T/CAPC 011-2023 Active Group standards

T/CAPC 011-2023 The retail pharmacy shall operate the self-tissue-engineered antigen receptor T cell (CAR-T) treatment drug service in accordance with the standard

Publish Date: 2023-06-06 Implement Date: 2023-06-06 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CAPC 011-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Integrated services

Publish Date: 2023-06-06

Implement Date: 2023-06-06

Pages: 10 pages

Scope

Scope: Applicable to retail pharmacies that operate autologous chimeric antigen receptor T-cell therapy drugs, providing a series of professional pharmaceutical management services such as supply chain management, business services, and pharmaceutical services; Main technical content: 1. Retail pharmacies (hereinafter referred to as "pharmacies") that operate autologous chimeric antigen receptor T-cell therapy drugs (hereinafter referred to as "cell therapy drugs") shall strictly comply with the relevant provisions of laws and regulations such as the "Drug Administration Law", the "Quality Management Regulations for Drug Circulation", and the "Prescription Management Measures", and meet the customized and specialized service needs of cell therapy drugs in the supply chain, business operations, and pharmaceutical services in accordance with the requirements of this standard. 2. This document standardizes the supply chain guarantee and pharmaceutical services of retail pharmacies in the operation of cell therapy drugs, so that patients receiving cell therapy and their families (hereinafter referred to as "patients") can obtain quality-qualified drugs on demand while receiving standardized and uniform pharmaceutical services, and fully play the role of retail pharmacies in meeting the accessibility and safety needs of patients for special treatment products.