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審查觀點及法規文章

刊登日期：2023-03-06  |  點閱次數 : 5032 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https://www.cde.org.tw/Content/ebook/FlippingBook%20Files/RMV134/RMV134all/2/index.html#zoom=z
 
•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
 
•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
 
•醫藥品查驗中心:CART製劑臨床長期安全性追蹤考量重點
 
•醫藥品查驗中心:確認性臨床試驗次群體研究之指導原則

國外：

•ICH Q13 CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS
 
•Considerations for Development of Chimeric Antigen Receptor (CAR) T Cell Products Guidance for Industry
 
•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
 
•ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
 
•Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products-Draft Guidance for Industry
 
•Potency Assurance for Cellular and Gene Therapy Products-Draft Guidance for Industry
 
•Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry

 


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