In recent years, with the international development of Chinese medicine and frequent issuance of regulatory policies, the digital development of Chinese pharmaceutical industry is gradually accelerated, digital production has become an important link in the whole pharmaceutical industry chain, and the deployment of “drug traceability system” plays a key role in production and marketing scenarios.

Not long ago, Xie Zhaohui, Chairman and CEO of Acctrue Technology, accepted a depth interview by China Pharmaceutical News, in which they jointly reviewed the changes in the internal and external environment of the drug and medical device industry in recent years, and conducted in-depth discussions on 「building an integrated traceability platform to energize enterprise digital transformation」. The interview also focused on the bottlenecks in the construction of a drug information traceability system, the necessity of implementing medical device UDI, and Acctrue solutions, hoping to provide you with some inspiration.

The following is all contents of the interview:

(Q is question from China Pharmaceutical News, and A is answer from Xie Zhaohui, President and CEO of Acctrue Technology.)

Q1: In recent years, the pharmaceutical industry has accelerated its digital transformation, and the construction of an information traceability system for drugs, vaccines, and medical devices has been continuously sped up. According to years of deep cultivation in the industry, what do you think are the key points and difficulties in building a drug information traceability system?

A: As a traditional industry, drug and medical device industry has a complex and long business chain, and the whole process of business chain is subject to strict review and supervision on policies. The following three key points need to be focused on:

The first is the production coding link, to ensure the authenticity and accuracy of data, including the data accuracy of packing material coding link, as well as the accuracy and preciseness of the construction process of establishing drug associations and generating master data. This is the core link.

The second is the building of traceability system, to energize the digital transformation of enterprises: the drug information traceability system is the foundation for the digital transformation of enterprises, which shall not only meet the minimum regulatory requirements of the state, but also be available, advanced and expandable, so as to enable the full-link digital management of production and circulation of pharmaceutical enterprises, and promote the digital transformation of enterprises.

The third is the building of a whole-industry chain digital ecosystem, to open up the industry chain all key roles and business scenarios in the industry chain, from suppliers, production factories, distribution enterprises to hospitals, pharmacies, doctors and patients, through a digital platform, forming a complete closed-loop of industry chain.

Understanding the key points is the first step, and there are generally four difficulties:

1. Multi-code coexistence management: for example, the mixed production line of exported and domestic drugs shall comply with both the regulatory requirements of the national traceability system and the international requirements for exports. Another example is the mixed management of drugs and medical devices. How to simultaneously complete the compliance filing and unified management on drugs and medical devices with different coding standards.

Acctrue Technology has provided a solution to this difficulty. In terms of exported drugs, conduct digital transformation of production links as well as transformation of old systems to align with the data requirements of building an international standard drug traceability system; in terms of the traceability of both drugs and medical devices: establish a traceability platform for tracking both drugs and medical devices.

2. GS1 production line transformation: enterprises need to make appropriate upgrades and adjustments. Currently, many enterprises have begun to upgrade and transform to align with international regulatory standards.

3. Opening up of supply chain traceability: first, opening up from the circulation link to hospital and pharmacies, and second, opening up from domestic to foreign traceability platforms. How to realize data collection and correlation throughout the whole link, and ensure its authenticity, accuracy, and traceability?

4. Limitation of electronic supervision code: currently, most domestic pharmaceutical enterprises still use domestic local coding standard, that is, electronic supervision code. However, this standard system faces difficulties in opening up downstream links such as hospitals, pharmacies, and medical insurance platforms.

Acctrue can overcome the above difficulties step by step. Regarding the first point: Acctrue Technology has already opened up each link from circulation to hospitals, including medical insurance, with GS1 standard, and completed the code scanning transformation of a large number of domestic pharmaceutical enterprises, including SINOPHRAM and China Resources. The upgrade data of information system can be transmitted to the Acctrue Traceability Cloud Platform, expanding from top enterprises to small and medium-sized enterprises, to gradually overcome this difficulty. Regarding the second point: Acctrue Technology has established cooperation with mainstream traceability platforms abroad (SAP, Tracelink, EU-HUB, etc.) to achieve one-stop data connection.

Q2: As an enterprise that has been at the forefront of drug traceability for over a decade, what are the advantages of Acctrue Technology in drug traceability?

