| Regulations for the Implementation of the Drug Administration Law of the People's Republic of China | | 中华人民共和国药品管理法实施条例 |
| (Promulgated by the Order No. 360 of the State Council of the People's Republic of China on August 4, 2002; and revised in accordance with the Decision of the State Council on Amending Some Administrative Regulations on February 6, 2016) | | （2002年8月4日中华人民共和国国务院令第360号公布 根据2016年2月6日《国务院关于修改部分行政法规的决定》修订） |
| Chapter 1 General Provisions | | 第一章 总 则 |
| Article 1 The Regulations are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law). | | |
| Article 2 The drug regulatory department under the State Council shall establish a national drug testing institute. | | 第一条 根据《中华人民共和国药品管理法》（以下简称《药品管理法》），制定本条例。 |
| The drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government may establish drug testing institutes within its respective administrative area. The plan for the establishment of local drug testing institutes shall be proposed by the drug regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government and submitted to the people's government of the province, autonomous region and municipality directly under the Central Government for approval. | | |
| The drug regulatory department under the State Council and the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government may, when necessary, designate any testing institute fulfilling the requirements for drug testing to undertake drug testing. | | 第二条 国务院药品监督管理部门设置国家药品检验机构。 |
| Chapter II Control over Drug Manufacturers | | 省、自治区、直辖市人民政府药品监督管理部门可以在本行政区域内设置药品检验机构。地方药品检验机构的设置规划由省、自治区、直辖市人民政府药品监督管理部门提出，报省、自治区、直辖市人民政府批准。 |
| Article 3 To form a pharmaceutical manufacturing enterprise, the applicant shall file the application with the drug administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the manufacturing enterprise is to be located. The drug administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall, within 30 working days of receipt of the application, organize inspection according to the conditions for formation prescribed in Article 8 of the Pharmaceutical Administration Law; and if the inspection is passed, a Pharmaceutical Production Permit shall be issued. | | 国务院和省、自治区、直辖市人民政府的药品监督管理部门可以根据需要，确定符合药品检验条件的检验机构承担药品检验工作。 |
| Article 4 Any drug manufacturer that intends to alter the approved items in the Drug Manufacturing Certificate shall, 30 days prior to alteration of any approved items, apply to the original certificate-issuing authority for registration of alteration; no approved items may be altered without approval. The original certificate-issuing authority shall make a decision within 15 working days from the date it receives the application. | | 第二章 药品生产企业管理 |
| Article 5 The drug regulatory department of the people's government at or above the provincial level shall organize inspections of drug manufacturers in accordance with the Good Manufacturing Practice for Pharmaceutical Products (GMP) and the measures and schedule for implementing the GMP formulated by the drug regulatory department under the State Council, and issue a certificate to the manufacturer that complies with the GMP. For the manufacturer producing injections or radioactive pharmaceuticals and for that producing biological products specified by the drug regulatory department under the State Council, the inspection of which shall be conducted by the drug regulatory department under the State Council. | | |
| The format of GMP certificate shall be uniformly provided for by the drug regulatory department under the State Council. | | 第三条 开办药品生产企业，申办人应当向拟办企业所在地省、自治区、直辖市人民政府药品监督管理部门提出申请。省、自治区、直辖市人民政府药品监督管理部门应当自收到申请之日起30个工作日内，依据《药品管理法》第八条规定的开办条件组织验收；验收合格的，发给《药品生产许可证》。 |
| Article 6 Any newly-established drug manufacturer or manufacturer with newly-built drug manufacturing workshops or newly-added dosage forms for production shall, within 30 days from the date it obtains the approval documents for manufacturing drug or from the date its formal production is approved, apply to the drug regulatory department for GMP certification as required. The drug regulatory department accepting the application shall, within six months from the date it receives the application, organize inspections as to the compliance with the GMP requirements by the applying manufacturer. A certificate shall be issued to the manufacturer if the inspection is passed. | | |
