Regulation&Guideline（China）-中国细胞治疗行业相关法规指南-Hillgene

Regulation&Guideline（China）

2023-01-17

谱新生物Hillgene

Regulation&Guideline（China）
No	Regulation&Guideline	Issued by	Release time	Download
01	Technical Guideline for the Research of Human Cell Therapy and the Quality Control of Drug Products	CDE	2003/3/20	doc
02	Considerations on “IND Application Studies and Application Materials for Cellular Therapy Products”	CDE	2018/3/13	doc
03	Technical Guideline for the Clinical Trial of Cellular Therapy Products Based on the Human Stem Cell and its derivatives (Draft for Comments)	CDE	2020/8/24	docx
04	Technical Guideline for the Pharmaceutical Study and Evaluation of Gene Therapy Products (Draft for Comments)	CDE	2020/9/14	pdf
05	Technical Guideline for the Pharmaceutical Study and Evaluation of Cell-Based Immunotherapy Products (Draft for Comments)	CDE	2020/9/30	pdf
06	Technical Guideline for the Pharmaceutical Study and Evaluation of Genetic Transduction and Modification System (Draft for Comments)	CDE	2020/9/30	pdf
07	Technical Guideline for the Clinical Trial of Cell-based Immunotherapy Products	CDE	2021/2/10	pdf
08	Technical Guideline for the Pharmaceutical Study and Evaluation of HSC(Human Stem Cell)-Based Products (Draft for Comments)	CDE	2021/8/17	pdf
09	Technical Guideline for the Non-clinical Study and Evaluation of Gene Therapy Products (Interim)	CDE	2021/12/3	pdf
10	Technical Guideline for the Non-clinical Study of Gene-Modified Cellular Therapy Products (Interim)	CDE	2021/12/3	pdf
11	Technical Guideline for the Clinical Long-Term Follow-up Study (Interim)	CDE	2021/12/3	pdf
12	Technical Guideline for the Clinical Risk Management Plan for Marketing Application of Chimeric Antigen Receptor T cell (CAR-T) Therapy Products	CDE	2022/1/29	pdf
13	Technical Guideline for the Pharmaceutical Study and Evaluation of Cell-based Immunotherapy Products (Interim)	CDE	2022/5/31	pdf
14	Technical Guideline for the Pharmaceutical Study and Evaluation of In-vivo Gene Therapy Products (Interim)	CDE	2022/5/31	pdf
15	Technical Guideline for the Pharmaceutical Study and Evaluation of Ex-vivo Genetic Modification System (Interim)	CDE	2022/5/31	pdf
16	Administrative Measures for Clinical Trials of Stem Cells (Interim)	NMPA 国家卫生计生委	2015/7/20	doc
17	Guidelines on the Quality Control and Preclinical Research of Drug Products Based on Stem Cells (Interim)	NMPA 国家卫生计生委	2015/7/31	doc
18	Technical Guideline for the Research and Evaluation of Cellular Therapy Products (Interim)	NMPA 国家卫生计生委	2017/12/22	docx
19	Good Manufacturing Practice (GMP) – Appendix for Cellular Therapy Drugs (Draft for Comments)	NMPA 国家卫生计生委	2022/1/6	docx
20	Good Manufacturing Practice (GMP) – Appendix for Cellular Therapy Drugs (Draft for Comments)	CFDI	2019/11/28	docx
21	Good Manufacturing Practice for Cellular Therapy Products (Interim)	CFDI	2022/10/31	doc
22	CAR-T Cell Quality Control Testing Research and Non-clinical Study Considerations	中检院 NIFDC	2018/6/5	pdf
23	Regulations on the Hematopoietic Stem Cell Transplantation	国家卫健委	2017/2/17	docx
24	Regulations on the Clinical Use of the New Techniques in Biomedicine Studies (Draft for Comments)	国家卫健委	2019/2/26	docx
25	Administrative Measures for the Clinical Research and Translational Use of Somatic Cell Therapy (Interim) (Draft for comment)	国家卫健委	2019/3/29	doc
26	Regulations on the Transplantation of Hematopoietic Stem Cell Obtained from the Blood of the Umbilical Cord (Interim)	国家卫健委	2019/6/10	doc
27	Proclamation of the General Instructions on Human Gene Therapy Products	国家药典委员会 ChPC	2019/6/10	pdf
28	Proclamation of the Regulations on Microbial Testing Method of Cell-Based Products (Draft)	国家药典委员会 ChPC	2021/10/26	pdf
29	Guideline for the Bioassay of Gene-Modified Cell Line	国家药典委员会 ChPC	2021/12/14	pdf
30	Regulations on Manufacturing Quality Management for Chimeric Antigen Receptor T Cell (CAR-T cell)-based Drug Products	中国医药生物技术协会 CMBA	2018/8/29	pdf
31	Regulations on Supervision and Administration of Autogenous Chimeric Antigen Receptor T Cell (CAR-T cell)-based Drug Products (Interim Regulations in Shanghai)	上海市药监局	2022/7/19	pdf
32	Validation Technical Requirements for Rapid Sterility Testing Method of Cellular and Gene Therapy Products	上海医药行业协会	2022/7/28	docx

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