According to the information released by the State Pharmaceutical Administration, on August 26, the State Pharmaceutical Administration issued three standards: Basic Data Set for Vaccine Traceability, Basic Technical Requirements for Vaccine Traceability Data Exchange and Basic Technical Requirements for Drug Traceability System, together with Guidelines for the Construction of Drug Information Traceability System and Drug Traceability Code issued in April this year. The two standards of Coding Requirements and the five standards required for the construction of vaccine information traceability system have been released and implemented.

The State Administration of Pharmaceutical Supervision said that unified standards and norms are an important basis for the construction of drug information traceability system and an important prerequisite for the collection and analysis of drug traceability data.

In order to solve the problems of co-existence of multi-traceability systems, difficulty in data sharing and collaboration, and difficulty in cross-regional traceability in China, in May 2018, the State Pharmaceutical Regulatory Bureau launched the formulation of standards and standards for drug traceability, clarified the overall requirements for the construction of drug informationization traceability system, unified coding rules for drug traceability codes, and put forward some suggestions. In the process of drug traceability, the content and format of enterprise record information and the requirement of data exchange are needed to guide the relevant parties to build a drug information traceability system under a unified standard.

The five standards released this year are helpful to solve the data sharing problem of different systems in different links in the process of vaccine traceability, and provide direction for all parties to carry out the construction of vaccine traceability system.

According to the interpretation of the standards and norms of vaccine traceability by the State Pharmaceutical Administration, the information traceability system of vaccines is an important part of the information traceability system of drugs. It refers to the participants in vaccine traceability, such as the holder/manufacturer, distribution unit, disease prevention and control agency, vaccination unit, supervision department, etc., through information. It is an organic whole that traces and traces the information of vaccine production, circulation and use.

From the scope of application of these five standards, the Guidelines for the Construction of Drug Information Traceability System, Coding Requirements for Drug Traceability Code and Basic Technical Requirements for Drug Traceability System are the basic general standards, while the Basic Data Set for Vaccine Traceability and Basic Technical Requirements for Vaccine Traceability Data Exchange are based on the special requirements of vaccine management. Sex, a standard tailored for vaccine traceability.

These five standards stipulate the specific tasks of each participant and the specific requirements of drug traceability codes. The drug traceability system built by enterprises or by third parties needs to meet the specific requirements of system functions, data storage and safe operation and maintenance. Participants in the vaccine informatization traceability system need to meet the specific requirements of retrospective information collection and storage. Requirements, as well as specific technical requirements for retrospective data transmission and exchange.

According to the industry, vaccines belong to special drugs, and their supervision needs to pay attention to every link. Any loophole in any link will cause serious consequences. Among them, Jerry work in production links, irregular operation process and other situations will cause major security risks. In the process of circulation, there may also be some problems, such as sub-optimal vaccines after they leave the factory, transportation not in accordance with the requirements of cold chain, and so on. "Even if all vaccines are qualified when they are delivered to the vaccination unit, the vaccines may expire or be dispatched during the vaccination phase. So vaccine traceability needs to cover the whole process.

It can be seen that, with the landing of these five standards, there are strict requirements for all participants in traceability of drugs (including vaccines). Vaccines can be traceable from production to circulation and even the use of vaccines, which can effectively guarantee the safety of vaccines and enhance the safety of vaccinators.