A: We think Acctrue Technology has overall advantages at the enterprise level include the following eight points:

1. Deeply engaged in the industry: Acctrue Technology has been a major participant in the building of national drug traceability system. Since China began to promote electronic drug supervision in 2006, we are the first to complete the transformation of drug electronic supervision production line. Up to now, we have served over 3000 global pharmaceutical enterprises, including over 60 foreign pharmaceutical enterprises, accounting for over 90% of market share, covering more than 20 countries and regions including China, the United States, the European Union, India, Japan, South Korea, Hong Kong, Taiwan.

2. Technical advantages: in the field of traceability, we have over 50 core technology patents and 100 software copyrights. Moreover, Acctrue is a specially-invited expert in the field of drug and medical device traceability by the National Medical Products Administration, and has participated in the development of multiple relevant traceability standards and continuously provided opinions and suggestions to government departments over the years.

3. Industrial advantages: Acctrue Technology has built a Sci-Tech Park (R&D base) in Wuxi, which has four functions: firstly, an intelligent factory to provide customized intelligent hardware products for customers; secondly, based on the high complexity of traceability projects (“integration of optics, mechanics, electronics and computer technology”) and the high demand for engineering talents, we have established a digital institute for whole-industry chain traceability, to realize rapid replication of key talents, strengthen hematopoietic function, and provide strong guarantees for the maintenance and sustainable development of high delivery capacity of the company; thirdly, the test center. Acctrue has engaged in more than 30 subdivisions in different fields such as medicine and health, fast-moving consumer goods, and industrial products. According to the characteristics and requirements of different industries, we have built an running test environment in the Sci-Tech Park, where we do in learning and learn by doing, which not only achieves high-quality talent cultivation, but also provides strong guarantees for steady expansion of Acctrue in more fields; fourthly, operation service center. we have established a first-class operation service team in the Sci-Tech Park, with over 140 people, to provide high-quality service guarantees for our customers.

4. GS1 standard advantages: Acctrue Technology has built the first pharmaceutical industry traceability cloud platform based on GS1 international standards in China - Acctrue Traceability Cloud. This platform not only takes the lead in completing substantive docking with the national drug collaboration platform, provincial bureau platforms, national medical insurance platforms, and pharmacy special drug platforms, but also is the only “third-party traceability platform” in China that meets the GS1 international standard, achieving the opening up of the whole chain from production, circulation, hospitals, pharmacies to patients, including medical insurance.

5. Production line transformation advantages: digital transformation of production line is the most difficult link in the construction of the drug traceability system. Acctrue has been deeply engaged in the field of traceability for 18 years and has successfully transformed over 20000 production lines, accumulating rich experience in product line transformation. In addition, Acctrue has global production line delivery capability, and we have successfully completed over 50 international projects in over 20 countries and regions around the world.

6. “Cloud coding” advantages: Acctrue cloud coding solution can upgrade the traditional coding of optics, mechanics, electronics and computer technology to cloud service. The production line coding data is uploaded in real-time to the cloud, making it convenient for the traceability platform data of enterprise to connect with own private cloud, providing preparation for the opening up of the whole data chain.

7. Global traceability advantages: we have established deep cooperation with overseas third-party L4 platforms such as SAP, Tracelink, EU-HUB, etc. We have the ability to connect with foreign traceability systems for both imported and exported drugs, helping domestic pharmaceutical enterprises go international, and international enterprises enter Chinese market, with the ability for global traceability.

8. Capital advantages: Acctrue is jointly invested by Inotech National Development and Reform Commission Industrial Fund, Tencent and Cowin Capital. We are also the construction unit of the secondary-level node for industrial Internet identification and resolution of the Ministry of Industry and Information Technology, and we completed the acceptance in 2020 and received tens of millions of yuan for rewards and support from the Ministry of Industry and Information Technology.

Q3: What experience does Acctrue Technology have in ensuring the accuracy, timeliness, and effectiveness of data collection, and enabling enterprise data security? Please give practical cases of the solutions provided by Acctrue Technology for pharmaceutical enterprises.

