1
20240724关于公开征求《发酵或半合成化学仿制药抗生素有关物质限度制定指导原则（征求意见稿）》意见的通知。
https://www.cde.org.cn/main/news/viewInfoCommon/d2d425de57afa38a01b03dafb1e0ed00
2
20240724关于公开征求《化药口服固体制剂中间产品/待包装产品存放时限研究技术指导原则（征求意见稿）》意见的通知。
https://www.cde.org.cn/main/news/viewInfoCommon/a657de5ebe0a5a1c9ba216871355e169
3
20240725关于公开征求《模型引导的创新药物剂量探索和优化技术指导原则(征求意见稿）》意见的通知。
https://www.cde.org.cn/main/news/viewInfoCommon/efd1f4faac2a5cbecc147c2e98a76361
4
20240725关于公开征求《多糖结合疫苗质量控制技术指导原则（征求意见稿）》意见的通知。
https://www.cde.org.cn/main/news/viewInfoCommon/a96ebafaa89c587181ca7d93023cdc4b
5
20240726关于公开征求《已上市化药药品补充申请药学自评估报告（原料药/制剂）（征求意见稿）》意见的通知。
https://www.cde.org.cn/main/news/viewInfoCommon/069a7f3a8025549cf68c314da63c12b5
1
20240723 Draft Guidance: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers | FDA
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postapproval-manufacturing-changes-biosimilar-and-interchangeable-biosimilar-products-questions-and
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20240725 Guidance for Industry: Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products | FDA
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-electronic-health-records-and-medical-claims-data-support-regulatory
1
20240722 Draft guideline on the development and manufacture of oligonucleotides: Guideline on the Development and Manufacture of Oligonucleotides (europa.eu)
https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-development-manufacture-oligonucleotides_en.pdf
2
20240724 Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products | European Medicines Agency (EMA) (europa.eu)
https://www.ema.europa.eu/en/concept-paper-development-guideline-demonstration-therapeutic-equivalence-nasal-products
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20240725 Draft guideline on the chemistry of active substances - Revision 1: Guideline on the chemistry of active substances (europa.eu)
https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-chemistry-active-substances-revision-1_en.pdf
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20240726 Product-specific bioequivalence guidance: Draft: Tolvaptan - product-specific bioequivalence (europa.eu)
https://www.ema.europa.eu/en/documents/scientific-guideline/tolvaptan-tablets-dose-range-75-15-30-mg-tolvaptan-tablets-dose-range-15-30-45-60-90-mg-product-specific-bioequivalence-guidance_en.pdf
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