法律文本

中華人民共和國藥品管理法（2015修訂）

Drug Administration Law of the People's Republic of China (Revision 2015)

(1984年9月20日第六屆全國人民代表大會常務委員會第七次會議通過 2001年2月28日第九屆全國人民代表大會常務委員會第二十次會議修訂根據 2013年12月28日第十二屆全國人民代表大會常務委員會第六次會議《關於修改等七部法律的決定》第一次修正 根據2015年4月24日第十二屆全國人民代表大會常務委員會第十四次會議《關於修改的決定》第二次修正)

(Adopted at the 7th Meeting of the Standing Committee of the 6th National People's Congress on September 20, 1984; revised at the 20th Meeting of the Standing Committee of the 9th National People's Congress on February 28, 2001; amended for the first time according to the Decision on Amending Seven Laws passed at the 6th Meeting of the Standing Committee of the 12th National People's Congress on December 28, 2013; and amended for the second time according to the Decision on Amending Seven Laws passed at the 14th Meeting of the Standing Committee of the 12th National People's Congress on April 24, 2015)

  第一章 總則

Chapter 1 General Provisions

  第二章 藥品生產企業管理

Chapter 2 Administration of Pharmaceutical Producing Enterprises

  第三章 藥品經營企業管理

Chapter 3 Administration of Pharmaceutical Trading Enterprises

  第四章 醫療機構的藥劑管理

Chapter 4 Control over Pharmaceuticals in Medical Institutions

  第五章 藥品管理

Chapter 5 Administration over Drugs

  第六章 藥品包裝的管理

Chapter 6 Drug Packaging Management

  第七章 藥品價格和廣告的管理

Chapter 7 Drug Pricing and Advertising Management

  第八章 藥品監督

Chapter 8 Drug Supervision

  第九章 法律責任

Chapter 9 Legal Liabilities

  第十章 附則

Chapter 10 Supplementary Provisions

第一章 總則

Chapter 1 General Provisions

第一條   為加強藥品監督管理，保證藥品質量，保障人體用藥安全，維護人民身體健康和用藥的合法權益，特制定本法。

Article 1. This Law is formulated in order to strengthen drug control and administration, ensure the quality of drugs, guarantee safe drug use for human beings and safeguard the health of the people and their legal rights and interests in drug use.

第二條   在中華人民共和國境內從事藥品的研制、生產、經營、使用和監督管理的單位或者個人，必須遵守本法。

Article 2 All entities and individuals engaged in research, production, distribution and use of, and supervision and administration over, drugs within the territory of the People's Republic of China shall comply with the Law.

第三條   國家發展現代藥和傳統藥，充分發揮其在預防、醫療和保健中的作用。

Article 3 The State develops both modern and traditional medicines to give full play to their role in the prevention and treatment of diseases and in health care.

國家保護野生藥材資源，鼓勵培育中藥材。

The State protects the resources of wild medicinal materials and encourages the cultivation of Chinese traditional medicinal materials.

第四條   國家鼓勵研究和創制新藥，保護公民、法人和其他組織研究、開發新藥的合法權益。

The State encourages the research and development of new drugs and protects the legal rights and interests of citizens, legal persons and other organisations in the research and development of new drugs.

第五條   國務院藥品監督管理部門主管全國藥品監督管理工作。國務院有關部門在各自的職責範圍內負責與藥品有關的監督管理工作。

Article 5 The drug regulatory department under the State Council is responsible for drug supervision and administration nationwide. Other relevant departments under the State Council are responsible for the supervision and control of pharmaceuticals related to the scope of their functions.

省、自治區、直轄市人民政府藥品監督管理部門負責本行政區域內的藥品監督管理工作。省、自治區、直轄市人民政府有關部門在各自的職責範圍內負責與藥品有關的監督管理工作。

The drug control and administration departments of the people's governments of a province, autonomous region or centrally administered municipality are responsible for drug control and administration within their administrative regions. The relevant departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the supervision and control of pharmaceuticals related to the scope of their functions.

國務院藥品監督管理部門應當配合國務院經濟綜合主管部門，執行國家制定的藥品行業發展規劃和產業政策。

The drug regulatory department under the State Council shall cooperate with the comprehensive economic department under the State Council in implementing the pharmaceutical development plan and industrial policies formulated by the State.

第六條   藥品監督管理部門設置或者確定的藥品檢驗機構，承擔依法實施藥品審批和藥品質量監督檢查所需的藥品檢驗工作。

Article 6 The pharmaceutical inspection institutions established or designated by the pharmaceutical supervisory and administrative departments shall be responsible for the examination and approval of pharmaceuticals and the supervision and inspection of pharmaceutical quality in accordance with laws.

第二章 藥品生產企業管理

Chapter 2 Administration of Pharmaceutical Producing Enterprises

第七條   開辦藥品生產企業，須經企業所在地省、自治區、直轄市人民政府藥品監督管理部門批準並發給《藥品生產許可證》。無《藥品生產許可證》的，不得生產藥品。

Article 7. The establishment of a drug -producing enterprise must be approved by, and the Drug Production Licence shall be issued by, the drug control and administrative department of the people's government of a province, autonomous region or centrally administered municipality in which the enterprise is located. No drug production is permitted without the Drug Production Licence.

《藥品生產許可證》應當標明有效期和生產範圍，到期重新審查發證。

The Pharmaceutical Production License shall bear the scope of production and a period of validity, and upon expiration a new license shall be issued after examination for its renewal.

藥品監督管理部門批準開辦藥品生產企業，除依據本法第八條規定的條件外，還應當符合國家制定的藥品行業發展規劃和產業政策，防止重複建設。

Apart from the provisions in Article 8 of this Law, the approval of the establishment of a drug-producing enterprise by the drug control and administration department shall be in accordance with the development plans for the drug industry and the industrial policies stipulated by the State and shall avoid duplication.

第八條   開辦藥品生產企業，必須具備以下條件:

Article 8 To establish a pharmaceutical producing enterprise, the following requirements must be met:

（一）具有依法經過資格認定的藥學技術人員、工程技術人員及相應的技術工人；

1. having legally qualified pharmaceutical professionals, engineering professionals, and the corresponding technical workers;

（二）具有與其藥品生產相適應的廠房、設施和衛生環境；

(II) having plant, facilities and sanitary environment suitable for its pharmaceutical production;

（三）具有能對所生產藥品進行質量管理和質量檢驗的機構、人員以及必要的儀器設備；

(III) having the organization, personnel and necessary instruments and equipment capable of quality control and inspection for the drugs produced;

（四）具有保證藥品質量的規章制度。

4. having rules and regulations to ensure the quality of drugs.

第九條   藥品生產企業必須按照國務院藥品監督管理部門依據本法制定的《藥品生產質量管理規範》組織生產。藥品監督管理部門按照規定對藥品生產企業是否符合《藥品生產質量管理規範》的要求進行認證；對認證合格的，發給認證證書。

Article 9. Drug-producing enterprises must organise their production in accordance with the Standards for Quality Control of Drug Production stipulated by the drug control and administrative department of the State Council on the basis of this Law. The drug control and administrative departments shall, in accordance with the regulations, conduct assessment in regard to whether or not a drug-producing enterprise meets the requirements of the Standards for Quality Control of Drug Production and shall issue assessment certificates to those which pass the assessment.

《藥品生產質量管理規範》的具體實施辦法、實施步驟由國務院藥品監督管理部門規定。

The specific measures and schedule for implementing the GMP shall be formulated by the drug regulatory department under the State Council.

第十條   除中藥飲片的炮制外，藥品必須按照國家藥品標準和國務院藥品監督管理部門批準的生產工藝進行生產，生產記錄必須完整準確。藥品生產企業改變影響藥品質量的生產工藝的，必須報原批準部門審核批準。

Article 10 Except for the preparation of Chinese medicines into ready-to-use forms, pharmaceuticals must be produced in accordance with the national pharmaceutical standard and the technological procedures approved by the supervisory and administrative departments of pharmaceuticals under the State Council, and the record of production must be complete and accurate. If a drug-producing enterprise makes changes in the technological processes affecting the quality of the drugs, the enterprise must submit the changes for examination and approval to the original approval authorities.

中藥飲片必須按照國家藥品標準炮制；國家藥品標準沒有規定的，必須按照省、自治區、直轄市人民政府藥品監督管理部門制定的炮制規範炮制。省、自治區、直轄市人民政府藥品監督管理部門制定的炮制規範應當報國務院藥品監督管理部門備案。

The prepared slices of traditional Chinese drugs shall be processed in conformity with the national drug standards. Those not covered by the national drug standards shall be processed in accordance with the processing standards formulated by the drug regulatory departments of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government. The said processing norms shall be submitted to the drug regulatory department under the State Council for the record.

第十一條   生產藥品所需的原料、輔料，必須符合藥用要求。

Article 11 The raw and supplementary materials used for the production of pharmaceuticals must conform to the requirements for medicinal use.

