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審查觀點及法規文章

刊登日期:2023-03-06  |  點閱次數 : 4476 次 

國內:

•當代醫藥月刊: COVID-19 mRNA疫苗之化學製造管制法規研究
醫藥品查驗中心脂質奈米粒包覆mRNA疫苗類型產品 ─ 於CMC放行規格檢測項目與適合的分析方法考量

https://www.cde.org.tw/knowledge/knowledge_more?id=1891

醫藥品查驗中心: 細胞治療製劑製程中使用自動化系統之法規科學

https://www.cde.org.tw/knowledge/knowledge_more?id=1945.

醫藥品查驗中心: 藥品可浸出物及可滲出物之研發策略指導原則

 

國外:

•ICH Q13 CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS
https://database.ich.org/sites/default/files/ICH_Q13_Step4_Guideline_2022_1116.pdf
•Considerations for Development of Chimeric Antigen Receptor (CAR) T Cell Products-Draft Guidance for Industry
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-development-chimeric-antigen-receptor-car-t-cell-products
•Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases: regulatory considerations
https://cdn.who.int/media/docs/default-source/biologicals/vaccine-standardization/annex-3---mrna-vaccines_who_trs_1039_web-2.pdf?sfvrsn=6e31a112_1&download=true
WHO-Guidelines on the quality, safety and efficacy of plasmid DNA vaccines