| Article 7 The drug regulatory department under the State Council shall set up a database of GMP inspectors. A GMP inspector shall be qualified as required by the drug regulatory department under the State Council. A GMP inspection shall be conducted by a team of inspectors randomly selected from the database of GMP inspectors according to the provisions of the drug regulatory department under the State Council. | | 第四条 药品生产企业变更《药品生产许可证》许可事项的，应当在许可事项发生变更30日前，向原发证机关申请《药品生产许可证》变更登记；未经批准，不得变更许可事项。原发证机关应当自收到申请之日起15个工作日内作出决定。 |
| Article 8 The valid term of a Drug Manufacturing Certificate is five years. To continue its drug production, the Certificate holder shall, six months prior to the expiry date of the Certificate, apply for the renewal of the Drug Manufacturing Certificate according to the provisions of the drug regulatory department under the State Council. | | |
| Where a drug manufacturer terminates its drug production or is closed down, its Drug Manufacturing Certificate shall be withdrawn by the original certificate-issuing authority. | | 第五条 省级以上人民政府药品监督管理部门应当按照《药品生产质量管理规范》和国务院药品监督管理部门规定的实施办法和实施步骤，组织对药品生产企业的认证工作；符合《药品生产质量管理规范》的，发给认证证书。其中，生产注射剂、放射性药品和国务院药品监督管理部门规定的生物制品的药品生产企业的认证工作，由国务院药品监督管理部门负责。 |
| Article 9 Any drug substance used by a drug manufacturer to produce drug products shall have a drug approval number or an import drug license or a pharmaceutical product license issued by the drug regulatory department under the State Council upon examination, with the exception of Chinese crude drugs and the prepared slices of Chinese crude drugs over which no control by approval number is exercised. | | 《药品生产质量管理规范》认证证书的格式由国务院药品监督管理部门统一规定。 |
| Article 10 In accordance with the provisions in Article 13 of the Drug Administration Law, any drug manufacturer being entrusted with contract production of the drug shall have a GMP certificate corresponding to the contracted drug. | | |
| No vaccines, blood products or other drugs specified by the drug regulatory department under the State Council may be contracted for production. | | 第六条 新开办药品生产企业、药品生产企业新建药品生产车间或者新增生产剂型的，应当自取得药品生产证明文件或者经批准正式生产之日起30日内，按照规定向药品监督管理部门申请《药品生产质量管理规范》认证。受理申请的药品监督管理部门应当自收到企业申请之日起6个月内，组织对申请企业是否符合《药品生产质量管理规范》进行认证；认证合格的，发给认证证书。 |
| Chapter III Control over Drug Distributors | | |
| Article 11 For establishment of a drug wholesaler, the applicant shall submit an application to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, where the planned drug wholesaler is to be located. The drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days from the date it receives the application, make a decision on approval or disapproval according to the standards for establishment set forth by the drug regulatory department under the State Council. After completion of establishment of the planned wholesaler, the applicant shall apply to the original approving department for acceptance inspection. The original approving department shall, within 30 working days from the date it receives the application, organize an acceptance inspection according to the requirements for establishment of drug distributors set forth in Article 15 of the Drug Administration Law and issue the Drug Supply Certificate to the applicant if the inspection is passed. | | 第七条 国务院药品监督管理部门应当设立《药品生产质量管理规范》认证检查员库。《药品生产质量管理规范》认证检查员必须符合国务院药品监督管理部门规定的条件。进行《药品生产质量管理规范》认证，必须按照国务院药品监督管理部门的规定，从《药品生产质量管理规范》认证检查员库中随机抽取认证检查员组成认证检查组进行认证检查。 |
