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The State issued two construction standards of the information-based traceability system of drugs

October 8th, 2019 | by

Recently, the National Medical Products Administration issued the “Guideline on the construction of an information-based traceability system of drugs” and the „Requests for the coding of the drug traceability code,” which will be implemented since the release date. The “Guideline” indicates that the information-based traceability system should contain a drug traceability system, a collaborative service platform, and a regulatory system. Besides, it should also include the traceability information in the whole process of drug production, circulation, and use, and it fulfils the function of collecting, storing, and sharing the traceability information. The system can be divided into two categories: self-built traceability system of enterprises and traceability system provided by third-party institutions.

两项药品信息化追溯体系建设标准出炉,保证药品信息安全

来源:制药网 2019.05.06

核心提示:日前,国家药监局发布了《药品信息化追溯体系建设导则》(以下简称《导则》)和《药品追溯码编码要求》两项信息化标准,并于发布日起实施。《导则》指出,药品信息化追溯体系应包含药品追溯系统、药品追溯协同服务平台和药品追溯监管系统。同时,还应包含药品在生产、流通及使用等全过程追溯信息,并具有对追溯信息的采集、存储和共享功能,可分为企业自建追溯系统和第三方机构提供的追溯系统两大类。

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