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Order Of The President Of The People's Republic Of China No. 45
The Pharmaceutical Administration Law of the People's Republic of China, revised at the Twentieth Meeting of the Standing Committee of the Ninth National People's Congress on February 28,2000, is hereby promulgated and shall enter into force as of the date of December 1, 2001.
Jiang Zemin, President of the People's Republic of China
February 28,2001
Pharmaceutical Administration Law of the People's Republic of China
(Adopted at the Seventh Meeting of the Standing Committee of the Sixth National People's Congress on September 20, 1984, and revised at the Twentieth Meeting of the Ninth National People's Congress on February 28, 2001.)
| | 中華人民共和國主席令
（第四十五號）
《中華人民共和國藥品管理法》已由中華人民共和國第九屆全國人民代表大會常務委員會第二十次會議于２００１年２月２８日修訂通過，現將修訂後的《中華人民共和國藥品管理法》公布，自２００１年１２月１日起施行。
中華人民共和國主席 江澤民
２００１年２月２８日
中華人民共和國藥品管理法
（１９８４年９月２０日第五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）
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Contents
| | 目錄
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Chapter I General Provisions
| | 第一章 總則
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Chapter II Administration of Pharmaceutical Producing Enterprises
| | 第二章 藥品生產企業管理
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Chapter III Administration of Pharmaceutical Trading Enterprises
| | 第三章 藥品經營企業管理
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Chapter IV Administration of Pharmaceuticals at Medical Organizations
| | 第四章 醫療機構的藥劑管理
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Chapter V Pharmaceutical Administration
| | 第五章 藥品管理
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Chapter VI Administration of the Packaging of Pharmaceuticals
| | 第六章 藥品包裝的管理
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Chapter VII Administration of the Prices and Advertising of Pharmaceuticals
| | 第七章 藥品價格和廣告的管理
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Chapter VIII Supervision over Pharmaceuticals
| | 第八章 藥品監督
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Chapter IX Legal Responsibility
| | 第九章 法律責任
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Chapter X Supplementary Provisions
| | 第十章 附則
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Chapter I General Provisions
| | 第一章 總則
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Article 1 This law is formulated to enhance the supervision and control of pharmaceuticals, ensure their quality, guarantee safety in medication, and safeguard the health and legal rights and interests of the people.
| | 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。
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Article 2 The law shall be applicable to any units or individuals engaged in research, production, trade, use, supervision and management of pharmaceuticals within the territory of the People's Republic of China.
| | 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。
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Article 3 The State shall develop both modern and traditional medicines encourage their role in the prevention and treatment of diseases and in health care.
The State shall protect the resources of wild medicinal resources and encourage the domestic cultivation of Chinese traditional medicinal crops.
| | 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。
國家保護野生藥材資源，鼓勵培育中藥材。
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Article 4 The State shall encourage the research and production of new medicine and protect the legal rights and interests of its citizens, natural persons and other organizations in the research and development of new medicine.
| | 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。
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Article 5 The pharmaceuticals supervisory and administrative departments under the State Council shall be responsible for the supervision and control of pharmaceuticals throughout the country. Other relevant departments under the State Council shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions.
The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals within their administrative regions. Other relevant departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions.
The pharmaceutical supervisory and administrative departments under the State Council shall cooperate with the general administrative department of the economy under the State Council to carry out pharmaceutical development plans and industrial policies formulated by the State.
| | 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。
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。
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。
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Article 6 The pharmaceutical inspection institutions established or approved by the pharmaceutical supervisory and administrative departments shall be charged with the work of pharmaceutical examination and approval, as well as quality inspection, in accordance with laws and regulations.
| | 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。
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Chapter II Administration of Pharmaceutical Producing Enterprises
| | 第二章 藥品生產企業管理
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Article 7. The establishment of a pharmaceutical producing enterprise must be approved by and issued a Pharmaceutical Production License by the pharmaceutical supervisory and administrative department of the province, autonomous region, or municipality directly under the Central government in which the enterprise is located.The establishment shall be registered at the industry and commerce administrative department based on the Pharmaceutical Production License, without which no pharmaceuticals shall be produced.
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.
The approval of the establishment of pharmaceutical producing enterprises by the pharmaceutical supervisory and administrative departments shall be in conformity with Article 8 of this law, as well as the pharmaceutical development plan and the industrial policies formulated by the State to avoid the instance of a repeat establishment.
| | 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准並發給《藥品生產許可證》，憑《藥品生產許可證》到工商行政管理部門辦理登記注冊。無《藥品生產許可證》的，不得生產藥品。
《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。
藥品監督管理部門批准開辦藥品生產企業，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。
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Article 8. To establish a pharmaceutical producing enterprise, the following requirements must be met:
| | 第八條 開辦藥品生產企業，必須具備以下條件：
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(1) It shall be staffed with legally certified pharmaceutical technical personnel, engineering technical personnel, as well as corresponding skilled workers.
| | （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；
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(2) It shall have factory premises, facilities and a sanitary environment suitable for the medicines produced.
| | （二）具有與其藥品生產相適應的廠房、設施和衛生環境；
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(3) It shall have a unit or competent personnel capable of inspecting the quality of the medicines produced, as well as necessary instruments and equipment.
| | （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；
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(4) It shall have rules and regulations to ensure the quality of medicines.
| | （四）具有保證藥品質量的規章制度。
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Article 9 Pharmaceutical producing enterprises must organize production in accordance with the “Standards for Quality Control of Pharmaceutical Production” formulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law. Pharmaceutical supervisory and administrative departments shall confirm whether the pharmaceutical producing enterprises have met the requirements of the “Standards,” and shall issue certificates to those qualified ones.
The detailed implementation measures and implementation process of the “Standards for Quality Control of Pharmaceutical Production” shall be formulated by the pharmaceutical supervisory and administrative department under the State Council.
| | 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。
《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。
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Article 10 Except in the preparation of traditional 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. The changes of technological procedure made by the pharmaceutical producing enterprises which affect the quality of the pharmaceuticals shall be examined and approved by the original approval authorities.
