The Industry background

Fake medicines are a global problem. According to the relevant data report of the World Health Organization, the global annual sales of fake medicines are up to 85 billion dollars. In response to this problem, dozens of countries in the world have issued or are planning to issue laws and regulations on medicine traceability. The Drug Quality and Security Act (DSCSA) requires to build up a traceability system for the whole supply chain across the United States by the end of December 2023, and the European Falsified Medicines Directive (FMD) clearly demands to establish a safety file "to verify the authenticity" of each medicine circulating in the EU, as well as a shared database for EU countries to store medicine safety information…

Three major traceability challenges faced by Chinese medicines to go overseas

Regulatory compliance

How to meet the requirements of traceability regulations and standards in different countries?

Data connection

How to connect and transmit data more efficiently with overseas L4 platforms?

Supply chain management

How to realize the refined management of supply chain while meeting the compliance requirements of overseas markets?

L1-L4 one-stop serialized solution for exported medicine

Build a globally compliant medicine traceability and digital management system

Consultation on global traceability regulations

Deeply understand the policies and standards of the pharmaceutical industry to cope with the traceability of the United States, the European Union, South Korea and other countries and regions around the world.

Packaging line GS1 coding association

The GS1 international coding standard is adopted to assign a unique traceability code to each product of minimum sales unit and establish packaging associations at all levels to achieve compliance in the overseas market.

Level4 system interface development

Support the connection with SAP, Tracelink, Rfxcel and many other global third-party digital cloud platforms and customized development of interface according to the relevant data exchange and interface standards, to achieve one-stop data transmission.

Supply chain refined management

Open up the whole supply chain for pharmaceutical industry, eliminate the barriers to data flow in all links, improve the efficiency and transparency of supply chain management, and help the digital transformation and upgrading of supply chain in the pharmaceutical industry.

A number of significant advantages to help Chinese pharmaceutical enterprises "go global”

Strong product architecture

Based on the architecture of "cloud + management + terminal”, Acctrue Coding Cloud is applicable to a variety of serialized coding production lines, and can seamlessly connect with multiple L4 system service providers.

Products with high stability

The high system stability proved by the practice of over 20000 production lines of more than 3000 pharmaceutical enterprises can operate perfectly in high-speed packaging lines.

Rich experience in overseas projects

The Company has branches in the United States to provide cross-border whole-industry chain traceability services for foreign pharmaceutical enterprises and domestic leading pharmaceutical enterprises, and has rich experience in overseas projects.

Excellent service capability

With more than 10 years of rich implementation and service experience in medicine traceability, the Company has a market share of Number 1 in the industry, and has complete solutions for the whole process from consultation, implementation, verification to operation and maintenance.

Serialized customer case for exported medicines

TECHDOW is the largest production base and export enterprise of LMWH raw materials in China. With its strong scientific research strength, leading technology, reliable quality assurance system and excellent industrialization ability, the bulk drug products (enoxaparin sodium bulk drug, etc.) have won the excellent international authoritative qualification certification, and have successively passed the audit of more than 20 countries, including the FDA of the United States, the EMA of the European Union, the FDA of China, the TGA of Australia, ANVISA of Brazil, and INVIMA of Colombia.

Challenges faced by Customer

The laws and regulations of China, the United States and Europe shall be met at the same time.
Group platform management and control, and multi-factory production in different places are implemented, and product data informatization is centralized and complex.
There are many kinds of export products, which need to be equipped with hundreds of product specifications and dozens of packaging sizes.
The requirements for production flexibility are high, and flexible production modes such as "QR code+three dates", "only printing three dates without connection", "manual production when the automatic packaging line cannot be transferred", etc. are required.


Based on the ESC production line coding system, GS1 QR code is printed on each saleable individual unit to realize coding, data acquisition, and establishment of packaging association. 1
With the PDM product data management system, it can effectively collect product production and inbound and outbound data, and upload them to the Tracelink cloud platform.

Project achievements

Regulatory compliance

It complies with the requirements of traceability and supervision of China, the United States, Europe and other places, and becomes the first domestic serialized project of medicines exported to the EU.

Supply chain efficiency improvement

The management value of medicine serialization in the enterprise and supply chain is maximized on the premise of complying with the FDA/CFDA medicine serialization regulations.

Customer testimony

As the first code assignment project facing the EU market in China, in the face of many difficulties and complex challenges, Acctrue Technology has successfully delivered with tenacious spirit and exquisite professional technology, making our company the first domestic company to deliver serialized products to the EU market, and at the same time, we are also in the forefront of European peers.

Cooperation of Acctrue Technology and X TraceLink

Acctrue Technology
Whole-industry chain tracing digital service provider

Serve domestic pharmaceutical enterprises


Top 100 pharmaceutical enterprises


Have successfully transformed more than 20000 production lines


Medical code data processing capacity


A world-renowned medicine traceability solution provider

Serve domestic pharmaceutical enterprises


Partners covered by the traceability network


Serve global customers


Supply chain endpoints


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