第一條為加強藥品監督管理，保證藥品質量，增進藥品療效，保障人民用藥安全，維護人民身體健康，特制定本法。
[Article 1] This law has been drawn up in order to strengthen drug control and administration, ensure the quality of drugs, enhance the efficacy of drugs, guarantee safe drug use and safeguard the physical health of the people.

第二條國務院衛生行政部門主管全國藥品監督管理工作。
[Article 2] The State Council department responsible for health administration is the body in charge of national drug control and administration.

第三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 medicines and traditional medicines, and fully utilises them in the prevention and treatment of disease, as well as in health care.

國家保護野生藥材資源 鼓勵培育中藥材。
The State safeguards resources of uncultivated medicinal materials and encourages the cultivation of raw materials used for traditional Chinese medicines.

第二章藥品生產企業的管理
CHAPTER II ADMINISTRATION OF DRUG-PRODUCING ENTERPRISES

第四條開辦藥品生產企業必須由所在省、自治區、直轄市藥品生產經營主管部門審查同意，經所在省、自治區、直轄市衛生行政部門審核批準，并發給《藥品生產企業許可證》。
[Article 4] The establishment of a drug-producing enterprise must be examined and agreed to by the department in charge of drug production and handling in the province, autonomous region or municipality under the direct control of the Central Government in which the enterprise is located. It shall be subject to examination and approval by the department responsible for health administration in the province, autonomous region or municipality under the direct control of the Central Government, which shall issue the "Drug-production Enterprise Licence".

無《藥品生產企業許可證》的工商行政管理部門不得發給《營業執照》。
Without a "Drug-production Enterprise Licence", the department administering industry and commerce may not issue a "Business Licence".

《藥品生產企業許可證》應當規定有效期，到期重新審查發證。具體辦法由國務院衛生行政部門規定。
The "Drug-production Enterprise Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be determined by the State Council department responsible for health administration.

第五條開辦藥品生產企業必須具備以下條件：
[Article 5] The establishment of an enterprise to produce drugs must satisfy the following conditions:

（一）具有與所生產藥品相適應的藥師或者助理工程師以上技術人員及技術工人。
(1) It must employ pharmacists, technical personnel above the rank of assistant engineer and technical workers appropriate to the drug production carried out by the enterprise.

中藥飲片加工企業沒有藥師或者助理工程師以上技術人員，配備熟悉藥性并經縣級以上衛生行政部門審查登記的藥工人員。
Where an enterprise engaged in the processing of traditional Chinese medicine does not have a pharmacist or technical personnel of a rank above that of assistant engineer, it may use drug industry personnel with an intimate knowledge of drugs who have been examined and registered by a department of health administration above the county level.

（二）具有與所生產藥品相適應的廠房、設施和衛生環境。
(2) It must have a factory building, facilities and a hygienic environment appropriate to its production of drugs.

（三）具有能對所生產藥品進行質量檢驗的機構或者人員以及必要的儀器設備。
(3) It must have an organisation or personnel capable of carrying out quality examinations on the drugs produced as well as the necessary instruments and equipment.

第六條藥品必須按照工藝規程進行生產，生產記錄必須完整準確。
[Article 6] The production of drugs must be carried out in accordance with the correct technological procedures; production records shall be kept in detail and accurately.

中藥飲片的炮制必須符合《中華人民共和國藥典》,或者省、自治區、直轄市衛生行政部門制定的《炮制規范》的規定。
The preparation of Chinese medicines shall be in accordance with the "Pharmacopoeia of the People's Republic of China", or in accordance with the "Preparation Standards" laid down by the department administering health in that province, autonomous region or municipality under the direct control of the Central Government.

第七條生產藥品所需的原料、輔料以及直接接觸藥品的容器和包裝材料，必須符合藥用要求。
[Article 7] Raw materials and supplementary materials required for the production of drugs as well as containers and packing materials which come into direct contact with drugs shall meet standards required for pharmaceutical use.

第八條藥品出廠前必須經過質量檢驗；不符合標準的，不得出廠。
[Article 8] Before drugs leave the factory, they must pass a quality examination. If they do not reach the required standard, they must not leave the factory.