| Article 12 For establishment of a drug retailer, the applicant shall submit an application to the drug regulatory institution of the municipality divided into districts, or to the drug regulatory institution at the county level which is directly set up by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, where the planned retailer is to be located. The drug regulatory institution accepting the application shall, within 30 working days from the date it receives the application, make a decision on approval or disapproval after the review according to the provisions of the drug regulatory department under the State Council, taking into consideration the number of permanent residents, territory, transportation and practical needs in the place. After completion of establishment of the planned retailer, the applicant shall apply to the original approving department for acceptance inspections. The original approving department shall, within 15 working days from the date it receives the application, organize acceptance inspections according to the requirements for establishment of drug distributors set forth in Article 15 of the Drug Administration Law and issue a Drug Supply Certificate if inspections are passed. | | |
| Article 13 The drug administrative departments of the people's governments of provinces, autonomous regions, or municipalities directly under the Central Government and the drug administrative agencies at the level of a districted city shall be responsible for organizing the certification of pharmaceutical trading enterprises. A pharmaceutical trading enterprise shall, according to the implementation measures and the implementation steps prescribed by the drug administrative department of the State Council, pass the certification of compliance with the Good Distribution Practices for Pharmaceutical Products (“GDP”) organized by the drug administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government or the drug administrative agency at the level of a districted city, and obtain a GDP certificate. The format of a GDP certificate shall be uniformly prescribed by the drug administrative department of the State Council. | | 第八条 《药品生产许可证》有效期为5年。有效期届满，需要继续生产药品的，持证企业应当在许可证有效期届满前6个月，按照国务院药品监督管理部门的规定申请换发《药品生产许可证》。 |
| A newly-formed pharmaceutical wholesaler or retailer shall, within 30 days of obtaining the Pharmaceutical Distribution Permit, apply for the HYPERLINK "javascript:ESLC(250539,0)" GDP certification to the drug administrative department or agency which issued the Pharmaceutical Distribution Permit to it. The drug administrative department or agency accepting the application shall, within three months of receipt of the application, organize the certification of GDP compliance of the pharmaceutical wholesaler or retailer applying for certification in accordance with the provisions issued by the drug administrative department of the State Council, and issue a HYPERLINK "javascript:ESLC(250539,0)" GDP certificate to the pharmaceutical wholesaler or retailer if it passes the certification. | | 药品生产企业终止生产药品或者关闭的，《药品生产许可证》由原发证部门缴销。 |
| Article 14 A database of GSP inspectors shall be set up by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government. A GSP inspector shall be qualified as required by the drug regulatory department under the State Council. A GSP inspection shall be conducted by a team of inspectors randomly selected from the said database according to the provisions of the drug regulatory department under the State Council. | | |
| Article 15 The State adopts a classification system for prescription drugs and non-prescription drugs. The State subdivides non-prescription drugs into Class A drugs and Class B drugs according to the level of safety. | | 第九条 药品生产企业生产药品所使用的原料药，必须具有国务院药品监督管理部门核发的药品批准文号或者进口药品注册证书、医药产品注册证书；但是，未实施批准文号管理的中药材、中药饮片除外。 |
| Any drug retailer distributing prescription drugs or Class A non-prescription drugs shall have licensed pharmacists or other pharmaceutical technicians whose qualifications are legally recognized. Any retailer distributing Class B non-prescription drugs shall have pharmacy staff members who have passed the examination organized by the local drug regulatory institution of the municipality divided into districts or by the local drug regulatory institution at the county level which is directly set up by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government. | | |
| Article 16 Any drug distributor that intends to alter the approved items in the Drug Supply Certificate shall, 30 days prior to the alteration of any approved items, apply to the original certificate-issuing authority for registration of alteration; no approved items may be altered without approval. The original certificate-issuing authority shall make a decision within 15 working days from the date it receives the application. | | 第十条 依据《药品管理法》第十三条规定，接受委托生产药品的，受托方必须是持有与其受托生产的药品相适应的《药品生产质量管理规范》认证证书的药品生产企业。 |
