Breaking news: The National Medical Products Administration has released guiding opinions on the establishment of an information-based traceability system for pharmaceuticals.
Release time:2025-09-29
To implement the “Opinions of the General Administration of Food and Drug Administration on Promoting Food and Drug Producers and Operators to Improve Their Traceability Systems” (SFDA Science and Technology [2016] No. 122) and the “Guiding Opinions of the Ministry of Commerce and Other Departments on Promoting the Construction of an Information-Based Traceability System for Key Products,”
In accordance with regulations such as “Shangzhi Fa [2017] No. 53,” the National Medical Products Administration has now officially issued the “Guiding Opinions on the Construction of a Pharmaceutical Information Traceability System.”
National Medical Products Administration
I. Important Guiding Principles
In accordance with the strategic plans and deployments, and with the goal of ensuring public drug safety as our primary objective, grounded in the implementation of enterprises’ principal responsibilities, and guided by the vision of achieving “one product, one code; traceability of both product and code,” we will accelerate the development of an information-based drug traceability system. We will strengthen the interoperability and sharing of traceability information to enable full-product, end-to-end traceability, promote comprehensive governance of drug quality and safety, and enhance the overall level of drug quality and safety assurance.
The marketing authorization holder, manufacturer, distributor, and user entity each bear their own responsibilities. As the primary entities responsible for drug quality and safety, the marketing authorization holder, manufacturer, distributor, and user entity are obligated to ensure traceability. A drug traceability system should be established through information technology, enabling timely and accurate recording and storage of drug traceability data, thereby creating an interconnected chain of drug traceability data. This will make it possible to trace the origin and track the destination of drugs throughout the entire process—from production and distribution to use—effectively preventing illegal drugs from entering legitimate channels. It will also ensure that drugs posing quality and safety risks can be recalled and that accountability can be assigned. Furthermore, information technology enterprises are encouraged to serve as third-party technical institutions, providing drug traceability information technology services to marketing authorization holders, manufacturers, distributors, and user entities. Together, the stages of drug production, distribution, and use will jointly build a comprehensive drug traceability system covering the entire process, thereby enhancing society’s awareness and understanding of drug traceability through information technology.
II. Clearly state the requirements.
Key products such as vaccine pharmaceuticals, easily controlled chemical substances, and blood products should be the first to establish an information-based drug traceability system. Information-based drug traceability systems for commonly-concerned products—such as essential medicines and drugs covered by medical insurance—should be established as soon as possible. Other pharmaceutical products will be gradually incorporated into the information-based drug traceability system.
Guangzhou Huiyi Intelligent Technology
III. Huiyi Intelligent Technology
Guangzhou Huiyi Intelligent Technology was established in 2011 in the Guangzhou Economic Development Zone. It is a specialized company integrating R&D, manufacturing, sales, and service in areas such as QR code tracking systems, automatic labeling machines, vision-based quality inspection equipment, and automated labeling and data collection systems.
Manufacturing enterprises can leverage a QR code traceability system to provide customers with end-to-end traceability, anti-counterfeiting and anti-diversion features, and a one-item-one-code integrated solution. This system is applied throughout the entire process—from production and packaging to distribution channels, logistics, and retail.
Building a traceability system gives consumers peace of mind by enabling them to know exactly where products come from. For businesses, it strengthens control over the entire upstream and downstream supply chain and establishes a direct connection with consumers, thereby boosting marketing efforts. From the perspective of regulatory authorities, the entire process is transparent and trustworthy.
Transparent and intelligent supervision, coupled with an improved risk-warning mechanism—traceability systems are beneficial to the country and its people, whether for you, for me, or for him.
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