第九條藥品生產企業必須按照國務院衛生行政部門制定的《藥品生產質量管理規范》的要求，制定和執行保證藥品質量的規章制度和衛生要求。
[Article 9] Drug-producing enterprises must formulate and implement a system of rules and regulations and hygiene requirements to guarantee the quality of drugs in accordance with the requirements of the "Standards for the Administration of Drug-production Quality" laid down by the department of the State Council administering health.

第三章藥品經營企業的管理
CHAPTER III ADMINISTRATION OF DRUG-HANDLING ENTERPRISES

第十條開辦藥品經營企業必須由所在地藥品生產經營主管部門審查同意，經縣級以上衛生行政部門審核批準，并發給《藥品經營企業許可證》。無《藥品經營企業許可證》的，工商行政管理部門不得發給《營業執照》。
[Article 10] The establishment of a drug-handling enterprise must be examined and agreed to by the department responsible for drug production and handling in the place where the enterprise is situated, and must be examined and approved by a health department at county level or above, which will issue a "Drug-handling Enterprise Licence", without which the department administering industry and commerce may not issue a "Business Licence".

《藥品經營企業許可證》應當規定有效期，到期重新審查發證。具體辦法由國務院衛生行政部門規定。
A "Drug-handling Enterprise Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be determined by the department of the State Council administering health.

第十一條開辦藥品經營企業必須具備以下條件：
[Article 11] The establishment of a drug-handling enterprise must satisfy the following conditions:

（一）具有與所經營藥品相適應的藥學技術人員。
(1) It must employ pharmaceutical technicians appropriate to the medicines handled.

經營中藥的企業和兼營藥品的企業沒有藥學技術人員.配備熟悉所經營藥品的藥性并經縣級以上衛生行政部門審查登記的藥工人員。
Where an enterprise engaged in the handling of Chinese medicines or partly engaged in handling drugs does not have a pharmaceutical technician it may use drug industry personnel with an intimate knowledge of the medicinal nature of the drugs handled who have been examined and registered by a department administering health at above county level.

（二）具有與所經營藥品相適應的營業場所、設備、倉儲設施和衛生環境。
(2) It must have business premises, equipment, storage facilities and a hygienic environment appropriate to the drugs handled.

第十二條收購藥品，必須進行質量驗收；不合格的，不得收購。
[Article 12] On purchasing drugs, quality examinations must be carried out; if the drugs do not come up to standard, they may not be purchased.

第十三條銷售藥品必須準確無誤，并正確說明用法、用量和注意事項；
[Article 13] In selling drugs, it is necessary to be exact and accurate; the method of use, dosage and points to note must be explained precisely.

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。
In making up prescriptions, checks must be carried out; the drugs itemised in the prescription must not be altered or substituted without authorisation.

對有配伍禁忌或者超劑量的處方應當拒絕調配；必要時經處方醫生更正或者重新簽字，方可調配。
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 and signed it again, it may be made up.

銷售地道中藥材，必須標明產地。
Where authentic Chinese medicines are sold, they shall be labelled to indicate the place of origin.

第十四條藥品倉庫必須制定和執行藥品保管制度，采取必要的冷藏、防潮、防蟲、防鼠等措施。
[Article 14] Drug warehouses shall lay down and implement a system of rules and regulations for the storage of drugs and take measures necessary in relation to cold storage, protection against damp, and protection from insects, rodents, etc.

藥品入庫出庫必須執行檢查制度。
An inspection system shall be put into effect in relation to drugs which are brought into or removed from the warehouse.

第十五條城鄉集市貿易市場可以出售中藥材，國家另有規定的除外。
[Article 15] Chinese medicinal materials may be sold in town and country trading markets except where 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持有《藥品經營企業許可證》的除外。
Drugs other than Chinese medicinal materials may not be sold in the trading markets of country towns, unless a "Drug-handling Enterprise Licence" is held.

第四章醫療單位的藥劑管理
CHAPTER IV ADMINISTRATION OF DRUGS IN MEDICAL TREATMENT UNITS

第十六條醫療單位必須配備與其醫療任務相適應的藥學技術人員，非藥學技術人員不得直接從事藥劑技術工作。
[Article 16] Medical treatment units must be staffed with the number of pharmaceutical technicians appropriate to their medical treatment responsibilities. Personnel who are not pharmaceutical technicians may not be engaged directly in pharmaceutical technical work.

