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.

第二章药品生产企业的管理

CHAPTER II ADMINISTRATION OF DRUG-PRODUCING ENTERPRISES

第四条开办药品生产企业必须由所在省、自治区、直辖市药品生产经营主管部门审查同意，经所在省、自治区、直辖市卫生行政部门审核批准，并发给《药品生产企业许可证》。

[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".

无《药品生产企业许可证》的工商行政管理部门不得发给《营业执照》。

 Without a "Drug-production Enterprise Licence", the department administering industry and commerce may not issue a "Business Licence".

《药品生产企业许可证》应当规定有效期，到期重新审查发证。具体办法由国务院卫生行政部门规定。

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.

第五条开办药品生产企业必须具备以下条件：

[Article 5] The establishment of an enterprise to produce drugs must satisfy the following conditions:

（一）具有与所生产药品相适应的药师或者助理工程师以上技术人员及技术工人。

(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.

中药饮片加工企业没有药师或者助理工程师以上技术人员，配备熟悉药性并经县级以上卫生行政部门审查登记的药工人员。

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）具有与所生产药品相适应的厂房、设施和卫生环境。

(2) It must have a factory building, facilities and a hygienic environment appropriate to its production of drugs.

（三）具有能对所生产药品进行质量检验的机构或者人员以及必要的仪器设备。

(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.

第六条药品必须按照工艺规程进行生产，生产记录必须完整准确。

[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.

中药饮片的炮制必须符合《中华人民共和国药典》,或者省、自治区、直辖市卫生行政部门制定的《炮制规范》的规定。

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.

第七条生产药品所需的原料、辅料以及直接接触药品的容器和包装材料，必须符合药用要求。

[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.

第八条药品出厂前必须经过质量检验；不符合标准的，不得出厂。

[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.

第九条药品生产企业必须按照国务院卫生行政部门制定的《药品生产质量管理规范》的要求，制定和执行保证药品质量的规章制度和卫生要求。

[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.

第三章药品经营企业的管理

CHAPTER III ADMINISTRATION OF DRUG-HANDLING ENTERPRISES

第十条开办药品经营企业必须由所在地药品生产经营主管部门审查同意，经县级以上卫生行政部门审核批准，并发给《药品经营企业许可证》。无《药品经营企业许可证》的，工商行政管理部门不得发给《营业执照》。

[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".

《药品经营企业许可证》应当规定有效期，到期重新审查发证。具体办法由国务院卫生行政部门规定。

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