中华人民共和国药品管理法(双语)(8)

作者:admin

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2014-2-28 10:57

第十九条医疗单位配制的制剂,必须根据临床需要并按照规定进行质量检验;合格的,凭医生处方使用。
[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.

医疗单位配制的制剂不得在市场销售。
Drugs made up by medical treatment units may not be sold on the market.

第二十条医疗单位购进药品,必须执行质量验收制度。
[Article 20] When a medical treatment unit purchases drugs, it must implement a system of checking the quality on delivery.

第五章药品的管理
CHAPTER V DRUG ADMINISTRATION

第二十一条国家鼓励研究、创制新药。
[Article 21] The State encourages research into and development of new drugs.

研制新药必须按照规定向国务院卫生行政部门或者省、自治区、直辖市卫生行政部门报送研制方法、质量指标、药理及毒理试验结果等有关资料和样品。经批准后,方可进行临床试验或者临床验证。
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.