权威医学用药书籍速查系统

4. CONSIDERATIONS FOR IMPLEMENTATION

When sponsors or manufacturers change their existing methods to the implemented Q4B-evaluated pharmacopoeia texts that are referenced in Section 2.1 of this annex , any change notification , variation .And/or prior approval procedures should be handled in accordance with established regiona regulatory mechanisms pertaining to compendial changes .Details of implementation requirements will be provided in the notification by MHLW when this annex is implemented .

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——《2011药品注册的国际技术要求.质量部分》
书名:《2011药品注册的国际技术要求.质量部分》
栏目:2011药品注册的国际技术要求.质量部分 > EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: TEST FOR SPECIFIED MICRO-ORGANISMS GENERAL CHAPTER Q4B ANNEX 4B(R1) > EVALUATION AND RECOMMENDATION OF PHARMACOPOEI
作者:美国ICH指导委员会 周海钧
参编:王执,王知坚,匡荣,李洋,张洁
页码:321-322
版本:1
出版时间:2011-01-01
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