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 | 2015/7/20 | doc |
| 17 | Guidelines on the Quality Control and Preclinical Research of Drug Products Based on Stem Cells (Interim) | NMPA | 2015/7/31 | doc |
| 18 | Technical Guideline for the Research and Evaluation of Cellular Therapy Products (Interim) | NMPA | 2017/12/22 | docx |
| 19 | Good Manufacturing Practice (GMP) – Appendix for Cellular Therapy Drugs (Draft for Comments) | NMPA | 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 | NIFDC | 2018/6/5 | pdf |
| 23 | Regulations on the Hematopoietic Stem Cell Transplantation | NHC | 2017/2/17 | docx |
| 24 | Regulations on the Clinical Use of the New Techniques in Biomedicine Studies (Draft for Comments) | NHC | 2019/2/26 | docx |
| 25 | Administrative Measures for the Clinical Research and Translational Use of Somatic Cell Therapy (Interim) (Draft for comment) | NHC | 2019/3/29 | doc |
| 26 | Regulations on the Transplantation of Hematopoietic Stem Cell Obtained from the Blood of the Umbilical Cord (Interim) | NHC | 2019/6/10 | doc |
| 27 | Proclamation of the General Instructions on Human Gene Therapy Products | ChPC | 2019/6/10 | pdf |
| 28 | Proclamation of the Regulations on Microbial Testing Method of Cell-Based Products (Draft) | ChPC | 2021/10/26 | pdf |
| 29 | Guideline for the Bioassay of Gene-Modified Cell Line | ChPC | 2021/12/14 | pdf |
| 30 | Regulations on Manufacturing Quality Management for Chimeric Antigen Receptor T Cell (CAR-T cell)-based Drug Products | 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) | Shanghai Food and Drug Administration | 2022/7/19 | pdf |
| 32 | Validation Technical Requirements for Rapid Sterility Testing Method of Cellular and Gene Therapy Products | Shanghai Pharmaceutical Industry Association | 2022/7/28 | docx |
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