A: The first is qualification endorsement. Acctrue Technology has passed the “three-level protection” certification, which is the highest level of information security certification for non-bank institutions by the state.

The second is government and customer endorsement. Acctrue Technology is a third-party traceability platform recognized by the National Medical Products Administration, has served over 3000 domestic and foreign pharmaceutical enterprises. Many import and export pharmaceutical enterprises, including Xi'an Jassen, AstraZeneca, have chosen us. In terms of exported drugs, we ensure that drug traceability data is safely imported into foreign countries. In terms of imported drugs, taking Xi'an Jassen as an example, our GS1 traceability platform for imported drugs has connected hospitals, national medical insurance departments, and patients, covering more than 160 hospitals, achieving data security guarantees.

The third is the data security mechanism. Acctrue attaches great importance to data security and has established a sound security management system during its 18-year operation. So far, there has been no security incident. We believe that the most important thing to maintain data security is to reduce personnel access to data. For example, in the packing plant, we have established a whole-process closed pipeline from code generation to activation through Acctrue Logo Cloud (CDS) system, and implemented strict operation authority and data authority management. With whole-process encrypted transmission and correlation verification, various measures and means are taken to minimize personnel access to and transmission of data, realizing data anti-disclosure, anti-tamper, anti-destruction and anti-repudiation, and providing full escort for customer data security.

Q4: The increasingly strict supervision of drugs and the diversification of drug circulation channels have brought opportunities and challenges to the development of drug traceability. How will Acctrue Technology seize the opportunity, and what is the next direction and focus of work?

A: First of all, keep up with the national policies, and help the country establish and improve the national drug information traceability system to meet the needs of national supervision tasks and the enterprise compliance. Then, on the basis of supervision compliance, help enterprises establish a real, accurate, and traceable data system, to achieve data connectivity between medicine, medical treatment and medical insurance, and provide foundation for future digital transformation and upgrading of enterprises. Ultimately, help enterprise customers connect with the global supply chain traceability system and provide an integrated one-stop solution.

To achieve the above goals, we have made sufficient preparations: with Acctrue Traceability Cloud as the core, Acctrue Technology has currently established six standard product lines, including Logo Cloud, Coding Cloud, Supply Chain Cloud, Terminal Cloud, Marketing Cloud (Patient Service Cloud), and CDC, which can be combined to form hundreds of different solutions. This is a difficult and long-term right career for Acctrue. We always attach great importance to taking responsibility for every customer and are prepared to serve them for a long time.

Seven questions and seven answers! Why is the implementation of UDI so important

Q5: In recent years, the state has successively issued a number of UDI related policies, and various provinces and cities have also actively given responses to promote related work. Acctrue Technology is one of the enterprises actively implementing UDI. What are the considerations behind the active implementation of UDI? What do you think is the necessity of implementing UDI for medical devices?

A: The unique device identification (UDI) is the “ID card” of medical devices, the “international language” and “common language” of medical devices, and also a global policy trend. Major countries and regions including China, the United States and Europe are actively promoting the construction of the unique device identification system for medical devices. The “one code for one device” UDI traceability system helps to strengthen the full life cycle management of medical devices, not only effectively ensuring the safety of public use of devices, but also helping:

1. Supervision departments: build big data for medical device supervision, so that the source can be checked, the flow direction can be traced, and the responsibility can be investigated, realizing intelligent supervision;

2. Medical device enterprises: improve enterprise management efficiency, and achieve product compliance, serialized data interface, whole industry chain traceability, and patient digital services.

3. Circulation enterprises: optimize and transform modern logistics systems, improve logistics efficiency, and achieve supply chain visualization, transparency, and intelligent management.

4. Medical institutions: strengthen the risk control of clinical use of medical devices, reduce device use errors, and improve the management of consumables in the hospital;

5. Medical insurance department: make medical insurance settlement transparent and combat fraud and abuse.

Medical devices, like drugs, are special consumer goods related to the safety of public life and health, and it is necessary to resolutely safeguard the device safety for patients. Especially for the Class III medical devices, such as pacemakers, vascular scaffolds, joint prostheses, and plastic filling materials. Such implant products have higher risks, and once problems occur, they may bring huge pain to patients. Therefore, special measures should be taken to strictly control and manage them, so as to ensure their safety and effectiveness. Their traceability is very necessary, and the state also attaches great importance to supervision in this regard. It is necessary for us to take long-term consideration and do an in-depth job.

