On August 26, the State Food and Drug Administration issued three informatization standards: Basic Vaccine Traceability Data Set, Basic Technical Requirements for Vaccine Traceability Data Exchange, and Basic Technical Requirements for Drug Traceability System. In addition to the two standards of "Guidelines for the Construction of Drug Information Traceability System" and "Code Requirements for Drug Traceability Code", which have been released in April 2019, all five standards required for the construction of the vaccine information traceability system have been released and implemented.
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The Food and Drug Administration released three standards including "Basic Data Set for Vaccine Traceability"
Uniform standards and specifications are an important foundation for the construction of drug information traceability system and an important prerequisite for the aggregation and analysis of drug traceability data. In order to implement the relevant laws and regulations on drug traceability and promote the construction of the drug information traceability system, the State Drug Administration initiated the preparation of drug traceability standards in May 2018, clarified the overall requirements for the drug information traceability system, and unified the drug traceability code The rule proposes that the content and format of the information required by the company to record information during the drug tracing process, as well as data exchange requirements, etc., and guides relevant parties to jointly build a drug information tracing system under a unified standard.
In order to implement the "Vaccine Management Law of the People's Republic of China", taking into account the particularity and urgency of the construction of the vaccine information traceability system, the State Food and Drug Administration accelerated the preparation of vaccine traceability data and exchange standards. The five standards that have been published are coordinated with each other and each has its own focus, effectively solving the problem of data sharing in different links and different systems in the vaccine tracing process. The unit vaccine can be traced and verified "laying the foundation.
The "Guidelines for the Construction of the Drug Information Traceability System" stipulates the basic composition and functional requirements of the drug information traceability system, as well as the participation of drug information traceability systems such as drug marketing license holders / manufacturing companies, operating companies, users, and regulatory authorities. Specific tasks.
"Code Requirements for Drug Traceability Codes" specifies the specific requirements for drug traceability codes, including coding principles, coding objects and composition requirements. Drug marketing license holders / manufacturing enterprises should select specific coding rules that meet the requirements of this standard for coding according to the coding objects , Complete the "one thing, one code" drug serialization work.
The "Basic Technical Requirements for Drug Traceability System" sets out specific requirements for system functions, data storage, and safe operation and maintenance of drug traceability systems built by enterprises or third parties, and guides drug market holders / manufacturing companies to build or choose according to standards. A third-party drug traceability system that meets the requirements.
The “Basic Data Set for Vaccine Traceability” sets specific requirements for the collection and storage of traceability information for vaccine marketing license holders / manufacturing companies, distribution units, disease prevention and control institutions, and vaccination units. Data content that should be collected and stored.
"Basic technical requirements for vaccine retrospective data exchange" puts forward specific requirements for retrospective data exchange for vaccine marketing license holders / manufacturing enterprises, distribution units, disease prevention and control institutions and vaccination units, clarifying the exchange technology, exchange content and exchange format, Exchange security requirements were put forward.