Simplified Chinese
The National Medical Products Administration has released three standards, including the “Basic Data Set for Vaccine Traceability.”
Release date:
2019-09-11
Author:
Article/Excerpted from the National Medical Products Administration
Source:
Abstract
On August 26, the National Medical Products Administration issued three information‑technology standards: the “Basic Dataset for Vaccine Traceability,” the “Basic Technical Requirements for Vaccine Traceability Data Exchange,” and the “Basic Technical Requirements for Pharmaceutical Traceability Systems.” Together with the two standards previously released in April 2019—the “Guidelines for Building a Pharmaceutical Information‑Based Traceability System” and the “Coding Requirements for Pharmaceutical Traceability Codes”—all five standards required for establishing an information‑based vaccine traceability system have now been promulgated and put into effect.
Unified standards and specifications constitute a critical foundation for building an information‑based pharmaceutical traceability system and serve as an essential prerequisite for the aggregation and analysis of traceability data. To implement relevant regulations on pharmaceutical traceability and advance the development of such a system, the National Medical Products Administration launched, in May 2018, the formulation of pharmaceutical traceability standards and specifications. These documents define the overarching requirements for establishing an information‑based pharmaceutical traceability system, standardize the coding rules for pharmaceutical traceability codes, specify the content and formats that enterprises must record throughout the traceability process, and set forth data‑exchange requirements, thereby guiding all stakeholders to collaboratively build a unified, information‑driven pharmaceutical traceability framework.
To implement the Vaccine Administration Law of the People’s Republic of China, and in view of the special nature and urgency of building an information-based vaccine traceability system, the National Medical Products Administration has accelerated the development of data and exchange standards for vaccine traceability. The five standards already issued are both mutually coordinated and each emphasizes distinct aspects, effectively addressing the challenge of data sharing across different stages and systems in the vaccine traceability process, thereby laying the groundwork for promptly achieving the requirement set forth in the Vaccine Administration Law—that vaccines be traceable and verifiable at the level of the smallest packaging unit throughout the entire process.
The “Guidelines for the Construction of a Pharmaceutical Information Traceability System” sets forth the basic components and functional requirements of such a system, as well as the specific responsibilities of its various stakeholders, including marketing authorization holders/manufacturers, distributors, users, and regulatory authorities.
The “Requirements for Pharmaceutical Traceability Code Coding” specifies the detailed requirements for pharmaceutical traceability codes, including coding principles, coding objects, and structural requirements. Marketing Authorization Holders and manufacturers shall, based on the coding object, select specific coding rules that comply with the provisions of this standard to carry out coding, thereby achieving item‑level serialization of pharmaceutical products.
The “Basic Technical Requirements for Pharmaceutical Traceability Systems” sets forth specific requirements—covering system functionality, data storage, and security‑related operations and maintenance—for pharmaceutical traceability systems developed either in-house by enterprises or by third parties. It provides guidance to marketing authorization holders and manufacturers on establishing their own systems in accordance with these standards or on selecting third-party traceability systems that meet the specified criteria.
The “Basic Dataset for Vaccine Traceability” sets forth specific requirements for vaccine marketing authorization holders/manufacturers, distribution entities, disease prevention and control institutions, and vaccination sites regarding the collection and storage of traceability information, and clarifies the types of data that these traceability stakeholders are required to collect and retain throughout the traceability process.
The “Basic Technical Requirements for Vaccine Traceability Data Exchange” sets forth specific requirements for vaccine marketing authorization holders/manufacturers, distribution entities, disease prevention and control institutions, and vaccination sites regarding traceability data exchange. It clarifies the exchange technologies, content, and formats, and establishes security requirements for such exchanges.
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