第十七條醫療單位配制制劑必須經所在省、自治區、直轄市衛生行政部門審查批準，并發給《制劑許可證》。
[Article 17] The making up of drugs by medical treatment units must be examined and approved by the department in charge of health administration in the province, autonomous region or municipality under the direct control of the Central Government where the unit is situated, which will issue a "Dispensing Licence".

《制劑許可證》應當規定有效期，到期重新審查發證。具體辦法由國務院衛生行政部門規定。
A "Dispensing Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be laid down by the department of the State Council administering health.

第十八條醫療單位配制制劑必須具有能夠保證制劑質量的設施、檢驗儀器和衛生條件。
[Article 18] A medical treatment unit which makes up drugs must have adequate facilities, instruments for examination and hygienic conditions to ensure the quality of the drugs prepared.

第十九條醫療單位配制的制劑，必須根據臨床需要并按照規定進行質量檢驗；合格的，憑醫生處方使用。
[Article 19] The drugs made up by medical treatment units must comply with clinical requirements and, in accordance with regulations, quality examinations must be conducted. They are only to be used if up to quality and on a doctor's prescription.

醫療單位配制的制劑不得在市場銷售。
Drugs made up by medical treatment units may not be sold on the market.

第二十條醫療單位購進藥品，必須執行質量驗收制度。
[Article 20] When a medical treatment unit purchases drugs, it must implement a system of checking the quality on delivery.

第五章藥品的管理
CHAPTER V DRUG ADMINISTRATION

第二十一條國家鼓勵研究、創制新藥。
[Article 21] The State encourages research into and development of new drugs.

研制新藥必須按照規定向國務院衛生行政部門或者省、自治區、直轄市衛生行政部門報送研制方法、質量指標、藥理及毒理試驗結果等有關資料和樣品。經批準后，方可進行臨床試驗或者臨床驗證。
Where a new drug has been researched and developed, in accordance with the regulations, a report must be submitted, with samples, to the State Council department administering health or the department of the province, autonomous region or municipality under the direct control of the Central Government administering health, giving details of the method of research and development, quality norms, pharmacological and toxicological tests and other relevant data. Only after it has been approved may clinical tests or clinical verifications be carried out.

完成臨床試驗或者臨床驗證并通過鑒定的新藥由國務院衛生行政部門批準發給證書。
Where a new drug has completed its clinical tests or clinical verification and has passed an appraisal it may be approved by the department of the State Council administering health, which will issue a certificate.

第二十二條生產新藥，必須經國務院衛生行政部門批準，并發給批準文號。但是，生產中藥飲片除外。
[Article 22] The production of new drugs must be approved by the department of the State Council administering health which will issue an approval number. However, the production of Chinese medicines sliced and prepared for decoction is excepted.

生產已有國家標準或者省、自治區、直轄市標準的藥品，必須經省、自治區、直轄市衛生行政部門征求同級藥品生產經營主管部門意見后審核批準，并發給批準文號。但是，生產中藥飲片除外。
The production of drugs for which there is already a national drug standard, or a drug standard of a province, autonomous region or municipality under the direct control of the Central Government, must be examined and approved by the department responsible for health administration in the relevant province, autonomous region or municipality under the direct control of the Central Government after seeking the opinion of the corresponding authority responsible for the drug-producing enterprise. An approval number will be issued. However, the production of Chinese medicines sliced and prepared for decoction is excepted.

第二十三條藥品必須符合國家藥品標準或者省、自治區、直轄市藥品標準。
[Article 23] Drugs must comply with the national drug standard, or with the drug standard of the province, autonomous region or municipality under the direct control of the Central Government.

國務院衛生行政部門頒布的《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 drug standards promulgated by the department of the State Council administering health are the national drug standards.

國務院衛生行政部門的藥典委員會負責組織國家藥品標準的制定和修訂。
The Pharmacopoeia Committee of the department of the State Council administering health is the body responsible for handling the setting and revision of national drug standards.

第二十四條國務院衛生行政部門和省、自治區、直轄市衛生行政部門可以成立藥品審評委員會，對新藥進行審評，對已經生產的藥品進行再評價。
[Article 24] The State Council department responsible for health administration and the departments of the provinces, autonomous regions and municipalities under the direct control of the Central Government administering health may establish a Drug Evaluation Committee to evaluate new drugs and re-evaluate drugs already being produced.

