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.

完成临床试验或者临床验证并通过鉴定的新药由国务院卫生行政部门批准发给证书。

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.

第二十二条生产新药，必须经国务院卫生行政部门批准，并发给批准文号。但是，生产中药饮片除外。

[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.

生产已有国家标准或者省、自治区、直辖市标准的药品，必须经省、自治区、直辖市卫生行政部门征求同级药品生产经营主管部门意见后审核批准，并发给批准文号。但是，生产中药饮片除外。

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.

第二十三条药品必须符合国家药品标准或者省、自治区、直辖市药品标准。

[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.

国务院卫生行政部门颁布的《中华人民共和国药典》和药品标准，为国家药品标准。

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.

国务院卫生行政部门的药典委员会负责组织国家药品标准的制定和修订。

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.

第二十四条国务院卫生行政部门和省、自治区、直辖市卫生行政部门可以成立药品审评委员会，对新药进行审评，对已经生产的药品进行再评价。

[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.

第二十五条国务院卫生行政部门对已经批准生产的药品，应当组织调查；对疗效不确、不良反应大或者其他原因危害人民健康的药品，应当撤销其批准文号。

[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.

已被撤销批准文号的药品不得继续生产、销售；已经生产的由当地卫生行政部门监督销毁或者处理。

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.

第二十六条禁止进口疗效不确、不良反应大或者其他原因危害人民健康的药品。

[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.

第二十七条首次进口的药品，进口单位必须提供该药品的说明书、质量标准、检验方法等有关资料和样品以及出口国（地区）批准生产的证明文件，经国务院卫生行政部门批准，方可签订进口合同。

[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.

第二十八条进口的药品，必须经国务院卫生行政部门授权的药品检验机构检验；检验合格的，方准进口。

[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.

医疗单位临床急需或者个人自用进口的少量药品按照海关的规定办理进口手续。

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.

第二十九条对国内供应不足的中药材、中成药，国务院卫生行政部门有权限制或者禁止出口。

[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.

第三十条进口、出口麻醉药品和国务院卫生行政部门规定范围内的精神药品，必须持有国务院卫生行政部门发给的《进口准许证》、《出口准许证》。

[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.

第三十一条新发现和从国外引种的药材，经省、自治区、直辖市卫生行政部门审核批准后，方可销售。

[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.

第三十二条地区性民间习用药材的具体管理办法，由国务院卫生行政部门制定。

[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.

第三十三条禁止生产、销售假药。有下列情形之一的为假药：

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