drug approval number

基本解釋

The Approval Letter of Supplementary Application and a drug approval number will be issued for qualified application.
符合規(guī)定的，發(fā)給《藥品補(bǔ)充申請(qǐng)批件》及藥品批準(zhǔn)文號(hào)。
Methods:The quality management were strengthened through three measures: quality standard, drug approval number and GMP management.
方法：從中藥飲片的質(zhì)量標(biāo)準(zhǔn)、批準(zhǔn)文號(hào)管理和GMP管理三方面來(lái)加強(qiáng)中藥飲片的質(zhì)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.
轉(zhuǎn)讓方僅獲得《新藥證書(shū)》的，對(duì)照藥品的選擇應(yīng)當(dāng)按照《藥品注冊(cè)管理辦法》的規(guī)定及有關(guān)技術(shù)指導(dǎo)原則執(zhí)行。