第十二條   藥品生產企業必須對其生產的藥品進行質量檢驗；不符合國家藥品標準或者不按照省、自治區、直轄市人民政府藥品監督管理部門制定的中藥飲片炮制規範炮制的，不得出廠。

Article 12. Drug-producing enterprises must conduct quality tests on the drugs they produce. Where the drugs do not comply with the state drug standards or the processing standards for the processing of Chinese medicinal liquids and tablets stipulated by the drug control and administrative department of the people's government of a province, autonomous region or centrally administered municipality, the drugs must not leave the factory.

第十三條   經省、自治區、直轄市人民政府藥品監督管理部門批準，藥品生產企業可以接受委托生產藥品。

Article 13. With the approval of the drug control and administrative department of the people's government of a province, autonomous region or centrally administered municipality, drug-producing enterprises may accept commissions to produce drugs.

第三章 藥品經營企業管理

Chapter 3 Administration of Pharmaceutical Trading Enterprises

第十四條   開辦藥品批發企業，須經企業所在地省、自治區、直轄市人民政府藥品監督管理部門批準並發給《藥品經營許可證》；開辦藥品零售企業，須經企業所在地縣級以上地方藥品監督管理部門批準並發給《藥品經營許可證》。無《藥品經營許可證》的，不得經營藥品。

Article 14. The establishment of a drug - wholesaling enterprise must be approved by the drug control and administrative department of the people's government of a province, autonomous region or centrally administered municipality where the enterprise is located, and must obtain the Drug-trading Licence. The establishment of a drug retailing enterprise must be approved by the local drug control and administrative department at county level or above where the enterprise is located, and the Drug-trading Licence must be obtained. No one is allowed to distribute drugs without a Drug Distribution Certificate.

《藥品經營許可證》應當標明有效期和經營範圍，到期重新審查發證。

A Pharmaceutical Trade License shall bear a scope of business and a period of validity, and upon expiration a new license shall be issued after examination for its renewal.

藥品監督管理部門批準開辦藥品經營企業，除依據本法第十五條規定的條件外，還應當遵循合理布局和方便群眾購藥的原則。

Apart from the provisions in Article 15 of this Law, the approval of the establishment of a pharmaceutical trading enterprise by the pharmaceutical supervisory and administrative departments shall follow the principle of rational location and convenience for buying of pharmaceuticals by the people.

第十五條   開辦藥品經營企業必須具備以下條件:

Article 15 A drug distributor to be established shall meet the following requirements:

（一）具有依法經過資格認定的藥學技術人員；

1. having legally qualified pharmaceutical professionals;

（二）具有與所經營藥品相適應的營業場所、設備、倉儲設施、衛生環境；

(II) It shall have business premises, equipment, warehouse facilities and sanitary conditions suitable for the pharmaceuticals in which it trades.

（三）具有與所經營藥品相適應的質量管理機構或者人員；

(III) It shall have a quality control organ or personnel suitable for the pharmaceuticals in which it trades.

（四）具有保證所經營藥品質量的規章制度。

(IV) It shall have rules and regulations designed to ensure the quality of pharmaceuticals in which it trades.

第十六條   藥品經營企業必須按照國務院藥品監督管理部門依據本法制定的《藥品經營質量管理規範》經營藥品。藥品監督管理部門按照規定對藥品經營企業是否符合《藥品經營質量管理規範》的要求進行認證；對認證合格的，發給認證證書。

Article 16 Drug distributors shall conduct drug distribution in accordance with the Good Distribution Practice for Drugs formulated by the drug regulatory department under the State Council based on the Law. The drug regulatory departments shall inspect a drug distributor for its compliance with the requirements of the Good Distribution Practice for Drugs, and issue a certificate to the distributor passing the inspection.

《藥品經營質量管理規範》的具體實施辦法、實施步驟由國務院藥品監督管理部門規定。

The specific measures and schedule for implementing the GSP shall be formulated by the drug regulatory department under the State Council.

第十七條   藥品經營企業購進藥品，必須建立並執行進貨檢查驗收制度，驗明藥品合格證明和其他標識；不符合規定要求的，不得購進。

Article 17. On purchasing drugs, a drug-trading enterprise must establish and implement a system of stock inspection and acceptance. Quality certificates and other labels of the drugs must be verified. Where drugs do not satisfy the stipulated requirements, they may not be purchased.

第十八條   藥品經營企業購銷藥品，必須有真實完整的購銷記錄。購銷記錄必須注明藥品的通用名稱、劑型、規格、批號、有效期、生產廠商、購（銷）貨單位、購（銷）貨數量、購銷價格、購（銷）貨日期及國務院藥品監督管理部門規定的其他內容。

Article 18 Pharmaceutical trading enterprises shall keep accurate and complete records of purchased pharmaceuticals. Purchase and sale records shall indicate the generic name of the drug, dosage form, specification, batch number, expiry date, manufacturer, purchasing (selling) unit, purchasing (selling) quantity, purchasing and selling price, purchasing (selling) date and other items specified by the drug regulatory department under the State Council.

第十九條   藥品經營企業銷售藥品必須準確無誤，並正確說明用法、用量和注意事項；調配處方必須經過核對，對處方所列藥品不得擅自更改或者代用。對有配伍禁忌或者超劑量的處方，應當拒絕調配；必要時，經處方醫師更正或者重新簽字，方可調配。

Article 19. Drugs sold by a drug-trading enterprise must be presented correctly; the method of use, dosage and points to note must be explained precisely. In making up prescriptions, checks must be carried out; the drugs itemised in the prescription must not be altered or substituted without authorisation. Where a prescription contains ingredients 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 or signed it again, it may be made up.

藥品經營企業銷售中藥材，必須標明產地。

When traditional Chinese medicinal materials are offered for sale by pharmaceutical trading enterprises, their origin must be indicated.

第二十條   藥品經營企業必須制定和執行藥品保管制度，采取必要的冷藏、防凍、防潮、防蟲、防鼠等措施，保證藥品質量。

Article 20 Rules for storage of pharmaceuticals shall be formulated and implemented by pharmaceutical trading enterprises, which must adopt necessary measures to facilitate cold storage and protection against freeze, moisture, insects and rodents to ensure pharmaceutical quality.

藥品入庫和出庫必須執行檢查制度。

An inspection system shall be carried out in relation to drugs which are brought into or removed from the warehouse.

第二十一條   城鄉集市貿易市場可以出售中藥材，國務院另有規定的除外。

Article 21. Chinese medicinal materials may be sold at urban or rural fairs, except as otherwise stipulated by the State.

城鄉集市貿易市場不得出售中藥材以外的藥品，但持有《藥品經營許可證》的藥品零售企業在規定的範圍內可以在城鄉集市貿易市場設點出售中藥材以外的藥品。具體辦法由國務院規定。

No drugs other than the traditional Chinese drugs may be sold at urban or rural trade markets, but drug retailers holding a Drug Distribution Certificate may, within the specified scope, sell such drugs at stores they set up at urban or rural trade markets. The specific measures shall be formulated by the State Council.

第四章 醫療機構的藥劑管理

Chapter 4 Control over Pharmaceuticals in Medical Institutions

第二十二條   醫療機構必須配備依法經過資格認定的藥學技術人員。非藥學技術人員不得直接從事藥劑技術工作。

Article 22 A medical institution shall be staffed with legally qualified pharmaceutical professionals. No one other than a pharmaceutical technician may directly engage in technical work in pharmacy.

第二十三條   醫療機構配制制劑，須經所在地省、自治區、直轄市人民政府衛生行政部門審核同意，由省、自治區、直轄市人民政府藥品監督管理部門批準，發給《醫療機構制劑許可證》。無《醫療機構制劑許可證》的，不得配制制劑。

Article 23 To dispense pharmaceutical preparations, a medical institution shall be subject to examination and approval by the administrative department for health of the people's government of the province, autonomous region or municipality directly under the Central Government where the medical institution is located, and upon approval by the drug regulatory department of the said people's government, a Pharmaceutical Preparation Certificate for Medical Institution shall be issued to the medical institution. No medicinal preparations shall be made without a Dispensing Permit for Medical Organizations.

《醫療機構制劑許可證》應當標明有效期，到期重新審查發證。

The valid term shall be indicated in a Pharmaceutical Preparation Certificate for Medical Institution. For renewal of the certificate upon expiration, reexamination is required.

第二十四條   醫療機構配制制劑，必須具有能夠保證制劑質量的設施、管理制度、檢驗儀器和衛生條件。

Article 24 To dispense pharmaceutical preparations, a medical institution shall have the facilities, management system, testing instruments and sanitary conditions for ensuring their quality.

第二十五條   醫療機構配制的制劑，應當是本單位臨床需要而市場上沒有供應的品種，並須經所在地省、自治區、直轄市人民政府藥品監督管理部門批準後方可配制。配制的制劑必須按照規定進行質量檢驗；合格的，憑醫師處方在本醫療機構使用。特殊情況下，經國務院或者省、自治區、直轄市人民政府的藥品監督管理部門批準，醫療機構配制的制劑可以在指定的醫療機構之間調劑使用。

Article 25 The pharmaceutical preparations to be dispensed by a medical institution shall be those meeting the clinical need of the institution but not available on the market and shall be subject to prior approval by the local drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government. The quality of the medicinal preparations made by medical organizations must be inspected in accordance with relevant regulations. Those preparations conforming to standard can be used as the doctor prescribes. Under special circumstances, with the approval of the pharmaceutical supervisory and administrative departments of the State Council or of the provinces, autonomous regions and municipalities directly under the central government, the pharmaceutical preparations dispensed by medical organizations can be used by other designated medical organizations.

