For BLAs, PLAs, and their supplements, the analytical procedures and their validation are submitted as part of the license application or supplement and are evaluated by the review committee.

 
  • 對于BLA,PLA及它們的補充,在所提交的許可證申請中應當要有分析方法和方法驗證這部分的資料,審評委員會(huì )會(huì )對這部分資料進(jìn)行評審。
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