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NMPA: establishing a traceabiliy system of specially regulated drugs

January 18th, 2021 | by

On August 28th, the NMPA issued the “Notice of establishing the traceability system of special drugs.” The Notice indicates that the Marketing Authorization Holders should establish traceability systems and collect the information from the traceability process to realise the traceability of special regulated drugs, such as selected drugs, before December 31st. At the meantime, the NMPA should establish a Coordination Platform of traceability systems, which provides coding rules of drug traceability codes and services that encode the IP-Adresse of traceability systems that are established by Marketing Authorization Holders to help to realise the information sharing between the different traceability systems.

国家药监局:做好重点品种信息化追溯体系建设工作

来源医药网  2020.10.14

8月28日国家药监局发布《关于做好重点品种信息化追溯体系建设工作的公告》。《公告》指出,药品上市许可持有人应建立信息化追溯系统并收集全过程追溯信息,于2020年12月31日之前,基本实现国家药品集中采购中选品种等重点品种可追溯。同时,国家药监局应建设药品追溯协同服务平台,协同平台提供药品追溯码编码规则备案和药品上市许可持有人药品信息化追溯系统地址解析服务,辅助实现不同追溯系统互通互享。

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