The process for preparing traditional Chinese medicines into ready-to-use forms must conform to the national pharmaceutical standards, and in the absence of such standards, the process must conform to the processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central government. The processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central governments shall be placed on record at the pharmaceutical supervisory and administrative 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准和國務院藥品監督管理部門批准的生產工藝進行生產，生產記錄必須完整准確。藥品生產企業改變影響藥品質量的生產工藝的，必須報原批准部門審核批准。
中藥飲片必須按照國家藥品標准炮制；國家藥品標准沒有規定的，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。
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Article 11 The raw and supplementary materials used for the production of pharmaceuticals must conform to the requirements for medicinal use.
| | 第十一條 生產藥品所需的原料、輔料，必須符合藥用要求。
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Article 12 The pharmaceutical producing enterprises must conduct quality inspections on the pharmaceuticals they produce; products which do not meet national pharmaceutical standards or are not prepared in conformity with the processing standards stipulated by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government shall not leave the factory.
| | 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；不符合國家藥品標准或者不按照省、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。
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Article 13 Pharmaceutical producing enterprises can accept the authorization to produce pharmaceuticals after they obtain approval from the pharmaceutical supervisory and administrative department under the State Council or the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government authorized by the supervisory and administrative department of pharmaceuticals under the State Council.
| | 第十三條 經國務院藥品監督管理部門或者國務院藥品監督管理部門授權的省、自治區、直轄市人民政府藥品監督管理部門批准，藥品生產企業可以接受委托生產藥品。
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Chapter III Administration of Pharmaceutical Trading Enterprises
| | 第三章 藥品經營企業管理
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Article 14 The establishment of pharmaceutical wholesale enterprises must be sanctioned by the competent local authorities of the production and trade of pharmaceuticals of the provinces, autonomous regions or municipalities directly under the central government, which will issue a Pharmaceutical Trade License. The establishment of pharmaceutical retail enterprises must be sanctioned by local authorities for the supervision and control of pharmaceuticals at or above the county level, which will issue a Pharmaceutical Trade License, on the basis of which registration at the industry and commerce administrative departments shall be conducted. Without the Pharmaceutical Trade License, any enterprises shall not engage in the trade of pharmaceuticals.
A Pharmaceutical Trade License shall bear a scope of trade and a period of validity, and upon expiration a new license shall be issued after examination for its renewal.
The approval of the establishment of pharmaceutical trading enterprises by the pharmaceutical supervisory and administrative departments shall adhere to the principle of reasonable positioning and convenience for buying of pharmaceuticals, and in addition must conform to Article 15 of this Law.
| | 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准並發給《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准並發給《藥品經營許可證》，憑《藥品經營許可證》到工商行政管理部門辦理登記注冊。無《藥品經營許可證》的，不得經營藥品。
《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。
藥品監督管理部門批准開辦藥品經營企業，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。
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Article 15 To establish a pharmaceutical trading enterprise, the following requirements must be met
| | 第十五條 開辦藥品經營企業必須具備以下條件：
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1. It shall be staffed with legally certified pharmaceutical technical personnel.
| | （一）具有依法經過資格認定的藥學技術人員；
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2. It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades.
| | （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；
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3. It shall have a quality control organ or personnel 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；
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4. It shall have rules and regulations to ensure the quality of the pharmaceuticals in which it trades.
| | （四）具有保證所經營藥品質量的規章制度。
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Article 16 Pharmaceutical producing enterprises must trade in pharmaceuticals in accordance with the “Standards for Quality Control of Pharmaceutical Trading” stipulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law. Pharmaceutical supervisory and administrative departments shall certify whether pharmaceutical trading enterprises meet the requirements of the “Standards for Quality Control of Pharmaceutical Trading” in accordance with relevant regulations, and issue certifications to qualified enterprises.
Detailed implementation measures and procedures for the “Standards for Quality Control of Pharmaceutical Trading” shall be stipulated by the pharmaceutical supervisory and administrative departments under the State Council.
| | 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。
《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。
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Article 17. Pharmaceutical trading enterprises must formulate and implement check and approval rules for the purchase of pharmaceuticals, and check pharmaceutical certifications and other marks while purchasing pharmaceuticals. Pharmaceuticals that do not meet the required standards must not be purchased.
| | 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。
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Article 18. Pharmaceutical trading enterprises shall keep accurate and complete records of purchased pharmaceuticals. Purchasing records must bear information on the pharmaceutical product's generic names, types, specifications, batches, valid periods, producing enterprises, purchasing (selling) units, purchasing (selling) quantity, purchasing and selling price, purchasing (selling) date and other contents required by the pharmaceutical supervisory and administrative department under the State Council.
| | 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。
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Article 19 It is imperative for pharmaceutical trading enterprises, in the sale of pharmaceuticals, to be accurate and free of mistakes, and to provide correct directions for use, dosage and precautions. Prescriptions being dispensed must be checked. Pharmaceutical products listed in the prescription must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or re-signed by the doctors who wrote them.
When traditional Chinese medicinal materials are offered for sale by pharmaceutical trading enterprises, their origin must be indicated.
| | 第十九條 藥品經營企業銷售藥品必須准確無誤，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。
藥品經營企業銷售中藥材，必須標明產地。
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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 freezing, moisture, insects and rodents to ensure pharmaceutical quality.
An inspection system shall be carried out for pharmaceuticals entering or leaving a warehouse.
| | 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。
藥品入庫和出庫必須執行檢查制度。
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Article 21 Unless otherwise stipulated by the State, traditional Chinese medicinal materials may be marketed at urban or rural fairs.
Pharmaceuticals other than traditional Chinese medicinal materials may not be sold at urban or rural fairs, but those retail enterprises which have the Pharmaceutical Trade License may set up stalls at urban or rural fairs to sell pharmaceuticals other than traditional Chinese medicinal materials within prescribed areas. Detailed measures shall be stipulated by the State Council.
| | 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。
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。
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Chapter IV Administration of Pharmaceuticals at Medical Organizations
| | 第四章 醫療機構的藥劑管理
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Article 22 Medical organizations must be staffed with legally certified pharmaceutical technical personnel. Non-pharmaceutical technical personnel may not be directly engaged in the technical work of the pharmacy.
| | 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。
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Article 23 To make medicinal preparations, a medical organization must be examined and approved by the administrative departments of health of the provinces, autonomous regions, or municipalities directly under the central government where the organization is located , and approved and issued a Dispensing Permit for Medical Organizations by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions or municipalities directly under the central government. No medicinal preparations shall be made without a Dispensing Permit for Medical Organizations.
The Dispensing Permit for Medical Organizations shall bear a period of validity, and upon expiration a new license shall be issued after examination for its renewal.
| | 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准，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。
《醫療機構制劑許可證》應當標明有效期，到期重新審查發證。
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Article 24 Medical organizations that make medicinal preparations must have facilities, a managerial system, inspection instruments, and a sanitary environment to ensure quality.
| | 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。
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Article 25. The medicinal preparations made by medical organizations shall be of the kinds that supply the clinical needs of the units themselves but have not been supplied on the market, and must not be made until the approval of the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government where the units are located. 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 approval from the pharmaceutical supervisory and administrative departments of the central government or of the provinces, autonomous regions and municipalities directly under the central government, the medicinal preparations made by medical organizations can be shared among appointed medical organizations.
