第九十五条 药品监督管理部门或者其设置的药品检验机构或者其确定的专业从事药品检验的机构参与药品生产经营活动的，由其上级机关或者监察机关责令改正，有违法收入的予以没收；情节严重的，对直接负责的主管人员和其他直接责任人员依法给予行政处分。
Article 95 If a pharmaceutical supervisory and administrative department, or an inspection institution it has established, or an organization exclusively engaged in pharmaceutical inspection it has appointed, participates in the production and trade of pharmaceuticals, the responsible authority of a higher level or a supervisory organization shall order it to amend itself and have its unlawful income confiscated.
If the circumstances are serious, the directly liable person in charge and other responsible personnel shall be subject to administrative sanctions.
药品监督管理部门或者其设置的药品检验机构或者其确定的专业从事药品检验的机构的工作人员参与药品生产经营活动的，依法给予行政处分。
If a staff member in a pharmaceutical supervisory and administrative department, or in an inspection institution it has established, or in an organization exclusively engaged in pharmaceutical inspection it has appointed, participates in the production and trade of pharmaceuticals, he or she shall be subject to administrative sanction.
第九十六条 药品监督管理部门或者其设置、确定的药品检验机构在药品监督检验中违法收取检验费用的，由政府有关部门责令退还，对直接负责的主管人员和其他直接责任人员依法给予行政处分。
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.
对违法收取检验费用情节严重的药品检验机构，撤销其检验资格。
Article 96 If a pharmaceutical supervisory and administrative department or a pharmaceutical inspection institution it has established or appointed unlawfully collects inspection fees during a pharmaceutical supervision and inspection, it shall be ordered by the government bodies concerned to make reimbursements, and the directly liable person and other responsible personnel shall be subject to administrative sanctions.
If the circumstances are serious, the certificate of qualification of the inspection institution which has unlawfully collected inspection fees shall be revoked.
第九十七条 药品监督管理部门应当依法履行监督检查职责，监督已取得《药品生产许可证》、《药品经营许可证》的企业依照本法规定从事药品生产、经营活动。
Article 97 A pharmaceutical supervisory and administrative department shall perform its duty of supervision and inspection according to laws and regulations, and shall supervise the production and trade of the enterprises which have obtained a Pharmaceutical Production License or a Pharmaceutical Trade License according to the regulations of this Law.
已取得《药品生产许可证》、《药品经营许可证》的企业生产、销售假药、劣药的，除依法追究该企业的法律责任外，对有失职、渎职行为的药品监督管理部门直接负责的主管人员和其他直接责任人员依法给予行政处分；构成犯罪的，依法追究刑事责任。
If an enterprise which has obtained a Pharmaceutical Production License or a Pharmaceutical Trade License produces and sells fake medicines and medicines of inferior quality, the enterprise shall be investigated for legal liabilities according to laws and regulations.
In addition, the directly liable person in charge and other responsible personnel in the pharmaceutical supervisory and administrative department who have neglected or have been derelict in their duty shall be subject to administrative sanction.
If a crime is constituted, the party shall be investigated for criminal liabilities according to laws and regulations.
第九十八条 药品监督管理部门对下级药品监督管理部门违反本法的行政行为，责令限期改正；逾期不改正的，有权予以改变或者撤销。
Article 98 A pharmaceutical supervisory and administrative department shall, within a prescribed time limit, order a pharmaceutical supervisory and administrative department of a lower level to correct an administrative act which is not in conformity with this Law.
If the administrative act is not corrected within the prescribed time limit, the department shall have the power to change or repeal it.
第九十九条 药品监督管理人员滥用职权、徇私舞弊、玩忽职守，构成犯罪的，依法追究刑事责任；尚不构成犯罪的，依法给予行政处分。
Article 99 If the personnel of the pharmaceutical supervision and administration misuse their authority, engage in irregular practices due to favoritism, or neglect their duties to such an extent that a crime is constituted, they shall be investigated for criminal liabilities.
If their acts have not constituted a crime, they shall be subject to administrative sanctions.
第一百条 依照本法被吊销《药品生产许可证》、《药品经营许可证》的，由药品监督管理部门通知工商行政管理部门办理变更或者注销登记。
Article 100 If a Pharmaceutical Production License or a Pharmaceutical Trade License is revoked according to this Law, the pharmaceutical supervisory and administrative department shall notify the industry and commerce administrative department to alter or annul the registration.
第一百零一条 本章规定的货值金额以违法生产、销售药品的标价计算；没有标价的，按照同类药品的市场价格计算。
Article 101 The value of goods as prescribed in this chapter is designated according to the marked price of the unlawfully made or sold medicines.
In the absence of a marked price, the value of goods shall be designated according to the market price of pharmaceuticals of the same kind.
第一百零二条 本法下列用语的含义是：
Article 102 For the purpose of this Law, the following definitions are offered:
药品，是指用于预防、治疗、诊断人的疾病，有目的地调节人的生理机能并规定有适应症或者功能主治、用法和用量的物质，包括中药材、中药饮片、中成药、化学原料药及其制剂、抗生素、生化药品、放射性药品、血清、疫苗、血液制品和诊断药品等。
Pharmaceuticals means the articles intended for use in the prevention, treatment or diagnosis of human diseases, or intended to effect the purposive regulation of human physiological functions, for which indications or major functions, usage and dosage are prescribed.
They include raw traditional Chinese medicinal materials, traditional medicines prepared in ready-to-use forms, and other prepared Chinese medicines, medicinal chemicals and their preparations, antibiotics, biochemical medicines, radioactive drugs, serums, vaccines, blood products, diagnostic aids, etc.
辅料，是指生产药品和调配处方时所用的赋形剂和附加剂。
Supplementary materials means the excipients and additives used for the production and dispensing of pharmaceuticals.
药品生产企业，是指生产药品的专营企业或者兼营企业。
Pharmaceutical producing enterprise means an enterprise exclusively or partly engaged in the production of pharmaceuticals.
药品经营企业，是指经营药品的专营企业或者兼营企业。
Pharmaceutical trading enterprise means an enterprise exclusively or partly engaged in the trade of pharmaceuticals.
第一百零三条 中药材的种植、采集和饲养的管理办法，由国务院另行制定。
Article 103 Measures for the control of cultivation, collection and breeding of all categories of medicinal materials used in traditional Chinese medicine shall be seperately formulated by the State Council .
第一百零四条 国家对预防性生物制品的流通实行特殊管理。
Article 104 The State Council shall formulate detailed measures to carry out special control on the circulation of preventive bioproducts.
具体办法由国务院制定。
Article 104 The State Council shall formulate detailed measures to carry out special control on the circulation of preventive bioproducts.
第一百零五条 中国人民解放军执行本法的具体办法，由国务院、中央军事委员会依据本法制定。
Article 105 Detailed measures for the implementation of this law by the Chinese People's Army shall be formulated by the State Council and the Central Military Committee of the State on the basis of this Law.
中华人民共和国药品管理法
LAW OF THE PEOPLE'S REPUBLIC OF CHINA ON THE ADMINISTRATION OF DRUGS
第一条为加强药品监督管理，保证药品质量，增进药品疗效，保障人民用药安全，维护人民身体健康，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.
第二条国务院卫生行政部门主管全国药品监督管理工作。
[Article 2] The State Council department responsible for health administration is the body in charge of national drug control and administration.
第三条国家发展现代药和传统药，充分发挥其在预防、医疗和保健中的作用。
[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.
国家保护野生药材资源 鼓励培育中药材。
The State safeguards resources of uncultivated medicinal materials and encourages the cultivation of raw materials used for traditional Chinese medicines.