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IBDC創新生物製造整合技術運用藥物研發聯盟專區

審查觀點及法規文章

不定期整理國內外與創新生物製造整合技術運用藥物研發相關之審查觀點及法規文章

序號	標題名稱	刊登日期
1	ICH Q13 CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS	2024-06-27
2	Considerations for Development of Chimeric Antigen Receptor (CAR) T Cell Products-Draft Guidance for Industry	2024-06-27
3	Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases: regulatory considerations	2024-06-27
4	WHO-Guidelines on the quality, safety and efficacy of plasmid DNA vaccines	2024-06-27
5	ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin	2025-01-16
6	Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products-Draft Guidance for Industry	2025-01-16
7	Potency Assurance for Cellular and Gene Therapy Products-Draft Guidance for Industry	2025-01-16
8	Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry	2025-01-16
9	Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions- Guidance for Industry and Food and Drug Administration Staff	2025-03-25
10	Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products- Draft Guidance for Industry	2025-03-25

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