醫療機構配制的制劑，不得在市場銷售。

No pharmaceutical preparations dispensed by medical institutions may be marketed.

第二十六條   醫療機構購進藥品，必須建立並執行進貨檢查驗收制度，驗明藥品合格證明和其他標識；不符合規定要求的，不得購進和使用。

Article 26 When purchasing pharmaceuticals, medical organizations must establish and implement a system of quality inspection and check the certificates and other marks of pharmaceuticals. Those pharmaceuticals that do not meet the requirements of relevant regulations must not be purchased and used.

第二十七條   醫療機構的藥劑人員調配處方，必須經過核對，對處方所列藥品不得擅自更改或者代用。對有配伍禁忌或者超劑量的處方，應當拒絕調配；必要時，經處方醫師更正或者重新簽字，方可調配。

Article 27 Prescriptions being dispensed by pharmacists of medical institutions shall be checked, and no drug listed therein may be changed or substituted without authorization. Where a prescription contains ingredients 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 or signed it again, it may be made up.

第二十八條   醫療機構必須制定和執行藥品保管制度，采取必要的冷藏、防凍、防潮、防蟲、防鼠等措施，保證藥品質量。

Article 28 A medical institution shall establish and apply a system for drug storage, and take necessary measures to ensure the quality of drugs, such as cold storage, protection against freeze and humidity and avoidance of insects and rodents.

第五章 藥品管理

Chapter 5 Administration over Drugs

第二十九條   研制新藥，必須按照國務院藥品監督管理部門的規定如實報送研制方法、質量指標、藥理及毒理試驗結果等有關資料和樣品，經國務院藥品監督管理部門批準後，方可進行臨床試驗。藥物臨床試驗機構資格的認定辦法，由國務院藥品監督管理部門、國務院衛生行政部門共同制定。

Article 29. Where a new drug has been researched and developed, in accordance with the regulations set down by the drug control and administrative department of the State Council, a report must be submitted, together with samples, giving details of the method of research and development, quality norms, results of pharmacological and toxicological tests and other relevant data. A clinical test can be carried out only after approval has been obtained from the drug control and administrative department of the State Council. Measures for verifying the qualifications of clinical drug trial institutions shall be jointly formulated by the drug regulatory department and the administrative department for health under the State Council.

完成臨床試驗並通過審批的新藥，由國務院藥品監督管理部門批準，發給新藥證書。

Where a new drug has completed its clinical tests and passed the examination and approval, a new drug certificate shall be issued upon approval by the drug control and administrative department of the State Council.

第三十條   藥物的非臨床安全性評價研究機構和臨床試驗機構必須分別執行藥物非臨床研究質量管理規範、藥物臨床試驗質量管理規範。

Article 30 Institutions for non-clinical safety evaluation and research of drugs and institutions for clinical trial of drugs shall respectively implement quality management standards for non-clinical drug research and quality management standards for clinical drug trials.

藥物非臨床研究質量管理規範、藥物臨床試驗質量管理規範由國務院確定的部門制定。

The good practices of non-clinical drug research and good practices of clinical drug trials shall be formulated by the department designated by the State Council.

第三十一條   生產新藥或者已有國家標準的藥品的，須經國務院藥品監督管理部門批準，並發給藥品批準文號；但是，生產沒有實施批準文號管理的中藥材和中藥飲片除外。實施批準文號管理的中藥材、中藥飲片品種目錄由國務院藥品監督管理部門會同國務院中醫藥管理部門制定。

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, with the exception of the traditional Chinese medicines and the prepared slices of traditional Chinese medicines over which no control by registered document of approval is exercised. The drug regulatory department under the State Council shall, in concert with the administrative department for traditional Chinese medicines under the State Council, formulate the catalogue of varieties of traditional Chinese medicinal materials and Chinese herbal medicines subject to approval number control.

藥品生產企業在取得藥品批準文號後，方可生產該藥品。

A drug manufacturer may produce the drug only after an approval number is obtained.

第三十二條   藥品必須符合國家藥品標準。中藥飲片依照本法第十條第二款的規定執行。

Article 32 Pharmaceuticals must meet the pharmaceutical standards of the State. The provisions of paragraph 2 of Article 10 of the Law apply to the prepared slices of traditional Chinese drugs.

國務院藥品監督管理部門頒布的《中華人民共和國藥典》和藥品標準為國家藥品標準。

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.

國務院藥品監督管理部門組織藥典委員會，負責國家藥品標準的制定和修訂。

The pharmaceutical supervisory and administrative department under the State Council shall organize the Pharmacopoeia Committee which shall be responsible for the formulation and revision of the state pharmaceutical standards.

國務院藥品監督管理部門的藥品檢驗機構負責標定國家藥品標準品、對照品。

The drug testing institutions of the drug regulatory department under the State Council are responsible for defining the national drug standard substance and reference substance.

第三十三條   國務院藥品監督管理部門組織藥學、醫學和其他技術人員，對新藥進行審評，對已經批準生產的藥品進行再評價。

Article 33. The drug control and administrative department of the State Council shall organise pharmaceutical, medical and other technical personnel to evaluate new drugs and re-evaluate drugs which have already been approved for production.

第三十四條   藥品生產企業、藥品經營企業、醫療機構必須從具有藥品生產、經營資格的企業購進藥品；但是，購進沒有實施批準文號管理的中藥材除外。

Article 34. Drug-producing enterprises, drug-trading enterprises and medical organisations must purchase drugs from enterprises which are qualified to produce and trade drugs. However, the purchase of the Chinese medicinal materials which are not controlled under the approval number system is excepted.

第三十五條   國家對麻醉藥品、精神藥品、醫療用毒性藥品、放射性藥品，實行特殊管理。管理辦法由國務院制定。

Article 35 The State exercises special control over narcotic drugs, psychotropic substances, toxic drugs for medical use and radioactive drugs. Administrative measures shall be formulated by the State Council.

第三十六條   國家實行中藥品種保護制度。具體辦法由國務院制定。

Article 36 The State adopts a protection system for certain traditional Chinese medicines. Specific measures shall be formulated by the State Council.

第三十七條   國家對藥品實行處方藥與非處方藥分類管理制度。具體辦法由國務院制定。

Article 37 The State adopts a classification system for prescription and non-prescription drugs. Specific measures shall be formulated by the State Council.

第三十八條   禁止進口療效不確、不良反應大或者其他原因危害人體健康的藥品。

Article 38 Import of medicines whose curative effects are uncertain or poor, or which produce adverse reactions or have other harmful effects on human health shall be prohibited.

第三十九條   藥品進口，須經國務院藥品監督管理部門組織審查，經審查確認符合質量標準、安全有效的，方可批準進口，並發給進口藥品注冊證書。

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.

醫療單位臨床急需或者個人自用進口的少量藥品，按照國家有關規定辦理進口手續。

Medicines to be imported in small quantities for urgent clinical needs by medical institutions or for personal use shall go through import formalities in accordance with the relevant regulations of the State.

第四十條   藥品必須從允許藥品進口的口岸進口，並由進口藥品的企業向口岸所在地藥品監督管理部門登記備案。海關憑藥品監督管理部門出具的《進口藥品通關單》放行。無《進口藥品通關單》的，海關不得放行。

Article 40 Drugs shall be imported via the ports where drug importation is permitted, and registered for the record by the drug importers with the drug regulatory departments in the places where the ports are located. The customs shall release the drugs based on the Drug Import Note issued by the said departments. Those without the Import Pharmaceuticals Customs Form shall not be permitted to pass through Customs.

口岸所在地藥品監督管理部門應當通知藥品檢驗機構按照國務院藥品監督管理部門的規定對進口藥品進行抽查檢驗，並依照本法第四十一條第二款的規定收取檢驗費。

The pharmaceutical supervisory and administrative departments where the ports are located shall notify the pharmaceutical inspection institutions 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 shall charge inspection fees according to Article 41 (2) of this Law.

允許藥品進口的口岸由國務院藥品監督管理部門會同海關總署提出，報國務院批準。

The ports which are permitted to import drugs shall be jointly nominated by the drug control and administrative department of the State Council and the General Administration of Customs, and approved by the State Council.

第四十一條   國務院藥品監督管理部門對下列藥品在銷售前或者進口時，指定藥品檢驗機構進行檢驗；檢驗不合格的，不得銷售或者進口:

Article 41 The drug regulatory department under the State Council shall designate drug testing institutions to test the following drugs before they are marketed or at the time they are imported; no drugs that fail to pass the testing may be marketed or imported:

（一）國務院藥品監督管理部門規定的生物制品；

1. biological products specified by the drug regulatory department under the State Council;

（二）首次在中國銷售的藥品；

(II) Drugs to be sold in China for the first time; or

（三）國務院規定的其他藥品。

(III) other pharmaceuticals prescribed by the State Council.