| Article 17 The valid term of a Drug Supply Certificate is five years. To continue its drug distribution, the Certificate holder shall, six months prior to the expiry date of the Certificate, apply for the renewal of the Drug Supply Certificate according to the provisions of the drug regulatory department under the State Council. | | 疫苗、血液制品和国务院药品监督管理部门规定的其他药品，不得委托生产。 |
| Where a drug distributor terminates its drug distribution or is closed down, its Drug Supply Certificate shall be withdrawn by the original certificate-issuing authority. | | 第三章 药品经营企业管理 |
| Article 18 Where there is no drug retailers at town or country fairs in remote areas with poor communications, the local drug retailers may, after obtaining approval from the local drug regulatory institution of the county (municipality) and being registered with the administrative department for industry and commerce, set up stores at the fairs to sell non-prescription drugs within the approved scope for drug distribution. | | |
| Article 19 Drug manufactures, drug distributors and medical institutions engaged in on-line drug transactions through Internet and the drugs so transacted shall be in conformity with the provisions in the Drug Administration Law and in the Regulations. The measures for administration of on-line drug distribution services shall be formulated by the drug regulatory department under the State Council jointly with the other relevant departments under the State Council. | | 第十一条 开办药品批发企业，申办人应当向拟办企业所在地省、自治区、直辖市人民政府药品监督管理部门提出申请。省、自治区、直辖市人民政府药品监督管理部门应当自收到申请之日起30个工作日内，依据国务院药品监督管理部门规定的设置标准作出是否同意筹建的决定。申办人完成拟办企业筹建后，应当向原审批部门申请验收。原审批部门应当自收到申请之日起30个工作日内，依据《药品管理法》第十五条规定的开办条件组织验收；符合条件的，发给《药品经营许可证》。 |
| Chapter IV Control over Pharmaceuticals in Medical Institutions | | |
| Article 20 To establish a pharmaceutical preparation unit in a medical institution, an application shall be submitted to the local health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government, and, after being consented upon examination, be presented to the drug regulatory department of the people's government at the same level for review and approval. Approval shall be given to the medical institution if it passes the review by the said drug regulatory department and a Pharmaceutical Preparation Certificate for Medical Institution shall be issued to it. | | 第十二条 开办药品零售企业，申办人应当向拟办企业所在地设区的市级药品监督管理机构或者省、自治区、直辖市人民政府药品监督管理部门直接设置的县级药品监督管理机构提出申请。受理申请的药品监督管理机构应当自收到申请之日起30个工作日内，依据国务院药品监督管理部门的规定，结合当地常住人口数量、地域、交通状况和实际需要进行审查，作出是否同意筹建的决定。申办人完成拟办企业筹建后，应当向原审批机构申请验收。原审批机构应当自收到申请之日起15个工作日内，依据《药品管理法》第十五条规定的开办条件组织验收；符合条件的，发给《药品经营许可证》。 |
| The health administrative department and the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days from the dates they receive the application respectively, make their own decisions whether or not to consent or approve the application accordingly. | | |
| Article 21 Any medical institution that intends to alter the approved items in the Pharmaceutical Preparation Certificate for Medical Institution shall, 30 days prior to the alteration of any approved items, apply to the original examining and approving departments for registration of alteration according to the provisions in Article 20 of the Regulations; no approved items may be altered without approval. The original examining and approving departments shall make their own decisions within 15 working days from the dates they receive the application respectively. | | 第十三条 省、自治区、直辖市人民政府药品监督管理部门和设区的市级药品监督管理机构负责组织药品经营企业的认证工作。药品经营企业应当按照国务院药品监督管理部门规定的实施办法和实施步骤，通过省、自治区、直辖市人民政府药品监督管理部门或者设区的市级药品监督管理机构组织的《药品经营质量管理规范》的认证，取得认证证书。《药品经营质量管理规范》认证证书的格式由国务院药品监督管理部门统一规定。 |
| Any medical institution which intends to add new dosage forms or change dispensing sites shall, after passing the acceptance inspection by the local drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, go through the registration of alteration of the Pharmaceutical Preparation Certificate for Medical Institution according to the provisions in the preceding paragraph. | | 新开办药品批发企业和药品零售企业，应当自取得《药品经营许可证》之日起30日内，向发给其《药品经营许可证》的药品监督管理部门或者药品监督管理机构申请《药品经营质量管理规范》认证。受理申请的药品监督管理部门或者药品监督管理机构应当自收到申请之日起3个月内，按照国务院药品监督管理部门的规定，组织对申请认证的药品批发企业或者药品零售企业是否符合《药品经营质量管理规范》进行认证；认证合格的，发给认证证书。 |
