The necessity of standardized construction of a pharmaceutical cold chain logistics supply chain system and full process traceability
The overall scale of China's pharmaceutical logistics continues to rise. With the opening of third-party logistics, pharmaceutical logistics, especially pharmaceutical cold chain market competition is becoming increasingly fierce. At the 4th Global Pharmaceutical Supply Chain Summit held recently in 2019, a reporter from Economic Reference News learned that the pharmaceutical logistics industry as a whole is in a small and fragmented state, unable to form economies of scale, resulting in high logistics costs and many enterprises still in a state of loss. It is urgent to establish an efficient, low-cost, transparent, and safe pharmaceutical supply chain system.
The process of logistics standardization and drug traceability system construction is accelerating. Following the release of the "Guidelines for the Construction of Drug Informatization Traceability System" and the "Requirements for Drug Traceability Code Coding" two informatization standards at the end of April, on May 18th, the National Food and Drug Administration issued the basic technical requirements for the drug traceability system (draft for soliciting opinions). The industry points out that the pace of building a drug traceability system has significantly accelerated and is constantly deepening and refining. There will still be relevant standards released in the future. With the continuous improvement of the drug traceability system, the problem of low scanning rates at the logistics and user ends may be completely solved in the future, truly achieving full traceability of drugs.
The scale of medical logistics continues to rise
On May 16, 2019, the State Food and Drug Administration released the "Opinions on Three Informatization Standards, including the Basic Dataset for Vaccine Traceability (Draft for Solicitation)," which were publicly solicited by the Comprehensive Department of the State Food and Drug Administration. The documents include four documents: the Basic Dataset for Vaccine Traceability (Draft for Solicitation), the Basic Technical Requirements for Vaccine Traceability Data Exchange (Draft for Solicitation), the Basic Technical Requirements for Drug Traceability System (Draft for Solicitation), and the Feedback Form for Standard Solicitation, Conduct a one month consultation process.
The report shows that the total cost of pharmaceutical logistics in China in 2018 was 61.392 billion yuan, a year-on-year increase of 12.90%, and an increase of 0.13 percentage points compared to the previous year. In 2018, the main business revenue of China's pharmaceutical industry enterprises increased by 12.7%, with a growth rate of over 10% for two consecutive years. In the first 11 months of 2018, the total number of medical and health institutions in China reached 7.54 billion, an increase of 3.2% year-on-year.
The China Union of Things Pharmaceutical Logistics Branch pointed out that the growth of supply and demand directly drives the rapid growth of pharmaceutical logistics. In addition, the increase in human resource costs and the increased difficulty in management after the two ticket system are also important reasons for the increase in pharmaceutical logistics costs.
Vaccine Traceability Basic Dataset: Used to guide the construction of vaccine traceability systems, it specifies the classification, data provider relationships, and content of vaccine traceability basic datasets related to the construction of vaccine traceability systems.
Divided into two categories:
The basic information data subset includes the basic data and supplementary content distributed by the vaccine traceability collaborative service platform;
The subset of application information data includes traceability information throughout the entire process of vaccine production, circulation, and use. Please refer to Table 1 for specific information.
Table 1 List of Basic Data Subsets for Vaccine Traceability
The document indicates that vaccine traceability data providers include: vaccine marketing license holders and production enterprises, disease prevention and control institutions, and vaccination units. The subset of data that each data provider should provide to the vaccine traceability system is shown in Table 2.
Table 2: Subsets of data that each data provider should provide to the vaccine traceability system
2、 Basic Technical Requirements for Drug Traceability System (Draft for Soliciting Opinions)
This standard specifies the general requirements, functional requirements, storage requirements, safety requirements, and operation and maintenance requirements for drug traceability systems (hereinafter referred to as traceability systems).
Applicable to guiding the construction and use traceability system of drug traceability system participants such as drug marketing license holders, production enterprises, operating enterprises, user units, and third-party technical institutions.
The document specifies the drug traceability collaborative service platform, drug traceability system, drug traceability code, and drug identification code.
3、 Basic technical requirements for vaccine traceability data exchange (draft for soliciting opinions)
It specifies the requirements for the exchange of vaccine traceability data, data format, data content, performance, and safety in the vaccine traceability system. Applicable to guiding all parties involved in vaccine traceability to exchange vaccine traceability data.
Vaccine traceability data exchange refers to the information exchange related to traceability between the vaccine traceability regulatory system (hereinafter referred to as the regulatory system), the vaccine traceability collaborative service platform (hereinafter referred to as the collaborative platform), and the vaccine traceability system (hereinafter referred to as the traceability system), as shown in Figure 1.
Figure 1 Schematic diagram of data exchange relationship in vaccine traceability system
The benefits of establishing a vaccine traceability system?
1. Transparency of vaccine production records.
If the enterprise establishes a vaccine traceability system, the traceability system can clearly record the production process of the vaccine, and the traceability system can clearly record every thing done by each person in each batch of vaccine production, truly achieving "responsibility to batch, responsibility to person".
2. Protect people's lives and health.
We all need to be vaccinated from childhood to adulthood, so the issue of vaccines is related to everyone's life and health. It is necessary to ensure vaccine safety. Only by establishing a vaccine traceability system can we ensure the safety of vaccines from the source and protect people's lives.
As early as July 12, 2018, Shanghai had established a comprehensive management information system for vaccines and vaccination, which was the first in the country to achieve comprehensive management based on information systems covering the entire process, including procurement, supply, warehousing, logistics, and vaccination of Class 1 and Class 2 vaccines.
3. Establish brand image.
By establishing a vaccine traceability system, the vaccine production process can be transparent and open, providing consumers with favorable product quality certificates. Before using the product, detailed information about the product can be obtained, ensuring that the source can be traced and the destination can be traced, preventing the occurrence of counterfeit and inferior products that affect people's health, and establishing a brand image.
Branch viewpoint:
On April 28, 2019, the National Food and Drug Administration issued two informatization standards: "Guidelines for the Construction of Drug Informatization Traceability System" and "Requirements for Drug Traceability Code Coding". Following yesterday's release of the "Basic Technical Requirements for Drug Traceability System (Draft for Soliciting Opinions)", it can be seen that the preparation of a series of standards for drug traceability informatization is constantly improving, and there will still be relevant standards to be released in the future. At the same time, it indicates that the pace of building a drug traceability system has significantly accelerated and is constantly deepening and refining.
Establishing a separate traceability system for vaccines fully demonstrates that the country attaches great importance to vaccine safety. Strictly implement requirements to ensure the quality and safety of vaccine products.
From the table of "subsets of data that each data provider should provide to the vaccine traceability system", it can be seen that vaccine marketing licensors and production enterprises bear the main responsibility in the vaccine traceability system;
The provider of vaccine traceability data does not include the distribution enterprise. The traceability data of the distribution enterprise is attributed to the production enterprise, and the production enterprise conducts quality and safety checks on the distribution enterprise, which is conducive to clarifying the main responsibility position of the production enterprise and strengthening its quality and safety management.
With the continuous improvement of the drug traceability system, the problem of low scanning rates at the logistics and user ends may be completely solved in the future, truly achieving full traceability of drugs.
Among them, the basic technical requirements for drug traceability systems (draft for soliciting opinions) stipulate the general requirements, functional requirements, storage requirements, safety requirements, and operation and maintenance requirements of drug traceability systems. Applicable to guiding the construction and use traceability system of drug traceability system participants such as drug marketing license holders, production enterprises, operating enterprises, user units, and third-party technical institutions. The document specifies the drug traceability collaborative service platform, drug traceability system, drug traceability code, and drug identification code.
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