The “Seminar on Drug Safety Traceability System Construction Theory and Practice” initiated by China Pharmaceutical Industry Association, China Association of Pharmaceutical Commerce, PSM FOUNDATION and RDPAC and co-sponsored by Beijing Acctrue Technology Co., Ltd. was successfully held in Beijing on November 28. The seminar aims to learn the experience of international drug safety traceability, discuss the true path for constructing the drug safety traceability system in China and how to promote the “global unified identification system” (GS1 system) in pharmaceutical industry, so that the pharmaceutical traceability standard in China can be docked with the world. Xie Zhaohui, the President of Acctrue Technology, was invited to make the keynote speech Service Guidelines for Production Line Upgrading and Third-Party Traceability Platform Based on GS1 International Code Standard at the conference.

Common science knowledge about GS1 

GS1 system is the “global unified identification system” and the open standard system that takes the encoding of trade projects, logistics unit, positions, assets and service relation as the core, integrates automatic data acquisition such as barcode and radio frequency, electronic data exchange, global product classification, global data synchronization and product electronic code (EPC) into a whole and serves for the global logistics supply chain.

Based on the commodity barcode, GS1 system has been widely applied in many industries such as business, logistics, food safety, medical and health care, publishing, finance and insurance and services, and become the world universal business language. So far, more than 150 countries and regions and over 2,500,000 enterprises have adopted the national standard of GS1 system. The scanning times of commodity barcode can be up to 5 billion in the world every day.

It is imperative to trace drug based on GS1 standard 

With the globalization of drug supply chain, all pharmaceutical companies are confronted with the problems brought by drug safety. Therefore, traceability system law gradually becomes a mandatory law/industrial standard of all pharmaceutical supply chains in the world. Both Prescription Drug Marketing Act (PDMA) of the United States and Falsified Medicines Directive (FMD) of EU have clear requirements for establishing data information for drug.

So far, more than 40 countries have promulgated drug traceability laws based on GS1 system. It is estimated that 80% of drug in the world will be serialized by 2022, and GS1 system will become the world trend.

On October 31, the Guidelines of National Medical Products Administration on Drug Information Traceability System Construction of National Medical Products Administration was formally issued. As a large pharmaceutical country, China is undergoing the globalization. If we only establish our own traceability coding system, how could we integrate into the international environment in the future? Therefore, it is necessary to establish a global traceability coding system.

Acctrue + GS1 digitalization supply chain 

Acctrue Technology initiates that all pharmaceutical enterprises should follow the GS1 coding system based on its deep understanding in pharmaceutical traceability policies and rich project experiences. Unify the drug traceability codes based on the principle of “unique code for product” and the GS1 coding system, realize full coverage of all drug, whole-process association and whole network sharing, break through all industry links to trace data, implement unified management, ensure all drug can be traced and checked, define the entity responsibility of all links and guarantee the medication safety of the public.

Acctrue takes “cloud + management + terminal” as the overall structure and provide three digital service modes according to the demand of pharmaceutical enterprises, that is,

      1.“Cloud + terminal”: suitable for small pharmaceutical enterprises, establishing the tagging system and realizing drug traceability through third-party traceability platform.

      2.“Management + terminal”: suitable for medium-sized pharmaceutical enterprises, the enterprise data is “privatized, not only meeting the supervision requirements, but also sharing data and information with the enterprise’s information system and breaking through information islet.

      3.“Cloud + management + terminal”: suitable for large-scale pharmaceutical enterprises, realizing integration of traceability system and ERP, warehousing and logistics, exchanging data with the industrial or government institutions through the third-party traceability platform, forming the enterprise’s big data, optimizing enterprise management and meeting the development need.

Value of Acctrue digital supply chain 

Packing material enterprises:

Provide code application entry management for packing material enterprises based on the GS1 coding rules and effectively control code outflow and reuse;

Pharmaceutical enterprises:

Establish “additional information codes such as GTIN + batch number and validity” for products, associate the batch number with finished product packages and realize product tracking and information tracing;

Circulation enterprises:

Manage the in-stock, sorting, checking, out-stock and recheck of products by means of barcodes;

Retail enterprises:

Stock, sell, store, deploy, change/refund, check and manage the validity period of drug; as well as personnel encouragement and event promotion scheme implementation;

Medical institutions:

Deliver, receive, distribute, use and track the products through GTIN and SSCC. Identify the internal departments and equipment of patients and medical institutions with other GS1 ID codes and barcodes;

In the era of globalization of drug production and sales, it is very necessary to adopt a unified traceability standard to ensure the global traceability of drug. As the international business language, GS1 standard has been recognized by more and more government and international organizations and enterprises, it plays increasing important role in promoting the global traceability of products.

Acctrue Technology is committed to promoting the deep application of GS1 unified code in pharmaceutical enterprises and identifying the GS1 code for each drug. The industry chain digitalization is started from a certain node and extends toward the upstream and downstream value chains. Digital information runs through the whole industry chain. Acctrue defines the digital scenario through the unique “ID card” of product identification and forms a fully-connected whole industry chain digital ecosphere between people, people and product and people and enterprise.

Conference calendar:

      It is reported that the “Seminar on Theory and Practice of Drug Safety Traceability System” will be held in China for 5 sessions and started in Shanghai on January 9, 2019. In addition to the government and pharmaceutical enterprises, representatives from pharmaceutical circulation and retail enterprises will participate in the conference. For more information on the latest development of the conference, please keep an eye on us.