前款所列藥品的檢驗費項目和收費標準由國務院財政部門會同國務院價格主管部門核定並公告。檢驗費收繳辦法由國務院財政部門會同國務院藥品監督管理部門制定。

The testing items to be charged for the drugs listed in the preceding paragraph and the charging rates shall be ratified and announced by the financial department under the State Council in concert with the competent price department under the State Council. The measures for collecting inspection fees shall be formulated by the financial department under the State Council jointly with the drug regulatory department under the State Council.

第四十二條   國務院藥品監督管理部門對已經批準生產或者進口的藥品，應當組織調查；對療效不確、不良反應大或者其他原因危害人體健康的藥品，應當撤銷批準文號或者進口藥品注冊證書。

Article 42 The pharmaceutical supervisory and administrative department under the State Council shall organize investigations on medicines which have been approved for production or importation. It shall revoke the registered documents of approval or the registered certificate of import if it discovers that the medicines' curative effects are uncertain or poor, that they produce serious adverse reactions, or that for other reasons they are harmful to people's health.

已被撤銷批準文號或者進口藥品注冊證書的藥品，不得生產或者進口、銷售和使用；已經生產或者進口的，由當地藥品監督管理部門監督銷毀或者處理。

No drugs whose approval numbers or import drug licenses have been revoked may be produced, imported, sold or used. Those already produced or imported shall be destroyed or disposed of under the supervision of the local drug regulatory departments.

第四十三條   國家實行藥品儲備制度。

Article 43 The State adopts a system for drug reserve.

國內發生重大災情、疫情及其他突發事件時，國務院規定的部門可以緊急調用企業藥品。

In case of serious disasters, epidemic situations and other emergencies, the department prescribed by the State Council may transfer drugs from enterprises to meet such emergencies.

第四十四條   對國內供應不足的藥品，國務院有權限制或者禁止出口。

Article 44. The State Council has the power to restrict or prohibit the export of drugs in insufficient supply for the domestic market.

第四十五條   進口、出口麻醉藥品和國家規定範圍內的精神藥品，必須持有國務院藥品監督管理部門發給的《進口準許證》、《出口準許證》。

Article 45 Anyone who wishes to import or export narcotic drugs and psychotropic substances that fall within the scope specified by the State shall produce the Import License or Export License issued by the drug regulatory department under the State Council.

第四十六條   新發現和從國外引種的藥材，經國務院藥品監督管理部門審核批準後，方可銷售。

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 regulatory department under the State Council.

第四十七條   地區性民間習用藥材的管理辦法，由國務院藥品監督管理部門會同國務院中醫藥管理部門制定。

Article 47 Administrative measures for the folk crude drugs customarily used in certain regions shall be formulated by the drug regulatory department under the State Council in concert with the administrative department for traditional Chinese medicines under the State Council.

第四十八條   禁止生產（包括配制，下同）、銷售假藥。

Article 48 Production (including dispensing, hereinafter the same) and sale of counterfeit drugs are prohibited.

有下列情形之一的，為假藥:

A fake medicine has any one of the following characteristics:

（一）藥品所含成份與國家藥品標準規定的成份不符的；

1. the ingredients in the drug are inconsistent with those specified by the national drug standards;

（二）以非藥品冒充藥品或者以他種藥品冒充此種藥品的。

(II) a non-drug substance is passed off as a drug, or one drug is passed off as another.

有下列情形之一的藥品，按假藥論處:

A medicine shall be handled as fake medicine in any of the following cases:

（一）國務院藥品監督管理部門規定禁止使用的；

1. the use is prohibited by the provisions of the drug regulatory department under the State Council;

（二）依照本法必須批準而未經批準生產、進口，或者依照本法必須檢驗而未經檢驗即銷售的；

(II) Producing or importing goods or selling goods without being approved or inspected as required by this Law;

（三）變質的；

(III) it has deteriorated;

（四）被汙染的；

(IV) being polluted;

（五）使用依照本法必須取得批準文號而未取得批準文號的原料藥生產的；

(V) it is produced by using crude drugs without approval numbers as required by the Law; and

（六）所標明的適應症或者功能主治超出規定範圍的。

(VI) The indications or functions indicated are beyond the specified scope.

第四十九條   禁止生產、銷售劣藥。

Article 49. It is prohibited to produce or sell inferior drugs.

藥品成份的含量不符合國家藥品標準的，為劣藥。

A drug with content not up to the national drug standards is a substandard drug.

有下列情形之一的藥品，按劣藥論處:

A drug shall be treated as a substandard drug in any of the following cases:

（一）未標明有效期或者更改有效期的；

1. the expiration date is not indicated or is altered;

（二）不注明或者更改生產批號的；

2. the batch number is not indicated or is altered;

（三）超過有效期的；

3. the medicine has passed its expiry date;

（四）直接接觸藥品的包裝材料和容器未經批準的；

(IV) the packaging materials or containers in direct contact with drugs have not been approved;

（五）擅自添加著色劑、防腐劑、香料、矯味劑及輔料的；

(V) colorants, preservatives, spices, flavorings and accessories are added without authorization;

（六）其他不符合藥品標準規定的。

(VI) The medicine fails to meet the prescribed standards in other respects.

第五十條   列入國家藥品標準的藥品名稱為藥品通用名稱。已經作為藥品通用名稱的，該名稱不得作為藥品商標使用。

Article 50 The names of the drugs listed in the national drug standards shall be the generic names of the drugs. Such a common name may not be used as a trademark of the drug.

第五十一條   藥品生產企業、藥品經營企業和醫療機構直接接觸藥品的工作人員，必須每年進行健康檢查。患有傳染病或者其他可能汙染藥品的疾病的，不得從事直接接觸藥品的工作。

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. Those who suffer from infectious diseases or other diseases that may contaminate drugs may not engage in work involving direct contact with drugs.

第六章 藥品包裝的管理

Chapter 6 Drug Packaging Management

第五十二條   直接接觸藥品的包裝材料和容器，必須符合藥用要求，符合保障人體健康、安全的標準，並由藥品監督管理部門在審批藥品時一並審批。

Article 52 Packaging materials and containers in direct contact with drugs shall meet the requirements for medicinal use and the standards for ensuring human health and safety, and shall, along with the drugs, be subject to examination and approval by the drug regulatory departments.

藥品生產企業不得使用未經批準的直接接觸藥品的包裝材料和容器。

Drug-producing enterprises must not use unapproved packing materials or containers which have direct contact with drugs.

對不合格的直接接觸藥品的包裝材料和容器，由藥品監督管理部門責令停止使用。

The drug control and administrative department shall order suspension of the use of rejected packaging materials and containers which have direct contact with drugs.

第五十三條   藥品包裝必須適合藥品質量的要求，方便儲存、運輸和醫療使用。

Article 53 Packaging must meet the specific quality requirements of the pharmaceuticals and facilitate their storage, transportation and medical use.

發運中藥材必須有包裝。在每件包裝上，必須注明品名、產地、日期、調出單位，並附有質量合格的標志。

Traditional Chinese medicines must be packaged before transportation. On each package, the name of the product, its place of origin, the date and the consignor must be indicated and a sign for compliance with the quality standards must be marked.

第五十四條   藥品包裝必須按照規定印有或者貼有標簽並附有說明書。

Article 54 Packages of drugs shall be labeled and instructions attached as required.

標簽或者說明書上必須注明藥品的通用名稱、成份、規格、生產企業、批準文號、產品批號、生產日期、有效期、適應症或者功能主治、用法、用量、禁忌、不良反應和注意事項。

The label or directions must indicate the generic name of the medicine, ingredients, specifications, the producer, approval number, batch number of the product, production date, expiry date, indications or functions, directions for use, dosage, contraindications, adverse reactions and precautions.

麻醉藥品、精神藥品、醫療用毒性藥品、放射性藥品、外用藥品和非處方藥的標簽，必須印有規定的標志。

The labels of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use only and non-prescription drugs must bear the prescribed mark.

第七章 藥品價格和廣告的管理

Chapter 7 Drug Pricing and Advertising Management

第五十五條   依法實行市場調節價的藥品，藥品的生產企業、經營企業和醫療機構應當按照公平、合理和誠實信用、質價相符的原則制定價格，為用藥者提供價格合理的藥品。

Article 55. With regard to the drugs with market regulated prices, the drug-producing enterprises, drug-trading enterprises and medical organisations shall set the drug prices in accordance with the principles of being fair, reasonable, honest and trustworthy, and of matching the price with the quality so as to provide drug-users with reasonably priced drugs.

藥品的生產企業、經營企業和醫療機構應當遵守國務院價格主管部門關於藥價管理的規定，制定和標明藥品零售價格，禁止暴利和損害用藥者利益的價格欺詐行為。

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.

第五十六條   藥品的生產企業、經營企業、醫療機構應當依法向政府價格主管部門提供其藥品的實際購銷價格和購銷數量等資料。

Article 56. Drug-producing enterprises, drug-trading enterprises and medical organisations shall provide the responsible government department of price control with information concerning the actual purchase or sale prices of drugs and the quantities of purchases and sales.