第二十五條國務院衛生行政部門對已經批準生產的藥品，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民健康的藥品，應當撤銷其批準文號。
[Article 25] The department of the State Council responsible for administering health shall organise investigation into drugs already approved for production; where the efficacy of a drug is not reliable, the side-effects to a drug are great, or a drug is for any other reason harmful to people's health, the approval number shall be revoked.

已被撤銷批準文號的藥品不得繼續生產、銷售；已經生產的由當地衛生行政部門監督銷毀或者處理。
Where the approval number of a drug has been revoked, production and sale of the drug may not be continued; what has already been produced shall be burnt or disposed of under the supervision of the local department administering health.

第二十六條禁止進口療效不確、不良反應大或者其他原因危害人民健康的藥品。
[Article 26] It is forbidden to import a drug if its efficacy is not reliable, if its side-effects are great, or it is for any other reason harmful to people's health.

第二十七條首次進口的藥品，進口單位必須提供該藥品的說明書、質量標準、檢驗方法等有關資料和樣品以及出口國（地區）批準生產的證明文件，經國務院衛生行政部門批準，方可簽訂進口合同。
[Article 27] Where a drug is being imported for the first time, the importing unit must submit a written description of the drug, details of its quality standards, testing and other relevant data, samples, and documentation proving that the exporting country (place) has approved production. Only when the approval of the department of the State Council administering health has been obtained may the import contract be signed.

第二十八條進口的藥品，必須經國務院衛生行政部門授權的藥品檢驗機構檢驗；檢驗合格的，方準進口。
[Article 28] Imported drugs must be examined by a drug examination body so authorised by the State Council department responsible for health administration. Only when a drug passes examination will importation be permitted.

醫療單位臨床急需或者個人自用進口的少量藥品按照海關的規定辦理進口手續。
The importation of a small amount of a drug to meet the urgent clinical needs of a medical treatment unit or for the personal use of an individual is to follow the importation procedures stipulated by Customs.

第二十九條對國內供應不足的中藥材、中成藥，國務院衛生行政部門有權限制或者禁止出口。
[Article 29] Where the supply of Chinese medicinal materials or prepared Chinese medicine is not sufficient for the Chinese domestic market, the State Council department responsible for health administration has the power to restrict or prohibit its export.

第三十條進口、出口麻醉藥品和國務院衛生行政部門規定范圍內的精神藥品，必須持有國務院衛生行政部門發給的《進口準許證》、《出口準許證》。
[Article 30] In order to import or export narcotic drugs or psychotropic drugs which come within the scope laid down by the department of the State Council administering health, it is necessary to hold an "Import Licence" or "Export Licence" issued by the department of the State Council administering health.

第三十一條新發現和從國外引種的藥材，經省、自治區、直轄市衛生行政部門審核批準后，方可銷售。
[Article 31] Medicinal materials which have been newly discovered or introduced from abroad may only be sold where they have been examined and approved by the department of the province, autonomous region or municipality under the direct control of the Central Government administering health.

第三十二條地區性民間習用藥材的具體管理辦法，由國務院衛生行政部門制定。
[Article 32] Detailed provisions for the administration of local customarily used folk medicines will be laid down by the State Council department responsible for health administration.

第三十三條禁止生產、銷售假藥。有下列情形之一的為假藥：
[Article 33] The production and sale of spurious drugs is prohibited. A drug is spurious if any one of the following circumstances exists:

（一）藥品所含成份的名稱與國家藥品標準或者省、自治區、直轄市藥品標準規定不符合的；
(1) The names of the ingredients contained in the drug do not correspond to the national drug standard or the drug standard set by the province, autonomous region or municipality under the direct control of the Central Government;

（二）以非藥品冒充藥品或者以他種藥品冒充此種藥品
(2) A substance that is not a drug is passed off as a drug, or one sort of drug is passed off as another drug.

有下列情形之一，藥品按假藥處理：
A drug will be treated as a spurious drug if one of the following circumstances exists:

（一）國務院衛生行政部門規定禁止使用的；
(1) The State Council department responsible for health administration has stipulated that its use is forbidden;

（二）未取得批準文號生產的；
(2) It was produced without first obtaining an approval number;

（三）變質不能藥用的；
(3) Due to deterioration, it cannot be used for medicinal purposes;

（四）被污染不能藥用的。
(4) Due to contamination, it cannot be used for medicinal purposes.