Medicinal preparations made by medical organizations may not be sold on the market.
| | 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准後方可配制。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准，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。
醫療機構配制的制劑，不得在市場銷售。
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Article 26. When purchasing pharmaceuticals, medical organizations must formulate 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 shall not be purchased and used.
| | 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。
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Article 27. Prescriptions being dispensed by the dispensers of medical organizations must be checked. Pharmaceuticals listed in prescriptions must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or re-signed by the doctors who wrote them.
| | 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。
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Article 28. Rules for storage of pharmaceuticals shall be formulated and implemented by medical organizations, which must adopt necessary measures to facilitate cold storage and protection against cold, moisture, insects and rodents to ensure the quality of pharmaceuticals.
| | 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。
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Chapter V Pharmaceutical Administration
| | 第五章 藥品管理
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Article 29 When producing a new medicine, it is necessary to submit information about the methods of production, quality indices, pharmacological and toxicological testing results, and other related materials and sales as required by the pharmaceutical supervisory and administrative department of the State Council, only after whose approval can clinical tests be carried out. Certifying measures for clinical test units shall be jointly formulated by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of health under the State Council.
A new medicine which has completed its clinical tests and been approved after appraisal shall be issued a certificate of new medicine by the pharmaceutical supervisory and administrative department under the State Council.
| | 第二十九條 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准後，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。
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准，發給新藥證書。
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Article 30 The pharmaceutical non-clinical safety appraisal and research units and the clinical test units must respectively carry out the quality control standard for pharmaceutical non-clinical research and the quality control standard for pharmaceutical clinical test.
The quality control standard for pharmaceutical non-clinical research and the quality control standard for pharmaceutical clinical test shall be formulated by the department appointed by the State Council.
| | 第三十條 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。
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。
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Article 31. A new medicine or medicine standardized by the State can be put into production only after the pharmaceutical supervisory and administrative department under the State Council has approved it and issued a registered document of approval. However, this does not apply to the production of traditional Chinese medicinal herbs and traditional Chinese medicine prepared in ready-to-use forms that are not controlled under a registered document of approval. For those traditional Chinese medicinal herbs and traditional Chinese medicines prepared in ready-to-use forms that are controlled with registered document of approval, the pharmaceutical supervisory and administrative department under the State Council and the administrative department of traditional Chinese medicines under the State Council shall jointly formulate their type catalogue.
Pharmaceutical producing enterprises can produce medicine only after obtaining the registered document of approval.
| | 第三十一條 生產新藥或者已有國家標准的藥品的，須經國務院藥品監督管理部門批准，並發給藥品批准文號；但是，生產沒有實施批准文號管理的中藥材和中藥飲片除外。實施批准文號管理的中藥材、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。
藥品生產企業在取得藥品批准文號後，方可生產該藥品。
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Article 32. Pharmaceuticals must meet the pharmaceutical standards of the State. Article 10 (2) of this Law shall be applied to traditional Chinese medicines prepared in ready-to-use forms.
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.
The Pharmacopoeia Committee organized by the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the formulation and revision of the State pharmaceutical standards. The pharmaceutical inspection institutions of the pharmaceutical supervisory and administrative department under the State Council shall be responsible for the designation of State standard and contrastive pharmaceuticals.
| | 第三十二條 藥品必須符合國家藥品標准。中藥飲片依照本法第十條第二款的規定執行。
國務院藥品監督管理部門頒布的《中華人民共和國藥典》和藥品標准為國家藥品標准。
國務院藥品監督管理部門組織藥典委員會，負責國家藥品標准的制定和修訂。
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准品、對照品。
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Article 33. The pharmaceutical supervisory and administrative department under the State Council may organize pharmaceutical, medicinal and other technological personnel to carry out examination and evaluation of new medicines, and to reevaluate medicines already placed into production.
| | 第三十三條 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，對已經批准生產的藥品進行再評價。
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Article 34 Pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical organizations must purchase pharmaceuticals from the qualified enterprises with the certificates for production and trade of pharmaceuticals. However, this does not apply to the purchase of the traditional Chinese medicinal herbs which are not controlled under the registered document of approval.
| | 第三十四條 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，購進沒有實施批准文號管理的中藥材除外。
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Article 35. For narcotics, psychotropic substances, toxic drugs for medicinal use, and radioactive drugs, the State Council shall formulate administrative measures to carry out special control.
| | 第三十五條 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。
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Article 36 .The State Council shall formulate detailed measures to carry out a protection system for the categorization of traditional Chinese medicines.
| | 第三十六條 國家實行中藥品種保護制度。具體辦法由國務院制定。
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Article 37 The State Council shall formulate detailed measures to carry out a classified control system for prescription pharmaceuticals and non-prescription pharmaceuticals.
| | 第三十七條 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。
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Article 38. Import of medicines whose curative effects are uncertain or poor, or which produce adverse reactions or have other harmful effects on people's health shall be prohibited.
| | 第三十八條 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。
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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.
Medicines to be imported in small quantities for urgent clinical needs by medical organizations or for personal use shall go through import formalities according to relevant regulations of the State.
| | 第三十九條 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准、安全有效的，方可批准進口，並發給進口藥品注冊證書。
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。
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Article 40 Pharmaceuticals must be imported through the ports which allow the import of pharmaceuticals, and the pharmaceutical import enterprise shall submit a report to the pharmaceutical supervisory and administrative department of the place where the port is located. Customs shall rely on the Import Pharmaceuticals Customs Form issued by the pharmaceutical supervisory and administrative department to proceed. Those without the Import Pharmaceuticals Customs Form shall not be permitted to pass through customs.
The pharmaceutical supervisory and administrative department of the place where the port is located shall notify the pharmaceutical inspection institution to carry out selective examinations and inspections on the imported pharmaceuticals according to the regulations stipulated by the pharmaceutical supervisory and administrative department under the State Council, and to collect inspection fees according to Article 41(2) of this Law.
The nomination of the ports allowable for import of pharmaceuticals shall be jointly conducted by the pharmaceutical supervisory and administrative department under the State Council and the Customs Headquarters, and be reported to the State Council for approval.
| | 第四十條 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。
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。
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，報國務院批准。
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Article 41 The pharmaceutical supervisory and administrative department under the State Council shall appoint inspection institutions to carry out inspections before the sale and import of the following pharmaceuticals. Those having not passed the inspection shall not be allowed to be sold or imported.
| | 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：
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1 Bio-products prescribed by the pharmaceutical supervisory and administrative department of the State Council.
| | （一）國務院藥品監督管理部門規定的生物制品；
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2 Pharmaceuticals to be sold for the first time in China.
| | （二）首次在中國銷售的藥品；
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3 Other pharmaceuticals prescribed by the State Council.
The inspection fee and charge standards for the above-mentioned pharmaceuticals shall be jointly checked, ratified and promulgated by the financial department under the State Council and the competent authority of price control under the State Council. The measures for the collection of inspection fees shall be jointly formulated by the financial department under the State Council and the pharmaceutical supervisory and administrative department under the State Council.
| | （三）國務院規定的其他藥品。
前款所列藥品的檢驗費項目和收費標准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。
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Article 42. The pharmaceutical supervisory and administrative department under the State Council shall organize investigations on medicines which have been approved for production or import. It shall revoke the registered documents of approval or the registered certificate of import if it discovers that the curative effects of the medicines are uncertain or poor, that they produce serious adverse reactions, or that for other reasons they are harmful to people's health.
