中华人民共和国药品管理法(双语)(9)

作者:admin

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2014-3-3 09:26

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.