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Building 4, Yuewang Wisdom Valley, 1463 Wuzhong Avenue, Wuzhong District, Suzhou, China

400-900-1882

bd@hillgene.com

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刚刚！NMPA发布“实施药品注册申请电子申报”公告！

NMPA issued the Announcement on “Implementing Electronic Application of Drug Registration”

MAH落实药品质量主体责任监督管理规定（征求意见稿）发布

MAH issued“Provisions for Supervision and Administration of Drug Quality (Interim)”

【重磅】细胞治疗产品生产质量管理指南（试行）发布！

Big News: Newly released “Good Manufacturing Practice for Cellular Therapy Products (Interim)”!

重磅：FDA最新发布“CMC批准后变更可比性方案”指南正式稿

Big News: FDA issued the finalized version of guidance “Comparability Protocols for Post-approval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA”

CDE:关于公开征求《慢性淋巴细胞白血病新药临床研发技术指导原则（征求意见稿）》意见的通知

CDE: Notification of Public Comment Soliciting on “Technical Guideline for the Clinical Research and Development of New Drug Products for Chronic Lymphocytic Leukemia (Draft for Comments)”

CDE重磅发布！《中国新药注册临床试验进展年度报告（2021年）》

Important Report from CDE! The Annual Report on Progress of Clinical Trials for New Drug Registration in China (2021)

CDE发布《罕见疾病药物临床研究统计学指导原则（试行）》

CDE issued “Guidelines on Clinical Trial Statistics of Drug Products for Rare Diseases (Interim)”

国家药监局药审中心关于发布《体内基因治疗产品药学研究与评价技术指导原则（试行）》的通告（2022年第31号）

Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of In-vivo Gene Therapy Products (Interim)” (No. 31, 2022)

国家药监局药审中心关于发布《免疫细胞治疗产品药学研究与评价技术指导原则（试行）》的通告（2022年第30号）

Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of Cell-based Immunotherapy Products (Interim)” (No. 30, 2022)

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Nucleic Acid (Plasmid/mRNA)

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Lentiviral Vectors

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Jiangsu Hillgene Biopharma Co.,Ltd

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400-900-1882

Building 4, Yuewang Wisdom Valley, 1463 Wuzhong Avenue, Wuzhong District, Suzhou, China

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By：UCI