| Article 22 The valid term of a Pharmaceutical Preparation Certificate for Medical Institution is five years. To continue dispensing pharmaceutical preparation, the medical institution shall, six months prior to the expiry date of the Certificate, apply for the renewal of the Pharmaceutical Preparation Certificate for Medical Institution according to the provisions of the drug regulatory department under the State Council. | | |
| Where a medical institution terminates dispensing Pharmaceutical preparations or is closed down, its Pharmaceutical Preparation Certificate for Medical Institution shall be withdrawn by the original certificate-issuing authority. | | 第十四条 省、自治区、直辖市人民政府药品监督管理部门应当设立《药品经营质量管理规范》认证检查员库。《药品经营质量管理规范》认证检查员必须符合国务院药品监督管理部门规定的条件。进行《药品经营质量管理规范》认证，必须按照国务院药品监督管理部门的规定，从《药品经营质量管理规范》认证检查员库中随机抽取认证检查员组成认证检查组进行认证检查。 |
| Article 23 To dispense a pharmaceutical preparation, the medical institution shall submit the dossier and samples according to the provisions of the drug regulatory department under the State Council, and the pharmaceutical preparation may only be dispensed after being approved by the local drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government and being issued a pharmaceutical preparation approval number. | | |
| Article 24 No pharmaceutical preparations dispensed by medical institutions may be marketed or marketed in disguised forms, nor may any advertisement of such pharmaceutical preparations be released. | | 第十五条 国家实行处方药和非处方药分类管理制度。国家根据非处方药品的安全性，将非处方药分为甲类非处方药和乙类非处方药。 |
| When a major disaster, epidemic situation or any other emergency occurs, or there is an urgent need clinically but no supply of the needed drug in market, the pharmaceutical preparations dispensed by a medical institution may be subject to transfer allocation and use by other designated medical institutions within a specified time limit, upon approval by the drug regulatory department under the State Council or by the drug regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government. | | 经营处方药、甲类非处方药的药品零售企业，应当配备执业药师或者其他依法经资格认定的药学技术人员。经营乙类非处方药的药品零售企业，应当配备经设区的市级药品监督管理机构或者省、自治区、直辖市人民政府药品监督管理部门直接设置的县级药品监督管理机构组织考核合格的业务人员。 |
| Transfer allocation and use of special pharmaceutical preparations regulated by the drug regulatory department under the State Council, and the transfer allocation and use of pharmaceutical preparations dispensed by medical institutions among provinces, autonomous regions, or municipalities directly under the Central Government shall be subject to the approval by the drug regulatory department under the State Council. | | |
| Article 25 Pharmacy personnel of medical institutions who check and dispense prescriptions shall be the pharmaceutical technicians whose qualifications are legally recognized. | | 第十六条 药品经营企业变更《药品经营许可证》许可事项的，应当在许可事项发生变更30日前，向原发证机关申请《药品经营许可证》变更登记；未经批准，不得变更许可事项。原发证机关应当自收到企业申请之日起15个工作日内作出决定。 |
| Article 26 When purchasing drugs, medical institutions shall keep authentic and complete records. In purchase records shall be indicated the adopted name of the drug in China, dosage form, strength, batch number, date of expiry, manufacturer, supplier, purchase volume, purchase price, date of purchase and other items specified by the drug regulatory department under the State Council. | | |
| Article 27 Drugs provided to patients by medical institutions shall be within the scope of diagnoses and treatments and dispensed according to the prescriptions of licensed doctors or licensed assistant doctors. | | 第十七条 《药品经营许可证》有效期为5年。有效期届满，需要继续经营药品的，持证企业应当在许可证有效期届满前6个月，按照国务院药品监督管理部门的规定申请换发《药品经营许可证》。 |
| The scope of drugs purchased and provided to patients by family planning technical service institutions shall be in conformity with the scope of services approved and the drugs shall be dispensed according to the prescriptions of licensed doctors or licensed assistant doctors. | | 药品经营企业终止经营药品或者关闭的，《药品经营许可证》由原发证机关缴销。 |