The medicines whose registered documents of approval or registered certificate of import have been revoked shall not be allowed to be produced, imported, sold or used. Those which have already been produced or imported shall be destroyed or disposed of under the supervision of the local pharmaceutical supervisory and administrative departments.
| | 第四十二條 國務院藥品監督管理部門對已經批准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，應當撤銷批准文號或者進口藥品注冊證書。
已被撤銷批准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。
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Article 43 A pharmaceutical reserve system shall be carried out by the State.
In case of serious disasters, plagues and other sudden emergencies, the department prescribed by the State Council can requisite the pharmaceuticals of enterprises to deal with such emergencies.
| | 第四十三條 國家實行藥品儲備制度。
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。
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Article 44 The State Council shall have the power to restrict or prohibit the export of the pharmaceuticals which are in short supply in the domestic market.
| | 第四十四條 對國內供應不足的藥品，國務院有權限制或者禁止出口。
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Article 45. Import or export licenses issued by the pharmaceutical supervisory and administrative department under the State Council are required for the import or export of narcotics and psychotropic substances falling within the restricted scope prescribed by the State.
| | 第四十五條 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《進口准許證》、《出口准許證》。
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Article 46. Newly discovered domestic medicinal plants or medicinal plants introduced from abroad may be sold only after they have been examined and approved by the pharmaceutical supervisory and administrative department under the State Council.
| | 第四十六條 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准後，方可銷售。
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Article 47. Measures for controlling medicinal materials traditionally used by local people in certain regions shall be jointly formulated by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of traditional Chinese medicines under the State Council.
| | 第四十七條 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。
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Article 48. The production (including preparation, which also applies to the following) and sale of fake medicines are prohibited. A fake medicine has any one of the following characteristics:
| | 第四十八條 禁止生產（包括配制，下同）、銷售假藥。
有下列情形之一的，為假藥：
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(1) Its components are different from those prescribed by state pharmaceutical standards.
| | （一）藥品所含成份與國家藥品標准規定的成份不符的；
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(2) A non-medical substance is passed off as a medicine, or one medicine is passed off as another.
A medicine shall be handled as fake medicine in any of the following cases:
| | （二）以非藥品冒充藥品或者以他種藥品冒充此種藥品的。
有下列情形之一的藥品，按假藥論處：
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(1) Where the use of the medicine has been prohibited by the pharmaceutical supervisory and administrative department under the State Council;
| | （一）國務院藥品監督管理部門規定禁止使用的；
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(2) Where the medicine is produced and imported without an approval dictated according to this Law, or the medicine is sold without being inspected as dictated according to this Law;
| | （二）依照本法必須批准而未經批准生產、進口，或者依照本法必須檢驗而未經檢驗即銷售的；
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(3) Where the medicine has deteriorated; or
| | （三）變質的；
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(4) Where the medicine has been contaminated;
| | （四）被汙染的；
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(5) Where the medicine has been produced with pharmaceutical materials without obtaining the dictated registration document of approval for the materials.
| | （五）使用依照本法必須取得批准文號而未取得批准文號的原料藥生產的；
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(6) Where the indications or the functions marked on the labels of the pharmaceuticals do not fall within the prescribed scope.
| | （六）所標明的適應症或者功能主治超出規定範圍的。
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Article 49. It is prohibited to produce and sell medicines of inferior quality, referring to the medicines whose components do not conform in quantity to that required by State pharmaceutical standards. A medicine shall be handled as medicine of inferior quality in any of the following cases:
| | 第四十九條 禁止生產、銷售劣藥。
藥品成份的含量不符合國家藥品標准的，為劣藥。
有下列情形之一的藥品，按劣藥論處：
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(1) An expiry date is not indicated or is altered; or
| | （一）未標明有效期或者更改有效期的；
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(2) A registration number is not indicated or is altered; or
| | （二）不注明或者更改生產批號的；
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(3) The medicine has passed its expiration date; or
| | （三）超過有效期的；
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(4) The packages and containers which have direct contact with pharmaceuticals have not obtained approval; or
| | （四）直接接觸藥品的包裝材料和容器未經批准的；
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(5) The medicine has been added presumptuously with color or preservative additives, spice, disguising odor or supplementary materials; or
| | （五）擅自添加著色劑、防腐劑、香料、矯味劑及輔料的；
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(6) The medicine fails to meet the prescribed standards in other respects.
| | （六）其他不符合藥品標准規定的。
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Article 50 The names of the pharmaceuticals listed in the State pharmaceutical standards are the generic names of the pharmaceuticals. Those names that have become the generic names of pharmaceuticals shall not be used as trademarks of pharmaceuticals.
| | 第五十條 列入國家藥品標准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。
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Article 51. Personnel in pharmaceutical producing or trading enterprises and in medical organizations who have direct contact with medicines must undergo an annual medical examination. Persons who have contracted contagious diseases or any other disease which may contaminate the medicine shall not be allowed to engage in any work which has direct contact with pharmaceuticals.
| | 第五十一條 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。
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Chapter VI Administration on Pharmaceutical Packaging
| | 第六章 藥品包裝的管理
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Article 52 The pharmaceutical packaging materials and containers which have direct contact with pharmaceuticals must meet the requirements of medicinal use, conform with the standards of protecting people's health and safety, and obtain the approval of the pharmaceutical supervisory and administrative departments at the same time as the approval of the pharmaceutical product.
Pharmaceutical producing enterprises shall use the packaging materials and containers which have direct contact with the pharmaceuticals only after they have obtained approval for them.
The pharmaceutical supervisory and administrative departments shall stop the use of those unqualified packaging materials and containers which have direct contact with the pharmaceuticals.
| | 第五十二條 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、安全的標准，並由藥品監督管理部門在審批藥品時一並審批。
藥品生產企業不得使用未經批准的直接接觸藥品的包裝材料和容器。
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。
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Article 53. Packaging must meet the specific quality requirements of the pharmaceuticals and facilitate their storage, transportation and medical use.
Traditional Chinese medicinal materials must be packaged before transportation. There must appear on the package the name of the medicine, place of production, date, name of the consignor, and an indication showing that the quality of the medicine meets standards.
| | 第五十三條 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。
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。
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Article 54. Packages of pharmaceuticals must be labeled and include directions for use in accordance with the regulations.
The label or directions must indicate the generic name of the medicine, components, specifications, the producer, registration number, batch number of the product, production date, expiry date, indications or major functions, directions for use, dosage, restrictions, adverse reactions and precautions.
Special indications must be printed as required on the labels of narcotics, psychotropic substances, toxic drugs for medical use, radioactive drugs, medicines for external use and non-prescriptive pharmaceuticals.
| | 第五十四條 藥品包裝必須按照規定印有或者貼有標簽並附有說明書。
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、批准文號、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。
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。
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Chapter VII Administration of the Prices and Advertising of Pharmaceuticals
| | 第七章 藥品價格和廣告的管理
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Article 55 For pharmaceuticals controlled by the fixed and directive pricing system of the government, the competent authority of pricing of the government shall fix and adjust the price with reason in conformity with the principles for fixing prices as prescribed by the Price Law of the PRC and according to the considerations of societal average costs, market supply and demand, and the level of societal tolerance to achieve accord between quality and price, to avoid excessive prices, and to safeguard the due interests of the users of the pharmaceuticals.