第三十四條禁止生產、銷售劣藥。有下列情形之一的藥品為劣藥：
[Article 34] It is forbidden to produce or sell inferior drugs. A drug is inferior if one of the following circumstances exists:

（一）藥品成份的含量與國家藥品標準或者省、自治區、直轄市藥品標準規定不符合的；
(1) The content of its ingredients does not comply with the national drug standard or the drug standard set by the province, autonomous region or municipality under the direct control of the Central Government;

（二）超過有效期的；
(2) Its period of efficacy has expired;

（三）其他不符合藥品標準規定的。
(3) It fails in any other way to comply with stipulated drug standards.

第三十五條藥品生產企業、藥品經營企業和醫療單位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污染藥品的疾病的患者，不得從事直接接觸藥品的工作。
[Article 35] Personnel of drug-producing enterprises, drug-handling enterprises and medical treatment units who come into direct contact with drugs must undergo a medical examination annually. Persons suffering from contagious diseases or any other disease that could contaminate drugs may not engage in work involving direct contact with drugs.

第六章藥品的包裝和分裝
CHAPTER VI THE PACKAGING AND REPACKAGING OF DRUGS

第三十六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。規定有效期的藥品，必須在包裝上注明有效期。
[Article 36] The packaging of drugs must be appropriate to the requirements of the quality of the drug and must facilitate their storage, transportation and use. Where a period of efficacy for a drug has been fixed, the period of efficacy must be clearly indicated on the package.

發運中藥材必須有包裝。每件包裝上必須注明品名、產地、日期、調出單位，并附有質量合格的標志。
Where Chinese medicinal materials are to be transported, they must be packaged. On each package, the name of the product, its place of origin, the date and the name of the dispatching unit must be clearly indicated and it must be marked to indicate that the quality is up to standard.

第三十七條藥品包裝必須按照規定貼有標簽并附有說明書。
[Article 37] Drug packages must, in accordance with regulations, be labelled and have an instruction booklet attached.

標簽或說明書上必須注明藥品的品名、規格、生產企業、批準文號、產品批號、主要成份、適應癥、用法、用量、禁忌、不良反應和注意事項。
The name of the drug, its specifications, the producing unit, approval number, product batch number, principal ingredients, diseases for which it is indicated, manner of use, side-effects and points to note must be clearly set out on the label or in the instruction booklet.

麻醉藥品、精神藥品、毒性藥品、放射性藥品和外用藥品的標簽必須印有規定標志。
The labels of narcotic drugs, psychotropic drugs, poisonous drugs, radioactive drugs and drugs for external use only must bear the prescribed mark.

第三十八條藥品經營企業分裝藥品，必須具有與所分裝藥品相適應的設施和衛生條件，由藥學技術人員負責，分裝記錄必須完整準確。
[Article 38] A drug-handling enterprise engaged in the repackaging of drugs must have equipment and hygienic conditions appropriate for the quantity of drugs repackaged. It must be under the charge of pharmaceutical technicians; records of the repackaging must be complete and precise.

分裝藥品必須附有說明書，在包裝上注明品名、規格、生產企業和產品批號、分裝單位和分裝批號。規定有效期的藥品，分裝后必須注明有效期。
An instruction booklet must be attached to a repackaged drug. The product name, specifications, name of the production unit and product batch number and of the repackaging unit and repackaging batch number shall be set out clearly on the package. Where a period of efficacy has been set for the drug, when it has been repackaged, the period of efficacy must be clearly indicated.

第七章特殊管理的藥品
CHAPTER VII DRUGS UNDER SPECIAL CONTROL

第三十九條國家對麻醉藥品、精神藥品、毒性藥品、放射性藥品，實行特殊的管理辦法。管理辦法由國務院制定。
[Article 39] The State imposes special controls on narcotic drugs, psychotropic drugs, poisons and radioactive drugs. The controls will be stipulated by the State Council.

第四十條麻醉藥品，包括原植物，只準由國務院衛生行政部門會同有關部門指定的單位生產，并由省、自治區、直轄市衛生行政部門會同有關部門指定的單位按照規定供應。
[Article 40] The production of narcotic drugs, including the original plant, may only be undertaken by units appointed to do so by the department of the State Council administering health and relevant departments acting jointly, and supply may only be undertaken by units appointed by the department of the province, autonomous region or municipality under the direct control of the Central Government administering health and the relevant departments acting jointly.