第五十七條   醫療機構應當向患者提供所用藥品的價格清單；醫療保險定點醫療機構還應當按照規定的辦法如實公布其常用藥品的價格，加強合理用藥的管理。具體辦法由國務院衛生行政部門規定。

Article 57. Medical organisations shall provide patients with detailed price lists of the drugs the patients are prescribed; designated medical organisations covered by medical insurance shall also publish the prices of the frequently used drugs in a way stipulated by regulations, and shall strengthen the administration of drug use in a reasonable way. The specific measures in this regard shall be formulated by the health administration department under the State Council.

第五十八條   禁止藥品的生產企業、經營企業和醫療機構在藥品購銷中帳外暗中給予、收受回扣或者其他利益。

Article 58. Drug-producing enterprises, drug-trading enterprises and medical organisations are prohibited from giving or accepting commissions or other benefits when purchasing or selling drugs.

禁止藥品的生產企業、經營企業或者其代理人以任何名義給予使用其藥品的醫療機構的負責人、藥品采購人員、醫師等有關人員以財物或者其他利益。禁止醫療機構的負責人、藥品采購人員、醫師等有關人員以任何名義收受藥品的生產企業、經營企業或者其代理人給予的財物或者其他利益。

Pharmaceutical producing enterprises, trading enterprises or their agents 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. Leading members, drug purchasers, physicians, or other related persons of medical institutions are prohibited from accepting, in any name, money or things of value or other benefits offered by drug-producing enterprises, drug- trading enterprises or their agents.

第五十九條   藥品廣告須經企業所在地省、自治區、直轄市人民政府藥品監督管理部門批準，並發給藥品廣告批準文號；未取得藥品廣告批準文號的，不得發布。

Article 59. Drug advertisements must be approved by the drug control and administrative department of the people's government of a province, autonomous region or centrally administered municipality and an approval number for a drug advertisement must then be obtained. Where an approval number for a drug advertisement is not obtained, the advertisement must not be made public.

處方藥可以在國務院衛生行政部門和國務院藥品監督管理部門共同指定的醫學、藥學專業刊物上介紹，但不得在大眾傳播媒介發布廣告或者以其他方式進行以公眾為對象的廣告宣傳。

Prescription pharmaceuticals may be introduced in the medical or pharmaceutical journals jointly designated by the administrative department of health of the State Council and the drug regulatory department of the State Council, provided that they are not advertised in mass media or publicized to the public in any other form.

第六十條   藥品廣告的內容必須真實、合法，以國務院藥品監督管理部門批準的說明書為準，不得含有虛假的內容。

Article 60. The contents of a drug advertisement must be authentic and legal, based on the instructions for use approved by the drug control and administrative department of the State Council. False contents must not be included.

藥品廣告不得含有不科學的表示功效的斷言或者保證；不得利用國家機關、醫藥科研單位、學術機構或者專家、學者、醫師、患者的名義和形象作證明。

Drug advertisements shall not contain unscientific assertions or assurances in terms of effectiveness; and shall not use the names and images of government departments, pharmaceutical research units, academic institutions, experts, scholars, physicians and patients as supporting evidence.

非藥品廣告不得有涉及藥品的宣傳。

Non- drug advertisements must not include drug-related publicity.

第六十一條   省、自治區、直轄市人民政府藥品監督管理部門應當對其批準的藥品廣告進行檢查，對於違反本法和《中華人民共和國廣告法》的廣告，應當向廣告監督管理機關通報並提出處理建議，廣告監督管理機關應當依法作出處理。

Article 61. The drug control and administrative department of the people's government of a province, autonomous region or centrally administered municipality shall examine the drug advertisements to be approved. Where an advertisement violates this Law and the Law of Advertising of the People's Republic of China, it shall be reported to the authorities responsible for the supervision and control of advertising and suggestions to handle the matter shall be made; the authorities responsible for the supervision and control of advertising shall deal with the matter in accordance with the law.

第六十二條   藥品價格和廣告，本法未規定的，適用《中華人民共和國價格法》、《中華人民共和國廣告法》的規定。

Article 62. With regard to matters in relation to prices or advertisements of drugs that have not been stipulated in this Law, the Price Law of the People's Republic of China and the Law of Advertising of the People's Republic of China shall apply.

第八章 藥品監督

Chapter 8 Drug Supervision

第六十三條   藥品監督管理部門有權按照法律、行政法規的規定對報經其審批的藥品研制和藥品的生產、經營以及醫療機構使用藥品的事項進行監督檢查，有關單位和個人不得拒絕和隱瞞。

Article 63. The drug control and administrative departments have the right to conduct supervision and examination, in accordance with the provisions of the law and administrative regulations, in respect to the research on drugs and drug production and business operations submitted for approval, as well as issues regarding the use of drugs by medical organisations. The relevant units or individuals must not refuse to cooperate, or conceal anything.

藥品監督管理部門進行監督檢查時，必須出示證明文件，對監督檢查中知悉的被檢查人的技術秘密和業務秘密應當保密。

When conducting supervision and inspection, the drug control and administrative departments must produce identification and shall keep confidential the technical and business secrets of the persons under inspection coming to their knowledge in the course of supervision and inspection.

第六十四條   藥品監督管理部門根據監督檢查的需要，可以對藥品質量進行抽查檢驗。抽查檢驗應當按照規定抽樣，並不得收取任何費用。所需費用按照國務院規定列支。

Article 64. If necessary, the drug control and administrative department may carry out random testing of the quality of drugs. Sampling for random sampling inspection shall be carried out pursuant to the provisions, and no fees shall be collected. The cost shall be listed and paid in accordance with the regulations of the State Council.

藥品監督管理部門對有證據證明可能危害人體健康的藥品及其有關材料可以采取查封、扣押的行政強制措施，並在七日內作出行政處理決定；藥品需要檢驗的，必須自檢驗報告書發出之日起十五日內作出行政處理決定。

Pharmaceutical supervisory and administrative departments may take administrative coercive measures including sequestration and attachment against pharmaceuticals and related materials which have been proven to be potentially harmful to human health, and shall make decisions regarding the handling of the cases within seven days. For pharmaceuticals which need to be tested, decisions regarding the handling of the cases shall be made within 15 days from the date of issue of the testing reports.

第六十五條   國務院和省、自治區、直轄市人民政府的藥品監督管理部門應當定期公告藥品質量抽查檢驗的結果；公告不當的，必須在原公告範圍內予以更正。

Article 65. The drug control and administrative department of the people's government of a province, autonomous region or centrally administered municipality shall produce a public notice with regard to the results of any random tests of drug quality at regular intervals. Where the public notice is not properly produced, corrections must be made within the scope of the original public notice.

第六十六條   當事人對藥品檢驗機構的檢驗結果有異議的，可以自收到藥品檢驗結果之日起七日內向原藥品檢驗機構或者上一級藥品監督管理部門設置或者確定的藥品檢驗機構申請複驗，也可以直接向國務院藥品監督管理部門設置或者確定的藥品檢驗機構申請複驗。受理複驗的藥品檢驗機構必須在國務院藥品監督管理部門規定的時間內作出複驗結論。

Article 66. Where the parties concerned disagree with the results of a test conducted by the drug testing authorities, within seven (7) days of the receipt of the result of the drug test the parties concerned may apply for a review to the original drug testing authorities or the drug testing authorities established or designated by the drug control and administrative departments at a higher level, or apply for a review directly to the drug testing authorities established or designated by the drug control and administrative department of the State Council. The inspection institution which accepts the re-inspection shall conclude the re-inspection within the time limit prescribed by the pharmaceutical supervisory and administrative department under the State Council.

第六十七條   藥品監督管理部門應當按照規定，依據《藥品生產質量管理規範》、《藥品經營質量管理規範》，對經其認證合格的藥品生產企業、藥品經營企業進行認證後的跟蹤檢查。

Article 67. On the basis of the Standards for Quality Control of Drug Production and the Standards for Quality Control of Drug-trading, the drug control and administrative departments shall conduct follow-up tests of the drug-producing enterprises and drug-trading enterprises after they have been authenticated by the departments.

第六十八條   地方人民政府和藥品監督管理部門不得以要求實施藥品檢驗、審批等手段限制或者排斥非本地區藥品生產企業依照本法規定生產的藥品進入本地區。

Article 68. The drug control and administrative department of a local people's government must not, by way of requiring a drug test or examination and approval etc., restrict or exclude any drugs produced in accordance with the provisions of this Law from being introduced into a local region by drug-producing enterprises which do not belong to the region.

第六十九條   藥品監督管理部門及其設置的藥品檢驗機構和確定的專業從事藥品檢驗的機構不得參與藥品生產經營活動，不得以其名義推薦或者監制、監銷藥品。

Article 69. Drug control and administrative departments and the drug-testing authorities set up by these departments, as well as designated organisations engaging in professional drug testing must not participate in drug production or drug-trading activities and must not recommend, or supervise the production or sale of drugs in their names.

