SmartMedCN

Recently, the Shandong Provincial Drug Administration issued “Guiding Principles for the Construction of the Traceability System for Traditional Chinese Medicine Tablets in Manufacturing Enterprises in Shandong Province.” The Guiding Principles will be in effect by February 1, 2023 and will be valid until January 31, 2026. According to the Guiding Principles, the traceability system should adhere to the NMPA’s technical standards for data exchange and gradually achieve interconnection with provincial, extra-provincial, and national data platforms. The traceability system should establish three major traceability modules: traceability modules of the raw materials of Chinese medicine tablets, traceability modules of the production quality of Chinese medicine tablets, and traceability models of the circulation and use of Chinese medicine tablets. In addition, the Guiding Principles standardize the composition of the traceability code, which should include information such as the name of the manufacturer, the batch number, the packaging specifications, and the date of production.

《山东省中药饮片生产企业信息化追溯体系建设指导原则》发布

来源：山东省人民政府  2023.01.06

近日，山东省药监局印发《山东省中药饮片生产企业信息化追溯体系建设指导原则》。《指导原则》自2023年2月1日起施行，有效期至2026年1月31日。《指导原则》指出，追溯系统应符合国家药监局制定的数据交换技术标准，逐步实现与省内、省外和国家数据平台的对接。追溯系统应建立中药饮片原材料信息追溯、中药饮片生产质量信息追溯和中药饮片流通使用信息追溯三大信息化追溯模块。另外，《指导原则》规范了追溯码的基本构成，追溯码应包含生产企业名称、饮片批号、包装规格、生产日期等信息。