Pharmaceutical producing enterprises, trading enterprises and medical organizations must carry out the fixed price and directive price system of the government, and shall not presumptuously raise prices in any form.
Pharmaceutical producing enterprises shall provide the competent authority of pricing of the government with the producing and trading costs of pharmaceuticals and shall not refuse to report, make a false report or withhold the truth in such a report.
| | 第五十五條 依法實行政府定價、政府指導價的藥品，政府價格主管部門應當依照《中華人民共和國價格法》規定的定價原則，依據社會平均成本、市場供求狀況和社會承受能力合理制定和調整價格，做到質價相符，消除虛高價格，保護用藥者的正當利益。
藥品的生產企業、經營企業和醫療機構必須執行政府定價、政府指導價，不得以任何形式擅自提高價格。
藥品生產企業應當依法向政府價格主管部門如實提供藥品的生產經營成本，不得拒報、虛報、瞞報。
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Article 56 For the pharmaceuticals whose prices are to be adjusted by the market, the pharmaceutical producing enterprises, trading enterprises, and medical organizations shall fix the price in conformity with the principles of fairness, rationality, honesty, good faith and accord between quality and price to provide the users of the pharmaceuticals with reasonable prices.
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 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。
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于藥價管理的規定，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。
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Article 57 Pharmaceutical producing enterprises, trading enterprises and medical organizations shall, in accordance with this Law, provide the competent authority of pricing of the government with information such as the actual purchasing and selling prices and quantities of the pharmaceuticals.
| | 第五十七條 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。
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Article 58 Medical organizations shall provide the patient with the price list of the pharmaceuticals used. Medical organizations appointed by medical insurance shall faithfully promulgate the prices of frequently used pharmaceuticals according to prescribed measures to enhance the reasonable use of pharmaceuticals.
| | 第五十八條 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。
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Article 59 Pharmaceutical producing enterprises, trading enterprises and medical organizations are prohibited to give or receive secret commissions and other benefits during the purchasing and selling of pharmaceuticals.
Pharmaceutical producing enterprises, trading enterprises or their representatives are prohibited to give any property or other benefits under any name to the principals, buyers of pharmaceuticals, physicians and other relevant persons in the medical organizations where their pharmaceuticals are used. The principals, buyers of pharmaceuticals, physicians and other relevant persons are prohibited from receiving any property or other benefits under any name from pharmaceutical producing enterprises, trading enterprises or their agents.
| | 第五十九條 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。
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。
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Article 60 Advertisements of pharmaceuticals must be approved and issued a registration number of advertisement by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government of the place where the enterprises are located. In the absence of such registration numbers, advertisements for any medicines may not be placed.
Prescription pharmaceuticals may be introduced in medicinal and pharmaceutical magazines jointly appointed by the administrative department of health under the State Council and the pharmaceutical supervisory and administrative department under the State Council, but shall not be advertised through mass media or publicized in any other form to the public.
| | 第六十條 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准，並發給藥品廣告批准文號；未取得藥品廣告批准文號的，不得發布。
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。
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Article 61 The contents of pharmaceutical advertisement must be true, legitimate, and be based on the directions for use approved by the pharmaceutical supervisory and administrative department under the State Council, and be also free of falsehood.
Advertisements of pharmaceuticals shall not contain any unscientific assertion or guarantee on effects, and shall not be endorsed using the names and images of government bodies, pharmaceutical scientific research units, academic organizations, experts, scholars, physicians and sufferers.
The advertisements of non-pharmaceuticals shall not be involved in the publicizing of pharmaceuticals.
| | 第六十一條 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准的說明書為准，不得含有虛假的內容。
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。
非藥品廣告不得有涉及藥品的宣傳。
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Article 62 The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall inspect on the pharmaceutical advertisements they approve, and shall notify and advise the administrative departments of advertising if the advertisements is not in conformity with this Law and the Advertisement Law of the PRC. The administrative departments of advertising shall deal with such advertisements according to relevant regulations.
| | 第六十二條 省、自治區、直轄市人民政府藥品監督管理部門應當對其批准的藥品廣告進行檢查，對于違反本法和《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。
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Article 63 In the absence of regulations as provided in this Law, the Price Law of the PRC and the Advertisement Law of the PRC shall be applied to the control of pharmaceutical prices and advertisements.
| | 第六十三條 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。
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Chapter VIII Supervision over Pharmaceuticals
| | 第八章 藥品監督
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Article 64 Pharmaceutical supervisory and administrative departments are authorized to conduct, in accordance with laws and administrative regulations, supervision and inspection over the research,development, production and trade of pharmaceuticals which they have approved, as well as the medical organizations' use of pharmaceuticals. The units and individuals concerned shall not refuse to comply.
Pharmaceutical supervisory and administrative departments shall present certificate documents while conducting supervision and inspection, and shall not divulge technological and business secrets gained during the process of supervision and inspection.
| | 第六十四條 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。
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。
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Article 65 According to the needs of supervision and inspection, pharmaceutical supervisory and administrative departments may conduct sampling examinations on the quality of pharmaceuticals. The sampling examinations shall be conducted according to relevant regulations and shall not be charged a fee. The expenses incurred shall be dispensed with in conformity with the regulations prescribed by the State Council.
Pharmaceutical supervisory and administrative departments may take administrative compulsory measures including sequestration and banning against pharmaceuticals and other relevant materials which have been proven to be of possible harm to people's health; administrative measures must be taken within seven days. For pharmaceuticals which need to be inspected, decisions regarding administrative handling must be made within 15 days from the date of issue of the inspection reports.
| | 第六十五條 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。
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。
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Article 66 The pharmaceutical supervisory and administrative departments under the State Council and of the provinces, autonomous regions and municipalities directly under the central government shall regularly promulgate the results of sampling examinations and inspections on the quality of pharmaceuticals, and shall, in the case of improperly published statements, amend such statements in the original published documents.
| | 第六十六條 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。
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Article 67. If a party concerned disagrees with the inspection decision made by the inspection institutions, it may apply for re-inspection to the original inspection institutions or ones established or appointed by the pharmaceutical supervisory and administrative departments of superior levels within seven days from the date of receiving the pharmaceutical inspection decision, and may directly apply for re-inspection to the inspection institutions established or appointed by the pharmaceutical supervisory and administrative department under the State Council. The inspection institutions which have accepted the re-inspections shall conclude the re-inspections within the time limit prescribed by the pharmaceutical supervisory and administrative department under the State Council.
| | 第六十七條 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。
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Article 68 Pharmaceutical supervisory and administrative departments shall follow up on the inspections of the pharmaceutical producing enterprises or pharmaceutical trading enterprises which they have certified in conformity with the “Quality Control Standard of Pharmaceutical Production” and the “Quality Control Standard of Pharmaceutical Trade.”
| | 第六十八條 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。
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Article 69 The local people's governments and pharmaceutical supervisory and administrative departments shall not restrict or exclude the entrance of pharmaceuticals produced according to this Law by pharmaceutical producing enterprises in other regions of the country through the excuse of conducting inspection , examination and approval of the pharmaceuticals.
| | 第六十九條 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。
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Article 70 Pharmaceutical supervisory and administrative departments and the pharmaceutical inspection institutions they have established, as well as the institutions exclusively engaged in pharmaceutical inspection they have appointed, shall not participate in pharmaceutical production and trade, and shall not endorse or supervise the production and sale of pharmaceuticals in their own names.
