T/SHPPA 011-2021
Autologous CAR-T cell therapy medication supply chain management specifications (English Version)
- Standard No.
- T/SHPPA 011-2021
- Language
- Chinese, Available in English version
- Release Date
- 2021
- Published By
- Group Standards of the People's Republic of China
- Latest
- T/SHPPA 011-2021
- Scope
- This document stipulates the responsibilities of drug marketing authorization holders and related parties in the autologous CAR-T cell drug supply chain, and clarifies key elements such as facilities and equipment, logistics operations, and information technology in the autologous CAR-T cell drug supply chain process. , realize full-process management between patients, medical institutions, drug marketing authorization holders, drug logistics companies, and drug operating companies, and control possible risks in the supply chain through a full-process traceable quality supervision and efficient collaborative operation model , to ensure the safety and effectiveness of autologous CAR-T cell drugs.
T/SHPPA 011-2021 history
- 2021 T/SHPPA 011-2021 Autologous CAR-T cell therapy medication supply chain management specifications
