T/SDHCST 001-2023
General Principles on the Non-Clinical Studies of the Cell Therapy Medical Products (English Version)

Standard No.

T/SDHCST 001-2023

Language

Chinese, Available in English version

Release Date

2023

Published By

Group Standards of the People's Republic of China

Latest

T/SDHCST 001-2023

Scope

This standard specifies the general principles for non-clinical research on cell therapy products and is applicable to the preclinical safety test evaluation of cell therapy products. The purpose of this standard is to elucidate the toxicological effects of a drug before human trials begin and throughout clinical development.

T/SDHCST 001-2023 history

• 2023 T/SDHCST 001-2023 General Principles on the Non-Clinical Studies of the Cell Therapy Medical Products
• 2022 T/SDHCST 001-2022 Technical Specification for Artificially Induced Pluripotent Stem Cells to Differentiate into Neural Cells
• 2021 T/SDHCST 001-2021 Specification of Intelligent Health Management Process
• 2019 T/SDHCST 001-2019 Technical Specification for Non-invasive Prenatal Gene Detection 2019
• 2018 T/SDHCST 001-2018 CTCs Technical Protocol on Immunization