藥品監督管理部門及其設置的藥品檢驗機構和確定的專業從事藥品檢驗的機構的工作人員不得參與藥品生產經營活動。

The staff of drug control and administrative departments and the drug-testing authorities set up by these departments, as well as the designated authorities engaging in drug testing must not participate in drug production and operations.

第七十條   國家實行藥品不良反應報告制度。藥品生產企業、藥品經營企業和醫療機構必須經常考察本單位所生產、經營、使用的藥品質量、療效和反應。發現可能與用藥有關的嚴重不良反應，必須及時向當地省、自治區、直轄市人民政府藥品監督管理部門和衛生行政部門報告。具體辦法由國務院藥品監督管理部門會同國務院衛生行政部門制定。

Article 70 The state adopts the pharmaceutical side effect reporting system. Drug manufacturers, drug distributors and medical institutions shall make constant investigations into quality, therapeutic efficacy and reactions of the drugs produced, distributed and used thereby. 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. Specific measures therefor shall be formulated by the drug regulatory department under the State Council in concert with the administrative department for health under the State Council.

對已確認發生嚴重不良反應的藥品，國務院或者省、自治區、直轄市人民政府的藥品監督管理部門可以采取停止生產、銷售、使用的緊急控制措施，並應當在五日內組織鑒定，自鑒定結論作出之日起十五日內依法作出行政處理決定。

. Where there are drugs which have been confirmed to have serious side-effects, the drug control and administrative department of the State Council or the drug control and administrative department of the people's government of a province, autonomous region or centrally administered municipality may adopt emergency control measures to stop the production, sale and use of the drugs. An evaluation must be organised within five (5) days and an administrative handling decision must be made within 15 days of the conclusion of the evaluation.

第七十一條   藥品生產企業、藥品經營企業和醫療機構的藥品檢驗機構或者人員，應當接受當地藥品監督管理部門設置的藥品檢驗機構的業務指導。

Article 71. Drug-testing organisations of drug-producing enterprises, drug-trading enterprises and medical organisations and their staff shall receive professional guidance from the drug-testing authorities set up by the local drug control and administrative departments.

第九章 法律責任

Chapter 9 Legal Liabilities

第七十二條   未取得《藥品生產許可證》、《藥品經營許可證》或者《醫療機構制劑許可證》生產藥品、經營藥品的，依法予以取締，沒收違法生產、銷售的藥品和違法所得，並處違法生產、銷售的藥品（包括已售出的和未售出的藥品，下同）貨值金額二倍以上五倍以下的罰款；構成犯罪的，依法追究刑事責任。

Article 72. Production or trading of drugs without a Drug Production Licence, Drug-trading Licence or Dispensing Licence must be banned in accordance with the law. Drugs produced or sold in violation of the law and any illegal earnings must be confiscated. A fine of between two (2) to five (5) times the value of the illegally produced or sold drugs (including sold or unsold drugs) shall be imposed. Where a crime is constituted, criminal liability shall be pursued.

第七十三條   生產、銷售假藥的，沒收違法生產、銷售的藥品和違法所得，並處違法生產、銷售藥品貨值金額二倍以上五倍以下的罰款；有藥品批準證明文件的予以撤銷，並責令停產、停業整頓；情節嚴重的，吊銷《藥品生產許可證》、《藥品經營許可證》或者《醫療機構制劑許可證》；構成犯罪的，依法追究刑事責任。

Article 73. Where spurious drugs are produced or sold, the illegally produced or sold drugs and the illegal earnings shall be confiscated. A fine of between two (2) to five (5) times the value of the illegally produced or sold spurious drugs shall be imposed. Where a drug approval certificate has been issued, the certificate shall be cancelled, and the parties involved shall be ordered to stop production or stop operations for rectification. Where the situation is serious, the Drug Production Licence, Drug-trading Licence or Dispensing Licence may be revoked. Where a crime is constituted, criminal liability shall be pursued.

第七十四條   生產、銷售劣藥的，沒收違法生產、銷售的藥品和違法所得，並處違法生產、銷售藥品貨值金額一倍以上三倍以下的罰款；情節嚴重的，責令停產、停業整頓或者撤銷藥品批準證明文件、吊銷《藥品生產許可證》、《藥品經營許可證》或者《醫療機構制劑許可證》；構成犯罪的，依法追究刑事責任。

Article 74. Where inferior drugs are produced or sold, the illegally produced or sold drugs and the illegal earnings shall be confiscated. A fine of between two (2) to three (3) times the value of the illegally produced or sold inferior drugs shall be imposed. Where a drug approval certificate is issued, the certificate shall be cancelled, and the parties involved shall be ordered to stop production or stop operations for rectification. Where the situation is serious, the Drug Production Licence, Drug-trading Licence or Dispensing Licence may be revoked. Where a crime is constituted, criminal liability shall be pursued.

第七十五條   從事生產、銷售假藥及生產、銷售劣藥情節嚴重的企業或者其他單位，其直接負責的主管人員和其他直接責任人員十年內不得從事藥品生產、經營活動。

Article 75. Where there are serious cases of enterprises or other units engaging in the production and sale of spurious drugs or in the production and sale of inferior drugs, the directly responsible personnel and other directly responsible personnel must not engage in drug producing or drug trading activities within the next ten years.

對生產者專門用於生產假藥、劣藥的原輔材料、包裝材料、生產設備，予以沒收。

The crude materials, accessories, packaging materials and manufacturing equipment used by manufacturers to produce counterfeit or substandard drugs shall be confiscated.

第七十六條   知道或者應當知道屬於假劣藥品而為其提供運輸、保管、倉儲等便利條件的，沒收全部運輸、保管、倉儲的收入，並處違法收入百分之五十以上三倍以下的罰款；構成犯罪的，依法追究刑事責任。

Article 76. Where any parties who have the knowledge, or should have the knowledge, that drugs are spurious or inferior, still provide the convenience of transport, preservation or storage, the earnings from the transport, preservation and storage of the drugs shall all be confiscated. A fine of between fifty per cent and three (3) times the illegal earnings shall be imposed. Where a crime is constituted, criminal liability shall be pursued.

第七十七條   對假藥、劣藥的處罰通知，必須載明藥品檢驗機構的質量檢驗結果；但是，本法第四十八條第三款第（一）、（二）、（五）、（六）項和第四十九條第三款規定的情形除外。

Article 77. The penalty notice for spurious or inferior drugs shall bear the results of the quality examination of the drug-testing authorities. However, the circumstances listed in Items 1, 2, 5 and 6 in paragraph 3 of Article 48 and the provisions in paragraph 3 of Article 49 of this Law are excepted.

第七十八條   藥品的生產企業、經營企業、藥物非臨床安全性評價研究機構、藥物臨床試驗機構未按照規定實施《藥品生產質量管理規範》、《藥品經營質量管理規範》、藥物非臨床研究質量管理規範、藥物臨床試驗質量管理規範的，給予警告，責令限期改正；逾期不改正的，責令停產、停業整頓，並處五千元以上二萬元以下的罰款；情節嚴重的，吊銷《藥品生產許可證》、《藥品經營許可證》和藥物臨床試驗機構的資格。

Article 78. Where drug-producing enterprises, drug- trading enterprises, research institutions of non-clinical drug safetyappraisal, or clinical drug testing organisations fail to implement the Standards for Quality Control of Drug Production, Standards for Quality Control of Drug-trading, quality control standards for non-clinical drug research, or quality control standards for clinical drug testing, warnings and orders shall be issued for corrective measures to be taken within a time limit. Where no corrective measures have been taken when the time limit has passed, orders must be issued to stop production or operations for rectification, and a fine of between 5,000 yuan and 20,000 yuan shall be imposed. Where the situation is serious, the Drug Production Licence, Drug-trading Licence or qualifications as a clinical drug-testing body shall be revoked.

第七十九條   藥品的生產企業、經營企業或者醫療機構違反本法第三十四條的規定，從無《藥品生產許可證》、《藥品經營許可證》的企業購進藥品的，責令改正，沒收違法購進的藥品，並處違法購進藥品貨值金額二倍以上五倍以下的罰款；有違法所得的，沒收違法所得；情節嚴重的，吊銷《藥品生產許可證》、《藥品經營許可證》或者醫療機構執業許可證書。

Article 79. Where drug-producing enterprises, drug- trading enterprises or medical organisation, in violation of the provisions in Article 34 of this Law, purchase drugs from enterprises which do not have a Drug Production Licence or Drug-trading Licence, they shall be ordered to make corrections. Illegally purchased drugs shall be confiscated. A fine of between two (2) times and five (5) times the value of the illegally purchased drugs shall be imposed. Where there are illegal earnings, they shall be confiscated. Where the situation is serious, Drug Production Licences, Drug-trading Licences or the operation licences of medical organisations shall be revoked.