The functionaries of pharmaceutical supervisory and administrative departments,of the pharmaceutical inspection institutions they established, and of the institutions exclusively engaged in the inspection of pharmaceuticals they appointed, shall not participate in pharmaceutical production and trade.
| | 第七十條 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。
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。
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Article 71 A reporting system over any adverse reactions of pharmaceuticals shall be practiced by state. Pharmaceutical producing enterprises, pharmaceutical trading enterprises, and medical institutions shall conduct regular surveys on the quality, curative effects and adverse reactions of the pharmaceuticals they have produced, traded or used. When serious adverse reactions possibly related to the use of the pharmaceuticals are discovered, they must be promptly reported to the pharmaceutical supervisory and administrative departments and the administrative departments of health of the provinces, autonomous regions and municipalities directly under the central government. Detailed measures shall be formulated jointly by the pharmaceutical supervisory and administrative department under the State Council and the administrative department of health under the State Council.
Regarding the pharmaceuticals which have been confirmed to cause serious adverse reactions, the pharmaceutical supervisory and administrative department under the State Council and of the provinces, autonomous regions and municipalities directly under the central government, shall take urgent control measures including the cessation of the production, sale, and use of the pharmaceuticals, shall organize appraisals within five days, and shall make decisions on their administrative handling within 15 days from the conclusion date of the appraisals.
| | 第七十一條 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。
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。
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Article 72. The organs or personnel in charge of pharmaceutical inspection in pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical organizations shall receive operational guidance from the pharmaceutical inspection institutions established by local pharmaceutical supervisory and administrative departments.
| | 第七十二條 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。
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CHAPTER IX LEGAL RESPONSIBILITY
| | 第九章 法律責任
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Article 73. Those who produce or trade in medicines without obtaining a Pharmaceutical Production License, Pharmaceutical Trade License, or Dispensing Permit of Medical Organizations,shall be placed under ban, have the unlawfully produced and sold medicines and any unlawful income confiscated, and may concurrently be fined a sum of money more than two but less than five times the value of the medicines unlawfully made or sold (including both sold and unsold pharmaceuticals, which also applies below). Those whose acts constitute a crime shall be investigated for criminal liabilities.
| | 第七十三條 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。
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Article 74 Those who produce and sell fake medicines shall have his unlawfully produced or sold medicines and any unlawful income confiscated, and concurrently be fined a sum of money more than two but less than five times the value value of the medicines unlawfully produced and sold.Those who have an approval certificate of pharmaceuticals shall have the certificate revoked, and be ordered to suspend production or business operations pending rectification; if the circumstances are serious, the party shall have Pharmaceutical Production License, or Pharmaceutical Trade License or Dispensing Permit of Medical Organizations revoked. Those whose acts constitute a crime shall be investigated for criminal liabilities.
| | 第七十四條 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；有藥品批准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。
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Article 75 Those who produce and sell medicines of inferior quality shall have his unlawfully made and sold medicines and any unlawful income confiscated, and be concurrently fined the sum of money more than two but less than three times the value of the medicines unlawfully made or sold; if the circumstances are serious, the party shall be ordered to suspend production or business pending rectification, or have the pharmaceutical approval certificate revoked and his Pharmaceutical Production License, or Pharmaceutical Trade License or Dispensing Permit of Medical Organizations revoked. Those whose acts constitute a crime will be investigated for criminal liabilities.
| | 第七十五條 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准證明文件、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。
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Article 76 The person-in-charge or personnel directly liable in the enterprise or other unit which produces and sells fake medicines or produces and sells pharmaceuticals of inferior quality shall not be permitted to engage in the production and trade of pharmaceuticals for ten years, if the circumstances are serious.
The producers' supplementary materials, packaging materials and production equipment which are used exclusively for producing fake medicines and medicines of inferior quality shall be confiscated.
| | 第七十六條 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。
對生產者專門用于生產假藥、劣藥的原輔材料、包裝材料、生產設備，予以沒收。
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Article 77 Those who provide facilities including transportation, preservation and storage that have been or should have been aware of the fakery or inferior quality of the pharmaceuticals, shall have the entirety of his income from such transportation, preservation and storage confiscated, and concurrently be fined a sum of money more than 50% but less than three times the value of the unlawful income. Those whose acts constitute a crime shall be investigated for criminal liabilities.
| | 第七十七條 知道或者應當知道屬于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。
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Article 78 The notice of penalties on fake medicines and medicines of inferior quality shall indicate the inspection results of the inspection institution. However, this does not apply to the circumstances prescribed by Article 48(3)(a)(b)(e)(f) and Article 49 (3) of this Law.
| | 第七十八條 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。
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Article 79 Pharmaceutical producing enterprises, trading enterprises, pharmaceutical non-clinical safety appraisal research institution, and pharmaceutical clinical testing institutions, shall be served a warning and be ordered to amend themselves within a prescribed time limit if they do not carry out the stipulations of the “Quality Control Standard of Pharmaceutical Production,” the “Quality Control Standard of Pharmaceutical Trade,” the quality control standard of pharmaceutical non-clinical research, and the quality control standard of pharmaceutical clinical testing. Those who do not rectify their mistakes within the prescribed time limit shall be ordered to suspend production and business operations pending rectification, and be concurrently fined more than 5000 but less than 20,000 RMB. If the circumstances are serious, they shall have their Pharmaceutical Production License, Pharmaceutical Trading License or Dispensing Permit of Medical Organizations revoked.
| | 第七十九條 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。
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Article 80 If any pharmaceutical producing enterprises, pharmaceutical trading enterprises or medical organizations violate Article 34 of this Law and purchase medicines from enterprises without the Pharmaceutical Production License or Pharmaceutical Trade License, they shall be ordered to amend themselves, have their unlawfully purchased medicines confiscated, and be concurrently fined the sum of money more than two but less than five times the value of the unlawfully purchased medicines. If they have obtained any unlawful income, the unlawful income shall be confiscated; if the circumstances are serious, their Pharmaceutical Production License, Pharmaceutical Trading License or Practicing Permit of Medical Organizations shall be revoked.
