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请问下各位老师，化药3，4，5.2类，2.3.R和3.2R区域性信息提供哪些？2.3.A和3.2.A提供哪些资料？

M4Q R1模块2的质量综述及模块3质量

...R HUMAN USE: QUALITY – M4Q(R1)QUALITY OVERALL SUMMARY OF MODULE 2 MODULE 3 : QUALITY  Current Step 4 version dated 12 September 2002         This Guideline has been developed by the appropriate ICH Expert Working Group and    &n...

行业指南 M4Q CTD-质量

...sion of Drug Information HFD-240 5600 Fishers LaneRockville, MD 20857(Tel) 301-827-4573(Internet) http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance, HFM-40Center for Biologics Evaluation and Research Food and Drug Administration1401 Roc...

各位老师 3.2.A、2.3.A 是不是生物制品要提供的信息？还是化药也要提供？

M4Q 执行工作组：问与答(R1)

...ions & Answers (R1)   Current version dated July 17, 2003     In order to facilitate the implementation of the CTD Quality (M4Q) guideline, the ICH Experts have developed a series of Q&As:In November 2005, the ICH Steering Committee adopted a new codif...

请问原料药登记资料按照M4写，把3.2.R和3.2.A也放进去吗？

2019年直接转为A的原料药，没有提交过基线资料，现在与制剂关联，原料药3.2.S部分可以只交3.2.S.4原料药的质量控制部分么，还是需要3.2.S.1-3.2.S.7所有的资料？

化药3类IND申请不用交2.3.A.1吗？

巴西药品注册

...要求内容1.法规文件1.1注册申请表1.2 现场检查付费原件1.3 公司营业执照复印件1.4 公司商业授权复印件1.5 公司特殊商业授权复印件，如有特殊控制物质时1.6 ANVISA颁发的产品生产线符合GMP证书复印件1.7 如必要，进口产品时进口商...

M4 R4人用药物注册申请的通用技术文件组织结构

... has been revised at the Steering Committee held in Osaka, November 11, 2003 and has been corrected on January 13, 2004 : The table for Module 2 has a row for 2.3.S.7 added)(The Annex: Granularity Document has been adopted at the Assembly meeting on June 15, 2016 to add Module 2 and 3 tables and App...