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The active substance manufacturer's restricted ("closed" part of the EDMF should follow thestructure of Module 3.2.S of the CTD. A separate Quality Overall Summary for the information included in the active substance manufacturer's restricted ("closed" part shouldalso be provided, as part of the EDMF. 这一段是不是说明CTD中至少是欧洲的制剂申报,除了授权信以外,还是需要原料药DMF的公开部分文件和非公开部分文件了啊,不是说不用非公开的部分吗, |
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2楼2007-03-04 19:00:57
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zhoudingcheng
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