T/SDHCST 004-2023
Animal Species and Model Selection for Non-clinical Studies of the Cell Therapy Medical Products (English Version)

Standard No.

T/SDHCST 004-2023

Language

Chinese, Available in English version

Release Date

2023

Published By

Group Standards of the People's Republic of China

Latest

T/SDHCST 004-2023

Scope

This standard specifies and clarifies the appropriate relevant species for cell therapy product safety assessment research, helps to learn more about the potential in vivo toxicity of cell therapy products, and is suitable for the selection of animal species and models for cell therapy products.

T/SDHCST 004-2023 history

• 2023 T/SDHCST 004-2023 Animal Species and Model Selection for Non-clinical Studies of the Cell Therapy Medical Products
• 2022 T/SDHCST 004-2022 Technical Specification for Artificially Induced Pluripotent Stem Cells
• 2021 T/SDHCST 004-2021 Technical conditions and requirements for human umbilical cord/placental mesenchymal stem cell products
• 2019 T/SDHCST 004-2019 CTCs Testing and Consultation Center Regulations
• 2018 T/SDHCST 004-2018 Standards for the storage and configuration of Medicines in Well-off level Township Hospitals