible personnel. If their acts constitute a crime, they shall be investigated for criminal liabilities.
（一）对不符合《药品生产质量管理规范》、《药品经营质量管理规范》的企业发给符合有关规范的认证证书的，或者对取得认证证书的企业未按照规定履行跟踪检查的职责，对不符合认证条件的企业未依法责令其改正或者撤销其认证证书的；
(1) issue a certificate of qualification to an enterprise which does not meet the requirements of the "Quality Control Standard of Pharmaceutical Production" and the "Quality Control Standard of Pharmaceutical Trading," fail to conduct inspections according to relevant regulations on the enterprises which have already obtained certificates, or fail to order the unqualified enterprises to amend themselves or revoke their certificates according to relevant regulations; or
（二）对不符合法定条件的单位发给《药品生产许可证》、《药品经营许可证》或者《医疗机构制剂许可证》的；
(2) issue a Pharmaceutical Production License, a Pharmaceutical Trading License or a Dispensing Permit of Medical Organizations to a unit which does not meet legal requirements;
（三）对不符合进口条件的药品发给进口药品注册证书的；
(3) issue a registration certificate of import to a medicine which does not meet the requirements for import; or
（四）对不具备临床试验条件或者生产条件而批准进行临床试验、发给新药证书、发给药品批准文号的。
(4) approve a clinic test when the requirements for clinic tests are not met, or issue certificates of new medicines and pharmaceutical approval document numbers when requirements for production are not met.
第九十五条 药品监督管理部门或者其设置的药品检验机构或者其确定的专业从事药品检验的机构参与药品生产经营活动的，由其上级机关或者监察机关责令改正，有违法收入的予以没收；情节严重的，对直接负责的主管人员和其他直接责任人员依法给予行政处分。
Article 95 If a pharmaceutical supervisory and administrative department, or an inspection institution it has established, or an organization exclusively engaged in pharmaceutical inspection it has appointed, participates in the production and trade of pharmaceuticals, the responsible authority of a higher level or a supervisory organization shall order it to amend itself and have its unlawful income confiscated. If the circumstances are serious, the directly liable person in charge and other responsible personnel shall be subject to administrative sanctions.
药品监督管理部门或者其设置的药品检验机构或者其确定的专业从事药品检验的机构的工作人员参与药品生产经营活动的，依法给予行政处分。
If a staff member in a pharmaceutical supervisory and administrative department, or in an inspection institution it has established, or in an organization exclusively engaged in pharmaceutical inspection it has appointed, participates in the production and trade of pharmaceuticals, he or she shall be subject to administrative sanction.
第九十六条 药品监督管理部门或者其设置、确定的药品检验机构在药品监督检验中违法收取检验费用的，由政府有关部门责令退还，对直接负责的主管人员和其他直接责任人员依法给予行政处分。对违法收取检验费用情节严重的药品检验机构，撤销其检验资格。
Article 96 If a pharmaceutical supervisory and administrative department or a pharmaceutical inspection institution it has established or appointed unlawfully collects inspection fees during a pharmaceutical supervision and inspection, it shall be ordered by the government bodies concerned to make reimbursements, and the directly liable person and other responsible personnel shall be subject to administrative sanctions. If the circumstances are serious, the certificate of qualification of the inspection institution which has unlawfully collected inspection fees shall be revoked.
第九十七条 药品监督管理部门应当依法履行监督检查职责，监督已取得《药品生产许可证》、《药品经营许可证》的企业依照本法规定从事药品生产、经营活动。
Article 97 A pharmaceutical supervisory and administrative department shall perform its duty of supervision and inspection according to laws and regulations, and shall supervise the production and trade of the enterprises which have obtained a Pharmaceutical Production License or a Pharmaceutical Trade License according to the regulations of this Law.
已取得《药品生产许可证》、《药品经营许可证》的企业生产、销售假药、劣药的，除依法追究该企业的法律责任外，对有失职、渎职行为的药品监督管理部门直接负责的主管人员和其他直接责任人员依法给予行政处分；构成犯罪的，依法追究刑事责任。
If an enterprise which has obtained a Pharmaceutical Production License or a Pharmaceutical Trade License produces and sells fake medicines and medicines of inferior quality, the enterprise shall be investigated for legal liabilities according to laws and regulations. In addition, the directly liable person in charge and other responsible personnel in the pharmaceutical supervisory and administrative department who have neglected or have been derelict in their duty shall be subject to administrative sanction. If a crime is constituted, the party shall be investigated for criminal liabilities according to laws and regulations.