| | 第八十條 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。
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Article 81 Those who import pharmaceuticals with a pharmaceutical import registration document and fail to register according to this Law at the pharmaceutical supervisory and administrative department at the location of the port allowed for pharmaceutical import, shall be served a warning and be ordered to correct its mistakes within a prescribed time limit. Those who have not corrected its mistakes within the prescribed time limit shall have their registration document to import pharmaceuticals revoked.
| | 第八十一條 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。
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Article 82 Those who forge, alter, trade, lease or lend licenses or pharmaceutical approval certificates, shall have their unlawful income confiscated and be concurrently fined the sum of money more than two but less than three times the amount of the unlawful income. If the party has not obtained unlawful income yet, it will be fined more than 20,000 but less than 100,000 RMB; if the circumstances are serious, the Pharmaceutical Production License, Pharmaceutical trading License or Dispensing Permit of Medical Organizations of the seller, lessor or lender shall be revoked, or the pharmaceutical approval certificate shall be recalled. Those whose acts constitute a crime shall be investigated for criminal liabilities.
| | 第八十二條 偽造、變造、買賣、出租、出借許可證或者藥品批准證明文件的，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》或者撤銷藥品批准證明文件；構成犯罪的，依法追究刑事責任。
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Article 83 Those who violate this Law by providing false certificates or samples of documents, or obtaining the Pharmaceutical Production License, the Pharmaceutical Trading License, the Dispensing Permit of Medical Organizations or pharmaceutical approval certificates through cheating, shall have their Pharmaceutical Production License, Pharmaceutical Trade License, or Dispensing Permit of Medical Organizations revoked, have their pharmaceutical approval certificates revoked, have their application rejected for five years, and have a concurrent fine of more than 10,000 but less than 30,000 RMB be imposed upon them.
| | 第八十三條 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》或者藥品批准證明文件的，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》或者撤銷藥品批准證明文件，五年內不受理其申請，並處一萬元以上三萬元以下的罰款。
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Article 84 If a medical organization sells its preparations on the market, it shall be ordered to correct its mistakes, have its unlawfully sold preparations confiscated and concurrently be fined a sum of money more than two but less than three times the value of the unlawfully sold preparations.If it has obtained any unlawful income, the unlawful income shall be confiscated.
| | 第八十四條 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。
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Article 85 If a pharmaceutical trading enterprise violates Article 18 and Article 19 of this law, it shall be ordered to amend itself and be served a warning. If the circumstances are serious, its Pharmaceutical Trading License shall be revoked.
| | 第八十五條 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》。
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Article 86 A medicine whose mark is not in conformity with Article 54 of this Law shall be handled as fake medicine or medicine of inferior quality. In addition, a correction shall be made and a warning shall be served. If the circumstances are serious, the approval certificate of this medicine shall be revoked.
| | 第八十六條 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，撤銷該藥品的批准證明文件。
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Article 87 A pharmaceutical inspection institution which produces false inspection reports, where the circumstances are so serious as to constitute a crime, shall be investigated for criminal liabilities; if a crime is not constituted, it shall be ordered to amend and be served a warning. The institution shall be concurrently imposed a fine of more than 30,000 but less than 50,000 RMB, and the person-in-charge and other personnel directly liable shall be demoted, dismissed from their posts, or expelled according to law, and shall be concurrently be fined less than 30,000 RMB. If any unlawful income has been obtained, the unlawful income shall be confiscated. If the circumstances are serious, the inspection qualification certificate shall be revoked. If an inspection institution produces false inspection reports and causes serious consequences, it shall bear corresponding liabilities for compensation.
| | 第八十七條 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。
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Article 88 The decision to impose administrative sanctions stipulated from Article 73 to Article 87 by this Law shall be made by the pharmaceutical supervisory and administrative departments at or above the county level in conformity with the division of functions prescribed by the pharmaceutical supervisory and administrative department under the State Council. The original issue and approval departments shall decide regarding the revocation of the Pharmaceutical Production License, the Pharmaceutical Trading License, the Dispensing Permit of Medical Organizations, the practicing permit of medical organizations, and the pharmaceutical approval certificates.
| | 第八十八條 本法第七十三條至第八十七條規定的行政處罰，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准證明文件的，由原發證、批准的部門決定。
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Article 89 Violations of Article 55, 56, 57 of this Law concerning the price control of pharmaceuticals shall be punished according to the Price Law of the People's Republic of China.
| | 第八十九條 違反本法第五十五條、第五十六條、第五十七條關于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。
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Article 90 If pharmaceutical producing enterprises, trading enterprises and medical organizations give or receive commissions or other interests in secret during the purchase or sale of pharmaceuticals; and if pharmaceutical producing enterprises, trading enterprises or their agents give any property or other interests to the directors, buyers, physicians and other relevant persons in the medical organizations where their medicines are used, a fine of more than 10,000 but less than 200,000 RMB shall be imposed and the unlawful income shall be confiscated by the government body of industry and commerce administration who, if the circumstances are serious, shall revoke the business licenses of the pharmaceutical producing enterprises and pharmaceutical trading enterprises, and shall notify the pharmaceutical supervisory and administrative departments which shall revoke the Pharmaceutical Production License and Pharmaceutical Trading License. If a crime is constituted, an investigation shall be made for criminal liabilities.
| | 第九十條 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。
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Article 91 If directors or buyers of pharmaceutical producing enterprises or trading enterprises receive any property or other interests from other producing enterprises, trading enterprises or their agents during the purchase or sale of medicines, they shall be punished according to relevant regulations and shall have their unlawful income confiscated. If a crime is constituted, an investigation shall be made for criminal liabilities.
If the directors, buyers, physicians or other relevant persons in medical organizations receive any property or other interests from pharmaceutical producing enterprises, pharmaceutical trading enterprises or their agents, they shall be punished by the administrative departments of health or the work units where they work, and have their unlawful income confiscated. If practicing physicians seriously violate the law, his practice certificate shall be revoked by the administrative departments of health. If a crime is constituted, an investigation shall be made for criminal liabilities in conformity with relevant laws and regulations.
| | 第九十一條 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。
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。
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Article 92 Those who act against the administrative regulations concerning pharmaceutical advertisement as provided in this Law shall be sanctioned in conformity with the Advertisement Law of the PRC, have its advertisement registration number revoked by the pharmaceutical supervisory and administrative departments from which the registration number has been issued, and its application for the approval of the advertisement regarding this variety of medicines shall not be accepted for one year. If a crime is constituted, an investigation of criminal liabilities shall be made in conformity with relevant laws and regulations.