第八十條   進口已獲得藥品進口注冊證書的藥品，未按照本法規定向允許藥品進口的口岸所在地的藥品監督管理部門登記備案的，給予警告，責令限期改正；逾期不改正的，撤銷進口藥品注冊證書。

Article 80. Where the import of drugs which have been granted a registration certificate for drug import has not been registered for the record, in accordance with the provisions of this Law, with the drug control and administrative departments at the place where the port permitted to import the drugs is located, warnings shall be issued. The parties involved shall be ordered to make corrections within a time limit. Where no correction is made when the time limit has passed, the registration certificate for the drug import shall be revoked.

第八十一條   偽造、變造、買賣、出租、出借許可證或者藥品批準證明文件的，沒收違法所得，並處違法所得一倍以上三倍以下的罰款；沒有違法所得的，處二萬元以上十萬元以下的罰款；情節嚴重的，並吊銷賣方、出租方、出借方的《藥品生產許可證》、《藥品經營許可證》、《醫療機構制劑許可證》或者撤銷藥品批準證明文件；構成犯罪的，依法追究刑事責任。

Article 81. Where licences or drug approval documents are forged, altered, purchased or sold, leased or lent, the illegal earnings shall be confiscated. A fine of between two (2) times and three (3) times the illegal earnings shall be imposed. Where there are no illegal earnings, a fine of between 20,000 yuan and 100,000 yuan shall be imposed. Where the situation is serious, the Drug Production Licences, Drug-trading licences, or Dispensing Licences shall be revoked, or drug approval documents shall be cancelled. Where a crime is constituted, criminal liability shall be pursued.

第八十二條   違反本法規定，提供虛假的證明、文件資料、樣品或者采取其他欺騙手段取得《藥品生產許可證》、《藥品經營許可證》、《醫療機構制劑許可證》或者藥品批準證明文件的，吊銷《藥品生產許可證》、《藥品經營許可證》、《醫療機構制劑許可證》或者撤銷藥品批準證明文件，五年內不受理其申請，並處一萬元以上三萬元以下的罰款。

Article 82. Where Drug Production Licences, Drug-trading Licences, Dispensing Licences, or drug approval documents are obtained by way of providing false certificates, documents and materials or samples or by other deceptive means, the Drug Production Licences, Drug-trading Licences, Dispensing Licences shall be revoked, or drug approval documents shall be cancelled. No re-applications shall be accepted within the next five (5) years. A fine of between 10,000 yuan and 30,000 yuan shall be imposed.

第八十三條   醫療機構將其配制的制劑在市場銷售的，責令改正，沒收違法銷售的制劑，並處違法銷售制劑貨值金額一倍以上三倍以下的罰款；有違法所得的，沒收違法所得。

Article 83. Where a medical organisation sells in the market medicine made up by itself, the medical organisation shall be ordered to rectify the situation. Medicine sold illegally shall be confiscated. A fine between of two (2) times and three (3) times the value of the illegally sold medicine shall be imposed. Where there are illegal earnings, the illegal earnings shall be confiscated.

第八十四條   藥品經營企業違反本法第十八條、第十九條規定的，責令改正，給予警告；情節嚴重的，吊銷《藥品經營許可證》。

Article 84. Where drug-trading enterprises violate the provisions in Article 18 and Article 19 of this Law, they shall be ordered to rectify the situation. Where the situation is serious, Drug-trading Licences shall be revoked.

第八十五條   藥品標識不符合本法第五十四條規定的，除依法應當按照假藥、劣藥論處的外，責令改正，給予警告；情節嚴重的，撤銷該藥品的批準證明文件。

Article 85. Where drug labels do not comply with the provisions in Article 54 of this Law, except where punishment is required to be imposed for spurious or inferior drugs in accordance with law, an order shall be issued to rectify the situation and a warning shall be issued. Where the situation is serious, the approval documents of the said drug shall be cancelled.

第八十六條   藥品檢驗機構出具虛假檢驗報告，構成犯罪的，依法追究刑事責任；不構成犯罪的，責令改正，給予警告，對單位並處三萬元以上五萬元以下的罰款；對直接負責的主管人員和其他直接責任人員依法給予降級、撤職、開除的處分，並處三萬元以下的罰款；有違法所得的，沒收違法所得；情節嚴重的，撤銷其檢驗資格。藥品檢驗機構出具的檢驗結果不實，造成損失的，應當承擔相應的賠償責任。

Article 86. Where a drug-testing body issues a false examination report, thus constituting a crime, criminal liability shall be pursued. Where no crime is constituted, the drug-testing body shall be ordered to rectify the situation and a warning shall be issued. A fine of between 30,000 yuan and 50,000 yuan shall be imposed. Disciplinary actions of demotion, dismissal or expulsion shall be imposed upon the directly responsible leading personnel and other directly responsible personnel. A fine of up to 30,000 yuan shall be imposed. Where there are illegal earnings, the illegal earnings shall be confiscated. Where the situation is serious, the qualifications for drug testing shall be cancelled. If an inspection institution produces false inspection reports and causes serious consequences, it shall bear corresponding liabilities for compensation.

第八十七條   本法第七十二條至第八十六條規定的行政處罰，由縣級以上藥品監督管理部門按照國務院藥品監督管理部門規定的職責分工決定；吊銷《藥品生產許可證》、《藥品經營許可證》、《醫療機構制劑許可證》、醫療機構執業許可證書或者撤銷藥品批準證明文件的，由原發證、批準的部門決定。

Article 87. The administrative penalties in the provisions from Article 72 to Article 86 of this Law shall be determined by the drug control and administrative departments at county level or above in accordance with the duties stipulated by the drug control and administrative department of the State Council. Where Drug Production Licences, Drug-trading Licences, Dispensing Licences, Business Licences of Medical Bodies, or drug approval documents are revoked, the decisions shall be made by the original departments which issued the licences or gave the approval.

第八十八條   違反本法第五十五條、第五十六條關於藥品價格管理的規定的，依照《中華人民共和國價格法》的規定處罰。

Article 88. Where there are violations of the provisions on the management of drug prices in Articles 55 and 56 of this Law, penalties shall be imposed in accordance with the Price Law of the People's Republic of China.

第八十九條   藥品的生產企業、經營企業、醫療機構在藥品購銷中暗中給予、收受回扣或者其他利益的，藥品的生產企業、經營企業或者其代理人給予使用其藥品的醫療機構的負責人、藥品采購人員、醫師等有關人員以財物或者其他利益的，由工商行政管理部門處一萬元以上二十萬元以下的罰款，有違法所得的，予以沒收；情節嚴重的，由工商行政管理部門吊銷藥品生產企業、藥品經營企業的營業執照，並通知藥品監督管理部門，由藥品監督管理部門吊銷其《藥品生產許可證》、《藥品經營許可證》；構成犯罪的，依法追究刑事責任。

Article 89. Where in the purchase or sale of drugs, drug-producing enterprises, drug- trading enterprises, or medical organisations offer or accept commissions or other benefits in secret, or drug-producing enterprises, drug- trading enterprises or their agents offer money, goods or other benefits to the responsible persons of medical organisations, drug purchasing personnel, doctors or other related personnel who use their drugs, the administrative authorities responsible for industry and commerce shall impose a fine of between 10,000 yuan and 200,000 yuan. Where there are illegal earnings, the illegal earnings shall be confiscated. Where the situation is serious, the administrative authorities responsible for industry and commerce shall revoke the business licences of the drug-producing and drug-trading enterprises, and notify the drug control and administrative department to revoke the Drug Production Licences and Drug-trading Licences. Where a crime is constituted, criminal liability shall be pursued.

第九十條   藥品的生產企業、經營企業的負責人、采購人員等有關人員在藥品購銷中收受其他生產企業、經營企業或者其代理人給予的財物或者其他利益的，依法給予處分，沒收違法所得；構成犯罪的，依法追究刑事責任。

Article 90. Where in the purchase or sale of drugs, the responsible personnel or drug purchasing personnel of drug-producing or drug- trading enterprises receive money, goods or other benefits offered by other drug- producing enterprises, drug- trading enterprises or their agents, penalties shall be imposed in accordance with the law and illegal earnings shall be confiscated. Where a crime is constituted, criminal liability shall be pursued.

醫療機構的負責人、藥品采購人員、醫師等有關人員收受藥品生產企業、藥品經營企業或者其代理人給予的財物或者其他利益的，由衛生行政部門或者本單位給予處分，沒收違法所得；對違法行為情節嚴重的執業醫師，由衛生行政部門吊銷其執業證書；構成犯罪的，依法追究刑事責任。

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 disciplined by the administrative departments of health or the work units to which they belong, and the unlawful gains shall be confiscated.

第九十一條   違反本法有關藥品廣告的管理規定的，依照《中華人民共和國廣告法》的規定處罰，並由發給廣告批準文號的藥品監督管理部門撤銷廣告批準文號，一年內不受理該品種的廣告審批申請；構成犯罪的，依法追究刑事責任。

Article 91 Where the provisions of this Law on the control of drug advertising are violated, penalties shall be imposed in accordance with the provisions in the Law of Advertising of the People's Republic of China; and the drug control and administrative departments which issued approval numbers for advertisements shall cancel the approval numbers of the advertisements. A re-application for an approval number for advertising of the said drugs shall not be accepted within one (1) year. Where a crime is constituted, criminal liability shall be pursued.

