• The approval Letter of Supplementary application and a drug approval number will be issued for qualified application.

    符合规定发给药品补充申请批件》药品批准文号

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  • Methods: the quality management were strengthened through three measures: quality standard, drug approval number and GMP management.

    方法:从中药饮片的质量标准批准文号管理GMP管理方面加强中药饮片的质量管理。

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  • In case the transferor did not obtain a drug approval number, the reference drug shall be selected in accordance with the drug Registration Regulation and relevant technical guidelines.

    转让方获得新药证书》的,对照药品选择应当按照《药品注册管理办法》规定有关技术指导原则执行

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  • A drug manufacturer may produce the drug only after an approval number is granted to it.

    药品生产企业取得药品批准文号后,方可生产该药品。

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  • A drug manufacturer is permitted to produce the drug only after an approval number has been granted to it.

    药品生产企业取得药品批准文号后,方可生产药品。

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  • This takes account of the number of countries in which a company wins approval for a new drug, weighted by the size of each country's market.

    考虑到了允许一家公司新药本国上市国家数量,并依照每个国家的市场规模权衡其重要性。

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  • Article 4 the Ministry of Agriculture shall be responsible for the work of issuing and supervising the approval document number of veterinary drug products of the whole country.

    第三条兽药生产企业生产兽药,应当取得农业部核发产品批准文号。

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  • Article 3 a veterinary drug production enterprise shall obtain the product approval document number as is issued by the Ministry of Agriculture for the production of veterinary drugs.

    第三兽药生产企业生产兽药,应当取得农业部核发产品批准文号。

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  • Article 2 the present Measures shall be applicable to the application for, issue of and supervision over the approval document number of veterinary drug products.

    第二兽药产品批准文号申请核发监督管理适用办法

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  • Article 2 the present Measures shall be applicable to the application for, issue of and supervision over the approval document number of veterinary drug products.

    第二兽药产品批准文号申请核发监督管理适用办法

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