法规指南
CDMO服务 / 法规指南
1.人用基因治疗制品总论草案
2.CAR-T细胞治疗产品质量控制检测研究及非临床评价考虑要点
3.细胞治疗产品研究与评价技术指导原则（试行）
4.细胞治疗产品申请临床试验药学研究和申报资料的考虑要点CDE
5.Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
6.Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) Draft Guidance for Industry
7.Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up Draft Guidance for Industry