If a pharmaceutical supervisory or administrative department does not perform its duty of inspection on pharmaceutical advertisements which results in the publishing of advertisements containing falsehoods or other content against laws and administrative regulations, the directly liable person in charge and other responsible personnel shall be subject to administrative sanction. If their acts constitute a crime, they shall be investigated for criminal liabilities in conformity with relevant regulations.
| | 第九十二條 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，並由發給廣告批准文號的藥品監督管理部門撤銷廣告批准文號，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。
藥品監督管理部門對藥品廣告不依法履行審查職責，批准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。
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Article 93 If pharmaceutical producing enterprises, trading enterprises or medical organizations act against this law which results in damages to the users of pharmaceuticals, they shall bear liabilities of compensation in conformity with relevant regulations.
| | 第九十三條 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。
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Article 94 If a pharmaceutical supervisory and administrative department violates this law with one of the following acts, a competent authority of a higher level or a oversight organization shall order it to withdraw the unlawfully issued certificates, revoke the pharmaceutical approval certificates, and render administrative sanctions against the directly liable person in charge and other responsible personnel. If their acts constitute a crime, they shall be investigated for criminal liabilities.
| | 第九十四條 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、撤銷藥品批准證明文件，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：
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(1) issue a certificate of qualification to an enterprise which does not meet the requirements of the “Quality Control Standard of Pharmaceutical Production” and the “Quality Control Standard of Pharmaceutical Trading,” fail to conduct inspections according to relevant regulations on the enterprises which have already obtained certificates, or fail to order the unqualified enterprises to amend themselves or revoke their certificates according to relevant regulations; or
| | （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；
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(2) issue a Pharmaceutical Production License, a Pharmaceutical Trading License or a Dispensing Permit of Medical Organizations to a unit which does not meet legal requirements;
| | （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；
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(3) issue a registration certificate of import to a medicine which does not meet the requirements for import; or
| | （三）對不符合進口條件的藥品發給進口藥品注冊證書的；
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(4) approve a clinic test when the requirements for clinic tests are not met, or issue certificates of new medicines and pharmaceutical approval document numbers when requirements for production are not met.
| | （四）對不具備臨床試驗條件或者生產條件而批准進行臨床試驗、發給新藥證書、發給藥品批准文號的。
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Article 95 If a pharmaceutical supervisory and administrative department, or an inspection institution it has established, or an organization exclusively engaged in pharmaceutical inspection it has appointed, participates in the production and trade of pharmaceuticals, the responsible authority of a higher level or a oversight organization shall order it to amend itself and have its unlawful income confiscated. If the circumstances are serious, the directly liable person in charge and other responsible personnel shall be subject to administrative sanctions.
If a staff member in a pharmaceutical supervisory and administrative department, or in an inspection institution it has established, or in an organization exclusively engaged in pharmaceutical inspection it has appointed, participates in the production and trade of pharmaceuticals, he or she shall be subject to administrative sanction.
| | 第九十五條 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。
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。
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Article 96 If a pharmaceutical supervisory and administrative department or a pharmaceutical inspection institution it has established or appointed unlawfully collects inspection fees during a pharmaceutical supervision and inspection, it shall be ordered by the government bodies concerned to make reimbursements, and the directly liable person and other responsible personnel shall be subject to administrative sanctions. If the circumstances are serious, the certificate of qualification of the inspection institution which has unlawfully collected inspection fees shall be revoked.
| | 第九十六條 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。
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Article 97 A pharmaceutical supervisory and administrative department shall perform its duty of supervision and inspection according to laws and regulations, and shall supervise the production and trade of the enterprises which have obtained a Pharmaceutical Production License or a Pharmaceutical Trade License according to the regulations of this Law.
If an enterprise which has obtained a Pharmaceutical Production License or a Pharmaceutical Trade License produces and sells fake medicines and medicines of inferior quality, the enterprise shall be investigated for legal liabilities according to laws and regulations. In addition, the directly liable person in charge and other responsible personnel in the pharmaceutical supervisory and administrative department who have neglected or have been derelict in their duty shall be subject to administrative sanction. If a crime is constituted, the party shall be investigated for criminal liabilities according to laws and regulations.
| | 第九十七條 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。
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、瀆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。
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Article 98 A pharmaceutical supervisory and administrative department shall, within a prescribed time limit, order a pharmaceutical supervisory and administrative department of a lower level to correct an administrative act which is not in conformity with this Law. If the administrative act is not corrected within the prescribed time limit, the department shall have the power to change or repeal it.
| | 第九十八條 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。
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Article 99 If the personnel of the pharmaceutical supervision and administration misuse their authority, engage in irregular practices due to favoritism, or neglect their duties to such an extent that a crime is constituted, they shall be investigated for criminal liabilities. If their acts have not constituted a crime, they shall be subject to administrative sanctions.
| | 第九十九條 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。
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Article 100 If a Pharmaceutical Production License or a Pharmaceutical Trade License is revoked according to this Law, the pharmaceutical supervisory and administrative department shall notify the industry and commerce administrative department to alter or annul the registration.
| | 第一百條 依照本法被吊銷《藥品生產許可證》、《藥品經營許可證》的，由藥品監督管理部門通知工商行政管理部門辦理變更或者注銷登記。
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Article 101 The value of goods as prescribed in this chapter is designated according to the marked price of the unlawfully made or sold medicines. In the absence of a marked price, the value of goods shall be designated according to the market price of pharmaceuticals of the same kind.
| | 第一百零一條 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。
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Chapter X Supplementary Provisions
| | 第十章 附則
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Article 102 For the purpose of this Law, the following definitions are offered:
" Pharmaceuticals " means the articles intended for use in the prevention, treatment or diagnosis of human diseases, or intended to effect the purposive regulation of human physiological functions, for which indications or major functions, usage and dosage are prescribed. They include raw traditional Chinese medicinal materials, traditional medicines prepared in ready-to-use forms, and other prepared Chinese medicines, medicinal chemicals and their preparations, antibiotics, biochemical medicines, radioactive drugs, serums, vaccines, blood products, diagnostic aids, etc.
" Supplementary materials " means the excipients and additives used for the production and dispensing of pharmaceuticals.
" Pharmaceutical producing enterprise " means an enterprise exclusively or partly engaged in the production of pharmaceuticals.
" Pharmaceutical trading enterprise " means an enterprise exclusively or partly engaged in the trade of pharmaceuticals.
| | 第一百零二條 本法下列用語的含義是：
藥品，是指用于預防、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。
輔料，是指生產藥品和調配處方時所用的賦形劑和附加劑。
藥品生產企業，是指生產藥品的專營企業或者兼營企業。
藥品經營企業，是指經營藥品的專營企業或者兼營企業。
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Article 103. Measures for the control of cultivation, collection and breeding of all categories of medicinal materials used in traditional Chinese medicine shall be separately formulated by the State Council .
| | 第一百零三條 中藥材的種植、采集和飼養的管理辦法，由國務院另行制定。
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Article 104. The State Council shall formulate detailed measures to carry out special control on the circulation of preventive bio-products.
| | 第一百零四條 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。
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Article 105 Detailed measures for the implementation of this law by the Chinese People's Army shall be formulated by the State Council and the Central Military Committee of the State on the basis of this Law.
| | 第一百零五條 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。
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| Article 106 This Law shall enter into force as of December 1, 2001. | | 第一百零六條 本法自２００１年１２月１日起施行。
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