藥品監督管理部門對藥品廣告不依法履行審查職責，批準發布的廣告有虛假或者其他違反法律、行政法規的內容的，對直接負責的主管人員和其他直接責任人員依法給予行政處分；構成犯罪的，依法追究刑事責任。

Where a drug control and administrative department does not fulfil its duties to examine drug advertisements, and where the approved advertisements contain false or other contents that violate the law or administrative regulations, the directly responsible leading personnel and other directly responsible personnel shall have administrative sanctions imposed in accordance with the law. Where a crime is constituted, criminal liability shall be pursued.

第九十二條   藥品的生產企業、經營企業、醫療機構違反本法規定，給藥品使用者造成損害的，依法承擔賠償責任。

Article 92. Where drug-producing enterprises, drug- trading enterprises or medical organisations violate the provisions of this Law and cause damage to drug users, they shall assume liability for compensation.

第九十三條   藥品監督管理部門違反本法規定，有下列行為之一的，由其上級主管機關或者監察機關責令收回違法發給的證書、撤銷藥品批準證明文件，對直接負責的主管人員和其他直接責任人員依法給予行政處分；構成犯罪的，依法追究刑事責任:

Article 93 Any drug regulatory department that violates the provisions of the Law and commits any of the following acts shall be ordered by the competent authority at the next higher level or the supervisory body to withdraw the certificates unlawfully issued or to withdraw the drug approval documents, and administrative sanctions shall be given to the persons directly in charge and the other persons directly liable in accordance with the law. If a crime is constituted, criminal liabilities shall be prosecuted in accordance with the law:

（一）對不符合《藥品生產質量管理規範》、《藥品經營質量管理規範》的企業發給符合有關規範的認證證書的，或者對取得認證證書的企業未按照規定履行跟蹤檢查的職責，對不符合認證條件的企業未依法責令其改正或者撤銷其認證證書的；

1. issuing the certificates proving the compliance with the Good Manufacturing Practice for Drugs or the Good Distribution Practice for Drugs to the enterprises that do not meet the corresponding requirements, failing to perform, as required, the duty of follow-up inspections in respect of the enterprises that have obtained the certificates, or failing to order, in accordance with the law, the enterprises not meeting the requirements to make corrections or failing to revoke their certificates; or

（二）對不符合法定條件的單位發給《藥品生產許可證》、《藥品經營許可證》或者《醫療機構制劑許可證》的；

(II) issuing a Drug Manufacturing Certificate, Drug Distribution Certificate or Pharmaceutical Preparation Certificate for Medical Institution to the entities that do not meet the statutory requirements;

（三）對不符合進口條件的藥品發給進口藥品注冊證書的；

(III) issue a registration certificate of import to a drug that does not meet the requirements for import;

（四）對不具備臨床試驗條件或者生產條件而批準進行臨床試驗、發給新藥證書、發給藥品批準文號的。

(IV) granting approval for conducting a clinical trial, issuing a new drug certificate or a drug approval number, where the requirements for clinical trial or production are not met.

第九十四條   藥品監督管理部門或者其設置的藥品檢驗機構或者其確定的專業從事藥品檢驗的機構參與藥品生產經營活動的，由其上級機關或者監察機關責令改正，有違法收入的予以沒收；情節嚴重的，對直接負責的主管人員和其他直接責任人員依法給予行政處分。

Article 94. Where a drug control and administrative department, a drug-testing institution set up by this department, or an institution specialising in drug testing designated by this department participates in drug production and operations, it shall be ordered by the higher authorities or supervising authorities to rectify the situation. Where there are illegal earnings, they shall be confiscated. Where the situation is serious, the directly responsible leading personnel and other directly responsible personnel shall have administrative sanctions imposed in accordance with the law.

藥品監督管理部門或者其設置的藥品檢驗機構或者其確定的專業從事藥品檢驗的機構的工作人員參與藥品生產經營活動的，依法給予行政處分。

If a staff member in a pharmaceutical supervisory and administrative department, or in an inspection institution it has established, or in an institution 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.

第九十五條   藥品監督管理部門或者其設置、確定的藥品檢驗機構在藥品監督檢驗中違法收取檢驗費用的，由政府有關部門責令退還，對直接負責的主管人員和其他直接責任人員依法給予行政處分。對違法收取檢驗費用情節嚴重的藥品檢驗機構，撤銷其檢驗資格。

Article 95. Where in the supervision and testing of drugs, a drug control and administrative department or a drug-testing institution set up or designated by this department charges fees for the testing, in violation of the law, the relevant government department shall be ordered to refund the fees. The directly responsible leading personnel and other directly responsible personnel shall have administrative sanctions imposed in accordance with the law. Where a drug testing institution has seriously violated the law by charging testing fees, its testing qualification shall be revoked.

第九十六條   藥品監督管理部門應當依法履行監督檢查職責，監督已取得《藥品生產許可證》、《藥品經營許可證》的企業依照本法規定從事藥品生產、經營活動。

Article 96. The drug control and administrative departments shall fulfil their duties of supervision and examination in accordance with the law and shall supervise the enterprises which have obtained Drug Production Licences or Drug-trading Licences as they engage in drug production and trade in accordance with the provisions of this Law.

已取得《藥品生產許可證》、《藥品經營許可證》的企業生產、銷售假藥、劣藥的，除依法追究該企業的法律責任外，對有失職、渎職行為的藥品監督管理部門直接負責的主管人員和其他直接責任人員依法給予行政處分；構成犯罪的，依法追究刑事責任。

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 departments who have neglected or have been derelict in their duties shall be subject to administrative sanctions. If a crime is constituted, they shall be investigated for criminal liabilities according to laws and regulations.

第九十七條   藥品監督管理部門對下級藥品監督管理部門違反本法的行政行為，責令限期改正；逾期不改正的，有權予以改變或者撤銷。

Article 97. Where a lower drug control and administrative department is responsible for administrative conduct in violation of this Law, the drug control and administrative department shall order it to rectify the situation within a time limit. Where no actions are taken within the time limit, the drug control and administrative department has the right to make alterations or cancellations.

第九十八條   藥品監督管理人員濫用職權、徇私舞弊、玩忽職守，構成犯罪的，依法追究刑事責任；尚不構成犯罪的，依法給予行政處分。

Article 98. Where the personnel of a drug control and administration department abuse their power, practise favouritism or neglect their duties and thus commit crimes, criminal liability shall be pursued. Where no crime is constituted, administrative penalties shall be imposed.

第九十九條   本章規定的貨值金額以違法生產、銷售藥品的標價計算；沒有標價的，按照同類藥品的市場價格計算。

Article 99. In this chapter, the value of the goods is calculated with reference to the marked prices of the illegally produced or sold drugs. Where there are no marked prices, the calculations are made with reference to the market prices of drugs of the same type.

第十章 附則

Chapter 10 Supplementary Provisions

第一百條   本法下列用語的含義是:

Article 100 For the purpose of this Law, the definitions of the following terms are:

藥品，是指用於預防、治療、診斷人的疾病，有目的地調節人的生理機能並規定有適應症或者功能主治、用法和用量的物質，包括中藥材、中藥飲片、中成藥、化學原料藥及其制劑、抗生素、生化藥品、放射性藥品、血清、疫苗、血液制品和診斷藥品等。

Drugs refer to substances which are used in the prevention, treatment and diagnosis of human diseases, and intended to regulate human physiological functions, for which indications or major functions, usage and dosage are specified, including traditional Chinese medicinal materials, traditional Chinese medicine decoction pieces, traditional Chinese patent medicines, chemical raw material medicines and their preparations, antibiotics, biochemical drugs, radioactive drugs, serums, vaccines, blood products and diagnostic drugs.

輔料，是指生產藥品和調配處方時所用的賦形劑和附加劑。

Supplementary materials shall mean excipients and additives used for drug production and formulation.

藥品生產企業，是指生產藥品的專營企業或者兼營企業。

Pharmaceutical producing enterprise "means an enterprise exclusively or partly engaged in the production of pharmaceuticals.

藥品經營企業，是指經營藥品的專營企業或者兼營企業。

Pharmaceutical trading enterprise "means an enterprise exclusively or partly engaged in the trading of pharmaceuticals.

第一百零一條   中藥材的種植、采集和飼養的管理辦法，由國務院另行制定。

Article 101 The administrative measures for the cultivation and collection of raw materials for Chinese medicines or the raising of animals in relation to Chinese medicines shall be separately formulated by the State Council.

第一百零二條   國家對預防性生物制品的流通實行特殊管理。具體辦法由國務院制定。

Article 102 The State exercises special administration over the circulation of preventive biological products. Specific measures shall be formulated by the State Council.

第一百零三條   中國人民解放軍執行本法的具體辦法，由國務院、中央軍事委員會依據本法制定。

Article 103 Specific measures for implementation of this Law by the Chinese People's Liberation Army shall be formulated by the State Council and the Central Military Commission in accordance with this Law.

第一百零四條   本法自2001年12月1日起施行。

Article 104 This Law shall go into effect as of December 1, 2001.