| Out-patient departments, clinics and any other medical institutions, which are set up by individuals, may not purchase or provide drugs other than those commonly used and those for emergency treatment. The range and category of the drugs commonly used and those for emergency treatment shall be determined by the local health administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government jointly with the drug regulatory department at the same level. | | |
| Chapter V Control over Drugs | | 第十八条 交通不便的边远地区城乡集市贸易市场没有药品零售企业的，当地药品零售企业经所在地县（市）药品监督管理机构批准并到工商行政管理部门办理登记注册后，可以在该城乡集市贸易市场内设点并在批准经营的药品范围内销售非处方药品。 |
| Article 28 Institutions for non-clinical safety evaluation and study of drugs shall implement the Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP) and institutions for drug clinical trial shall implement the Good Clinical Practice (GCP). The GLP and GCP shall be formulated by the drug regulatory department under the State Council through respective consultation with the science and technology administrative department under the State Council and the health administrative department under the State Council. | | |
| Article 29 Clinical trials, manufacturing or importation of drugs shall be in conformity with the provisions in the Drug Administration Law and in the Regulations, and shall be reviewed and approved by the drug regulatory department under the State Council. The drug regulatory department under the State Council may authorize the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government to conduct site inspection of research and development conditions of the drugs being applied, to conduct procedural examination of documents submitted, and to test the pilot samples. The specific measures therefor shall be formulated by the drug regulatory department under the State Council. | | 第十九条 通过互联网进行药品交易的药品生产企业、药品经营企业、医疗机构及其交易的药品，必须符合《药品管理法》和本条例的规定。互联网药品交易服务的管理办法，由国务院药品监督管理部门会同国务院有关部门制定。 |
| Article 30 Any clinical trial to be conducted for research and development of a new drug shall be subject to the approval by the drug regulatory department under the State Council in accordance with the provisions in Article 29 of the Drug Administration Law. | | 第四章 医疗机构的药剂管理 |
| When an application for conducting clinical trials is approved by the drug regulatory department under the State Council, the applicant shall select institutions for clinical trials from the lawfully certified ones to conduct the trials, and make a report thereof to the drug regulatory department and the health administrative department under the State Council for the record. | | |
| Prior to the drug clinical trial, the institution for drug clinical trial shall provide the subjects or their guardians with the truthful information on the trial, and obtain a written informed consent. | | 第二十条 医疗机构设立制剂室，应当向所在地省、自治区、直辖市人民政府卫生行政部门提出申请，经审核同意后，报同级人民政府药品监督管理部门审批；省、自治区、直辖市人民政府药品监督管理部门验收合格的，予以批准，发给《医疗机构制剂许可证》。 |
| Article 31 For production of a drug admitted by national drug standards, an application shall, in accordance with the provisions of the drug regulatory department under the State Council, be submitted to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government or to the drug regulatory department under the State Council, and the relevant technical data and supporting documents shall be provided. The drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days from the date it receives the application, review and make comments, and report the matter to the drug regulatory department under the State Council for review while notifying the applicant of its comments. If all the requirements are fulfilled upon review, a drug approval number shall be issued by the drug regulatory department under the State Council. | | 省、自治区、直辖市人民政府卫生行政部门和药品监督管理部门应当在各自收到申请之日起30个工作日内，作出是否同意或者批准的决定。 |
