Industry News
Introduction to Guiding Opinions on the Construction of Traceability System of Pharmaceutical Informatization
2019-09-07 15:58:23 Source:

The Guidelines on the Construction of Drug Information Traceability System issued by the State Drug Administration in November 2018 triggered a heated discussion between pharmaceutical enterprises and third-party enterprises. The Guidelines on the Construction of Pharmaceutical Information Traceability System put forward that "drug licensing holders and manufacturers can build their own drug information traceability system, or use the services of third-party technical institutions." "Information technology enterprises are encouraged to act as third-party technical institutions to provide information technology services for drug traceability for drug licensing holders, manufacturing enterprises, business enterprises and users." With the advancement of drug traceability system, many third-party enterprises began to make efforts in the construction of drug traceability system, trying to take the lead.

Demand for Digital Asset Derivative Services

"Guidelines on the construction of drug information traceability system" pointed out that "relevant parties are encouraged to use drug traceability data to serve the society in accordance with legal and compliance methods." This means that expanding the value of drug traceability data has been recognized and supported by the national drug regulatory authorities. Relevant people pointed out that services generated around retrospective data will usher in explosive growth.


"In the past, pharmaceutical production and marketing enterprises were passive in fulfilling traceability requirements, so most enterprises made the choice of minimum investment, and traceability information system was simple because of its poor quality. Even if there are enterprises around the previous electronic regulatory code to establish production control, circulation traceability and other applications, but because of the lack of access to upstream and downstream data or data chains are too short, can not produce a good system effect. The Guidelines on the Construction of Traceability System for Pharmaceutical Informatization fully considers the needs of drug supervision and informatization construction of pharmaceutical enterprises, and adopts an open regulatory strategy, which fully releases the application value of traceability codes. Huang Futuo, deputy general manager of Beijing Jiahua Huicheng Science and Technology Co., Ltd., believes that under the framework of national coordinated supervision, the production, storage and consumption of traceable data in pharmaceutical enterprises can be divided into market-oriented ways, which can improve the value of data composite and make data truly become the digital assets of enterprises. In this process, there will be a large number of demand for technical services, which is a huge incremental market, third-party information service enterprises will usher in the performance explosion growth.

The construction of drug traceability system also promotes the improvement of drug liability insurance system. "The construction of drug traceability system and drug liability insurance mechanism are complementary and mutually reinforcing." Zhang Peng, Director of the Political Insurance Department of China Life and Property Insurance Co., Ltd., believes that the construction of drug traceability system can provide precise positioning and traceability data support for drug liability insurance in terms of drug insurance pricing, risk control and claim management, while drug liability insurance can provide more dimensions for drug traceability system. Degree of risk management methodology, insurance data information, to help promote the improvement of the information system.

Market expansion enterprises rush to land on the beach

In recent years, when the national drug regulatory authorities and pharmaceutical production and marketing enterprises accelerate the construction of drug traceability system, the third-party enterprises with "sensitive smell" have been "waiting for opportunities" to strive for market share. After the introduction of "Guidelines on the Construction of Drug Information Traceability System", a new market space for data services will be opened. In order to seize the commanding heights of this stage of market competition, Jiahua Huicheng has put forward the goal of service and internationalization of its products.


"We have participated in the construction of drug traceability system from the aspects of traceability standards, key technologies, product applications and so on." Ma Zhenzhou, deputy general manager of Aerospace Information Co., Ltd., introduced that Aerospace Information participated in the subject of drug traceability standards of the Information Center of the National Drug Administration. It also jointly carried out related research work on traceability code identification and analysis with the China Institute of Information and Communication, focusing on promoting the development of key traceability technologies. In terms of product applications, aerospace information is establishing a vaccine traceability platform. At the same time, we are planning and gradually building a provincial drug traceability management platform for some provincial drug regulatory authorities.

According to Zhang Peng, China Life and Property Insurance Co-operates with the third party in the construction of information traceability system to provide a package of risk management services for customers from the perspective of information technology, including drug traceability risk early warning, safety risk prevention, information-based credit traceability management of partners, etc.

Safety is the first guarantee of compliance and reliability

The key problems in the construction of drug traceability system are "safety" and "connectivity". How should third-party enterprises solve this problem?

Ma Zhenzhou introduced that in the future, aerospace information will comprehensively promote the development of drug traceability business from the perspective of innovative technology application and expanding the scope of traceability. The Space Information Program (SIP) fully combines with the drug traceability system by utilizing the mature block chain technology. On the one hand, data reliability, safety and compliance can be effectively guaranteed; on the other hand, in the form of alliance chain in block chain, drug traceability social co-governance system with government supervision, enterprise-led and consumer participation can be effectively constructed. In terms of traceability scope, aerospace information will be based on the previous multi-provincial drug traceability and gradually build a unified regional and even national drug traceability system.

"With the enhancement of third-party service capability, enterprises will gradually move from self-modeling mode to service purchase mode. Pharmaceutical enterprises will soon enjoy the great value of retrospective data, but how to ensure the rational use of data is a major challenge. Perfect information service laws and regulations are the important guarantee to prevent third-party enterprises from "doing evil", while technological innovation is also an effective means to combat security fears. Huang Fu's introduction.

Zhang Peng introduced that China Life and Property Insurance is committed to promoting the connection and communication of the "last kilometer" of the drug traceability system, as well as improving the drug traceability system, and comprehensively guaranteeing the security of the information traceability system through the insurance + network security service model.