第九十八条 药品监督管理部门对下级药品监督管理部门违反本法的行政行为，责令限期改正；逾期不改正的，有权予以改变或者撤销。
Article 98 A pharmaceutical supervisory and administrative department shall, within a prescribed time limit, order a pharmaceutical supervisory and administrative department of a lower level to correct an administrative act which is not in conformity with this Law. If the administrative act is not corrected within the prescribed time limit, the department shall have the power to change or repeal it.
第九十九条 药品监督管理人员滥用职权、徇私舞弊、玩忽职守，构成犯罪的，依法追究刑事责任；尚不构成犯罪的，依法给予行政处分。
Article 99 If the personnel of the pharmaceutical supervision and administration misuse their authority, engage in irregular practices due to favoritism, or neglect their duties to such an extent that a crime is constituted, they shall be investigated for criminal liabilities. If their acts have not constituted a crime, they shall be subject to administrative sanctions.
第一百条 依照本法被吊销《药品生产许可证》、《药品经营许可证》的，由药品监督管理部门通知工商行政管理部门办理变更或者注销登记。
Article 100 If a Pharmaceutical Production License or a Pharmaceutical Trade License is revoked according to this Law, the pharmaceutical supervisory and administrative department shall notify the industry and commerce administrative department to alter or annul the registration.
第一百零一条 本章规定的货值金额以违法生产、销售药品的标价计算；没有标价的，按照同类药品的市场价格计算。
Article 101 The value of goods as prescribed in this chapter is designated according to the marked price of the unlawfully made or sold medicines. In the absence of a marked price, the value of goods shall be designated according to the market price of pharmaceuticals of the same kind.
第十章 附则
Chapter X Supplementary Provisions
第一百零二条 本法下列用语的含义是：
Article 102 For the purpose of this Law, the following definitions are offered:
药品，是指用于预防、治疗、诊断人的疾病，有目的地调节人的生理机能并规定有适应症或者功能主治、用法和用量的物质，包括中药材、中药饮片、中成药、化学原料药及其制剂、抗生素、生化药品、放射性药品、血清、疫苗、血液制品和诊断药品等。
" Pharmaceuticals " means the articles intended for use in the prevention, treatment or diagnosis of human diseases, or intended to effect the purposive regulation of human physiological functions, for which indications or major functions, usage and dosage are prescribed. They include raw traditional Chinese medicinal materials, traditional medicines prepared in ready-to-use forms, and other prepared Chinese medicines, medicinal chemicals and their preparations, antibiotics, biochemical medicines, radioactive drugs, serums, vaccines, blood products, diagnostic aids, etc.
辅料，是指生产药品和调配处方时所用的赋形剂和附加剂。
" Supplementary materials " means the excipients and additives used for the production and dispensing of pharmaceuticals.
药品生产企业，是指生产药品的专营企业或者兼营企业。
" Pharmaceutical producing enterprise " means an enterprise exclusively or partly engaged in the production of pharmaceuticals.
药品经营企业，是指经营药品的专营企业或者兼营企业。
" Pharmaceutical trading enterprise " means an enterprise exclusively or partly engaged in the trade of pharmaceuticals.
第一百零三条 中药材的种植、采集和饲养的管理办法，由国务院另行制定。
Article 103 Measures for the control of cultivation, collection and breeding of all categories of medicinal materials used in traditional Chinese medicine shall be seperately formulated by the State Council .
第一百零四条 国家对预防性生物制品的流通实行特殊管理。具体办法由国务院制定。
Article 104 The State Council shall formulate detailed measures to carry out special control on the circulation of preventive bioproducts.
第一百零五条 中国人民解放军执行本法的具体办法，由国务院、中央军事委员会依据本法制定。
Article 105 Detailed measures for the implementation of this law by the Chinese People's Army shall be formulated by the State Council and the Central Military Committee of the State on the basis of this Law.
第一百零六条 本法自２００１年１２月１日起施行。
Article 106 This Law shall enter into force as of December 1, 2001.