| Article 32 For modification of any matter stated in the approval document and its attachments for new drug research and development or the production or import of drugs, a supplementary application shall be submitted to the drug administrative department of the State Council; and if all the requirements are satisfied upon review, an approval shall be granted by the drug administrative department of the State Council. If the inherent quality of drugs is not changed, the supplementary application shall be submitted to a drug administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government; and if all the requirements are satisfied upon review, an approval shall be granted by the people's government of the province, autonomous region, or municipality directly under the Central Government, and be submitted to the drug administrative department of the State Council for recordation. The supplementary application matters without changing the inherent quality of drugs shall be determined by the drug administrative department of the State Council. | | |
| Article 33 The drug regulatory department under the State Council may, based on the needs for protection of public health, set an observation period of not more than five years for a new drug produced by a drug manufacturer; and no approval shall be given to any other manufacturer to produce or import the said drug during the observation period. | | 第二十一条 医疗机构变更《医疗机构制剂许可证》许可事项的，应当在许可事项发生变更30日前，依照本条例第二十条的规定向原审核、批准机关申请《医疗机构制剂许可证》变更登记；未经批准，不得变更许可事项。原审核、批准机关应当在各自收到申请之日起15个工作日内作出决定。 |
| Article 34 The State protects undisclosed data of drug study and others which are independently acquired and submitted by drug manufacturers or sellers to obtain production or marketing approval of the drugs in question which contain new chemical entities. No one may make unfair commercial use of the said data. | | 医疗机构新增配制剂型或者改变配制场所的，应当经所在地省、自治区、直辖市人民政府药品监督管理部门验收合格后，依照前款规定办理《医疗机构制剂许可证》变更登记。 |
| Within six years from the date a drug manufacturer or seller obtains the approval documents for producing or marketing a drug containing new chemical entities, if any other applicant uses the data mentioned in the preceding paragraph to apply for approval for production or marketing of the drug in question without permission of the original applicant who has obtained the approval, no approval may be given to any other applicant by the drug regulatory department except that the data submitted are acquired independently. | | |
| No drug regulatory department may disclose the data set forth in the first paragraph of this Article except | | 第二十二条 《医疗机构制剂许可证》有效期为5年。有效期届满，需要继续配制制剂的，医疗机构应当在许可证有效期届满前6个月，按照国务院药品监督管理部门的规定申请换发《医疗机构制剂许可证》。 |
| (1) for the need of public interests; or | | 医疗机构终止配制制剂或者关闭的，《医疗机构制剂许可证》由原发证机关缴销。 |
| (2) where steps are taken to ensure that the data are protected against unfair commercial use. | | |
| Article 35 Any drug applied to be imported shall be the one obtained marketing authorization in the country or region of manufacturing. A drug without such an authorization may be approved of its importation in accordance with the provisions in the Drug Administration Law and in the Regulations, provided that its safety, efficacy and clinical needs have been confirmed by the drug regulatory department under the State Council. | | 第二十三条 医疗机构配制制剂，必须按照国务院药品监督管理部门的规定报送有关资料和样品，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，并发给制剂批准文号后，方可配制。 |
| For importation of a drug, an application for registration shall be made according to the provisions of the drug regulatory department under the State Council. A drug may only be imported after an Import Drug License is given if it is produced by a foreign manufacturer, or a Pharmaceutical Product License is given if it is produced by a manufacturer in Hong Kong, Macao or Taiwan of China. | | |
| Article 36 Any medical institution that urgently needs to import a small amount of drugs shall, with a Practicing License of Medical Institution, submit an application to the drug regulatory department under the State Council, and the drugs in question may only be imported upon approval. Such import drugs shall only be used in the designated medical institution for specified purpose. | | 第二十四条 医疗机构配制的制剂不得在市场上销售或者变相销售，不得发布医疗机构制剂广告。 |
