On October 10, 2020, NMPA made an announcement in relation for Drug Information Traceability System for key drug products (Circular No. 2020/111)
Marketing authorization holders (MAHs) take the main responsibility for establishing the system and collection of drug traceability information over the whole process, to be able to ensure that national centralized procurement winning bids, narcotic drugs, psychotropic drugs and blood products are traceable before December 31, 2020.
At time of issue of the announcement, all 8 standards for the construction of drug information traceability system have been issued and implemented by NMPA, including “Guidelines for the Construction of Drug Information Traceability System”, “Encoding requirements for drug traceability code”, “Basic Technical Requirements for Drug Traceability System”, and “Basic dataset of drug traceability for marketing authorization holders and manufacturers”, “Basic dataset of drug traceability for distributors”, “Basic dataset of drug traceability for medical organizations”, “Basic dataset of drug traceability for consumer inquiry”, and “Basic Technical Requirements for drug traceability data exchange”.
MAHs and drug distributors shall establish and implement drug traceability systems in accordance with the “Guidelines for the Construction of Drug Information Traceability” and other standards and regulations, provide traceability information, and ensure that drugs are traceable. MAH shall bear the main responsibility for the construction of the traceability system. MAH can build the traceability system on their own or entrust the construction to a third-party technical organization in accordance with the unified drug traceability coding requirements in which the each level of packaging units are assigned a unique traceability identification. Traceability code for the same drug can only be traced in the same traceability system. If the company wants to change the traceability code or the traceability system, it can make changes on the collaborative platform as required. When storing after manufacturing, the information should be stored in the traceability system. During the sale of the drugs, the traceability system should be used to provide relevant traceability information to downstream enterprises or medical institutions so that downstream enterprises or medical institutions can verify. MAH ensure timely and accurate information about the entire lifecycle of the drug can be obtained.
MAHs may entrust their importing drug agency to perform the responsibility for the construction of the traceability system.
When purchasing drugs, drug distributors should obtain relevant traceability information from upstream companies through the traceability system, check the information at the time of acceptance, and transmit the verification information back to the upstream companies through the traceability system; when selling drugs, they should use the traceability system to provide traceability information the downstream companies or relevant agencies
An explanatory note published on the 13 October 2020 for the NMPA adopted a Q&A format to provide further interpretation of the Circular No. 2020/111, covering:
1.What is the time limit for the construction of the drug information traceability system?
2. How does the holder of the drug marketing authorization record basic information and traceability code encoding rules? How to implement the encoding of the product?
3. How does MAH obtain and upload drug traceability information for drug distributors and users?
4. What are the main responsibilities of the provincial drug regulatory authorities?
For more information, please refer to the NMPA website:
- 国家药监局关于做好重点品种信息化追溯体系建设工作的公告（2020年第111号）
https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20201013155906186.html - 关于做好重点品种信息化追溯体系建设工作的公告解读
https://www.nmpa.gov.cn/xxgk/zhcjd/zhcjdyp/20201013170457140.html
Related documents:
- Guiding Opinions of the China National Drug Administration on the Construction of Drug Information Traceability System (CNDA Department of Drug Supervision [2018] No. 35)
国家药监局关于药品信息化追溯体系建设的指导意见https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20181101100801272.html - Guidelines for drug traceability information system construction:
药品信息化追溯体系建设导则 - Encoding requirements for drug traceability code:
药品追溯码编码要求 - Basic technical requirements for drug traceability system:
药品追溯系统基本技术要求 - Basic dataset of drug traceability for marketing authorization holders and manufacturers:
药品上市许可持有人和生产企业追溯 基本数据集 - Basic dataset of drug traceability for distributors:
药品经营企业追溯基本数据集 - Basic dataset of drug traceability for medical organisations:
药品使用单位追溯基本数据集 - Basic dataset of drug traceability for consumer inquiry:
药品追溯消费者查询基本数据集 - Basic Technical Requirements for drug traceability data exchange:
药品追溯数据交换基本技术要求f - Basic dataset for vaccine traceability:
疫苗追溯基本数据集 - Basic technical requirements for vaccine traceability data exchange:
疫苗追溯数据交换基本技术要求