Standard No.:	T/SHSPTA 001-2023
English Name:	Specification of supply chain management for investigational medicinal products
Chinese Name:	临床试验用药品供应链管理规范
Chinese Classification:	C00    Standardization and quality management
Professional Classification:	T/    Social Organization Standard
ICS Classification:	03.120.10 03.120.10    Quality management and quality assurance 03.120.10
Source Content Issued by:	Shanghai Pharmaceutical Trade Association‌
Issued on:	2023-01-10
Implemented on:	2023-3-1
Status:	valid
Target Language:	English
File Format:	PDF

本文件规定了临床试验用药品供应链环节中各相关方、人员、设施设备、数字化信息平台、质量管理、过程管理、档案管理等方面的要求。
本文件适用于为申请药品注册而进行的临床试验用药品供应链管理，其他临床研究用药品供应链管理亦可参考执行。