The Drug Administration issued three standards, such as the Basic Data Set for Vaccine Traces

August 26, the State Drug Administration issued three information standards: "Basic Data Set for Vaccine Traceability", "Basic Technical Requirements for Vaccine TraceAbility Data Exchange" and "Basic Technical Requirements for Drug Trace Systems". In addition to the previous release in April 2019, "Drug information traceability system construction guidance" "drug traceability code coding requirements" 2 standards, vaccine information tracing system construction required 5 standards have all been issued and implemented.
Uniform standard standard is an important foundation for the construction of drug information traceability system and an important prerequisite for drug traceability data aggregation and analysis. In order to implement the relevant laws and regulations on drug traceability and promote the construction of drug information traceability system, the State Drug Administration started the preparation of drug traceability standards in May 2018, to clarify the overall requirements for the construction of drug traceability system, to unify drug traceability code coding rules, to propose the content and format of information required for enterprise records in the process of drug traceability, and data exchange requirements, to guide relevant parties to jointly build a drug traceability system under unified standards.
In order to implement the Vaccine Management Law of the People's Republic of China, the State Drug Administration has accelerated the compilation of vaccine traceability data and exchange standards, taking into account the particularity and urgency of the construction of the vaccine information traceability system. The five standards that have been issued are not only coordinated with each other, but also have their own focus, effectively solve the problem of data sharing of different systems in different links in the vaccine traceability process, and lay the foundation for the early realization of the "full process minimum packaging unit vaccine traceability and verifiability" required by the Vaccine Management Law of the People's Republic of China.
The Guidelines for the Construction of the Drug Information Trace System stipulate the basic composition and functional requirements of the Drug Information Trace system, as well as the specific tasks of the drug information traceability system participants such as drug listing license holders/production enterprises, operating enterprises, user units, regulatory authorities, etc.
The Drug Trace Code Code Requirements specify the specific requirements of drug traceability code, including coding principles, coding objects and composition requirements, and drug market license holders/production enterprises shall, in accordance with the coding objects, select specific coding rules that meet the requirements of this standard, and complete the serialization of drugs "one thing, one yard".
The Basic Technical Requirements of the Drug Trace System put forward specific requirements for the drug traceability system built by the enterprise itself or built by a third party, and instructed the drug listing holders/production enterprises to build themselves according to the standards or to select a third-party drug traceability system that meets the requirements.
The Basic Data Set of Vaccine Traces puts forward specific requirements for the collection and storage of retrospective information by vaccine listing licensees/manufacturers, distribution units, disease prevention and control agencies and vaccination units, and clarifies the contents of the data that should be collected and stored by the above-mentioned traceability participants in the traceability process.
The Basic Technical Requirements for Vaccine Retrospective Data Exchange put forward specific requirements for retrospective data exchange for vaccine-listed licensees/manufacturers, distribution units, disease prevention and control agencies and vaccination units, clarified the exchange technology, exchange content and exchange format, and put forward exchange safety requirements. (National Drug Administration) Annex:the
of vaccine traceability standards is