| Article 37 After import drugs arrive at the port, the drug importer shall file a record with the local drug regulatory department in the place where the port is located with the Import Drug License or Pharmaceutical Product License, the original copy of the certificate of origin, duplicate copy of the purchase contract, packing list, bill of freight, shipping invoice, certificate of analysis for the release of drugs by the manufacturer, insert sheet and other documents. The said drug regulatory department shall review the documents submitted and issue a Drug Import Note if they comply with the requirements. The drug importer shall, with the Drug Import Note, complete the formalities for customs declaration and clearance with the Customs. | | 发生灾情、疫情、突发事件或者临床急需而市场没有供应时，经国务院或者省、自治区、直辖市人民政府的药品监督管理部门批准，在规定期限内，医疗机构配制的制剂可以在指定的医疗机构之间调剂使用。 |
| The drug regulatory department in the place where the port is located shall notify the drug testing institution to conduct sampling and testing of the import drugs on each batch basis with the exception of the circumstances set forth in Article 41 of the Drug Administration Law. | | 国务院药品监督管理部门规定的特殊制剂的调剂使用以及省、自治区、直辖市之间医疗机构制剂的调剂使用，必须经国务院药品监督管理部门批准。 |
| Article 38 Vaccines, blood products, diagnostic reagents in vitro for blood donor screening and other biological products regulated by the drug regulatory department under the State Council shall be subject to testing or review for approval according to the provisions of the drug regulatory department under the State Council before being marketed or imported; any product that fails in testing or has not been approved shall not be marketed or imported. | | |
| Article 39 The State encourages cultivation of Chinese crude drugs. Control through approval number shall be exercised over the Chinese crude drugs that can be cultivated or raised on a large scale and in an intensified way and whose quality can be controlled and fulfills the requirements laid down by the drug regulatory department under the State Council. | | 第二十五条 医疗机构审核和调配处方的药剂人员必须是依法经资格认定的药学技术人员。 |
| Article 40 The drug regulatory department under the State Council shall re-evaluate the drugs approved for production and marketing and, on the basis of the re-evaluation results, may take measures to order the revision of insert sheet or suspension of production, marketing or use of a drug, or withdraw the approval documents of drugs with serious adverse reaction or harmful to human health due to other reasons. | | |
| Article 41 The valid term of a drug approval number, Import Drug License and Pharmaceutical Product License issued by the drug regulatory department under the State Council is five years. To continue its drug production or importation, the applicant shall submit a reregistration application six months prior to the expiry date. When making re-registration of a drug, the applicant shall submit the relevant data according to the provisions of the drug regulatory department under the State Council. If no application for the re-registration of a drug is made upon expiration of the valid term, or the application fails to comply with the provisions on re-registration of the drug regulatory department under the State Council upon review, the drug approval number, Import Drug License or Pharmaceutical Product License shall be withdrawn. | | 第二十六条 医疗机构购进药品，必须有真实、完整的药品购进记录。药品购进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、供货单位、购货数量、购进价格、购货日期以及国务院药品监督管理部门规定的其他内容。 |
| The re-registration of drug approval documents shall be subject to the approval of the drug administrative department of the people's government of a province, autonomous region, or municipality directly under the Central Government and be submitted to the drug administrative department of the State Council for recordation; and the re-registration of the Imported Drug License and the Certificate of Pharmaceutical Product shall be subject to the approval of the drug administrative department of the State Council. | | |
Article 42 No contents involving prevention, treatment or diagnosis of human diseases shall be included in the package, label or insert sheet and the related promotional materials for promoting a non-drug product, except as otherwise provided by laws or administrative regulations.
．．．．．． | | 第二十七条 医疗机构向患者提供的药品应当与诊疗范围相适应，并凭执业医师或者执业助理医师的处方调配。
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