Acctrue's attention to UDI is not only for the consideration of its own development, but more importantly, as a technology enterprise that has been deeply engaged in the industry for 18 years and has followed the reform and growth of the national drug traceability system, we regard the establishment of the pharmaceutical industry traceability system as our own responsibility and hope to continuously contribute our strength and wisdom to the digital transformation and upgrading of the industry. This is also in line with the strategic positioning of Acctrue industry digital development, and we have very good reasons to do it, especially after the state has clear policies and promotion schedule.

Acctrue hopes to help the country build and improve the UDI identified traceability system for medical device products, truly realize the modernization of supervision with information technology, and create a more intelligent medical device supervision system, and help medical device production and operation enterprises, medical institutions and patients solve pain points through a complete set of full-link digital management and digital service solutions, and protect the public with device safety. In this process, our enterprise can also achieve more long-term development.

Q6: What achievements and practices does Acctrue Technology currently have in UDI? How does Acctrue Technology help the UDI implementation in medical device production and operation enterprises? Can you give one or two practical cases

A: As of now, Acctrue Technology has helped more than 100 customers establish a medical device product traceability system based on UDI identification, covering various subdivisions such as in vitro diagnostic reagents, medical beauty products, contrast agents, high-value consumables, low-value consumables, and medical equipment. Typical customers include Huada Biotechnology, Wantai BioPharm, Leadman, Sansure Biotech, HYBIOME, BERPU, Changchun Botai, Bausch & Lomb, etc.

In serving numerous customers, Acctrue pays special attention to exerting our own industry accumulation and advantages, and has established a complete set of digital solutions for medical device UDI compliance and whole industry chain traceability. On the one hand, according to the instructions of national policies, we continuously optimize and improve our solutions to enable UDI to quickly meet national requirements; on the other hand, for more management pain points and digital needs of enterprises (such as product serialized management, anti-counterfeiting and anti-channeling, product recall, warehouse management, terminal digital operation, interface with medical insurance, patient education, and patient services), we not only have digital product lines and solutions for the whole chain, but also have established in-depth cooperation with powerful partners, such as Tencent, so as to always ensure the high expansibility and advancement of Acctrue solutions, and continue to help enterprise digital upgrading.

Bausch & Lomb UDI project is a typical case of tracking both drugs and devices, that is, the two industry subdivided products of drugs and medical devices share an Acctrue Traceability Cloud platform to complete the compliance filing upwards, and uniformly manage the coding servers of different workshops downwards; phase I of the project covers 4 types of medical sodium hyaluronate gel products (auxiliary medical devices for ophthalmic surgery, used in cataract extraction and intraocular lens surgery) with different specifications. While realizing UDI compliance traceability, it also takes into account the needs of drug association and the uploading of stock-out documents to third-party platforms;

In DAAN project, we have fulfilled the customer's demand for compliance traceability of more than 170 types of IVD products, in which the main products are COVID-19 reagents, Influenza A and B detection reagents, tuberculosis reagents, etc. The encoding solution of DAAN GENE is a typical DI+PI, full-process digital encoding solution, including:

(1) Paging of packing materials, automatic printing of Acctrue UDI identification;

(2) On-line automatic acquisition, multi-level association;

(3) Automatic verification and warning removal of identification printing quality;

(4) Stock-in after generator, connecting with ERP to complete scanning and stock-in;

(5) Forming whole process compliance traceability data.

Q7: What are the advantages of Acctrue compared to other UDI implementation enterprises?

A: As a digital operation service provider for whole industry chain traceability, Acctrue Technology has unique advantages compared to other UDI implementation enterprises:

1. The first medical industry traceability cloud platform service provider based on GS1 in China;

2. Manage a variety of products based on the same platform to achieve the coexisting of multiple codes and tracking of both drugs and devices

3. It can be connected to the medical insurance authentication and verification system, open up the hospital HIS system, realize medical insurance premium control, and traceable flow;

4. It can be connected to US GUDID and EU EUDAMED platforms to provide overseas compliance guarantee for export products;

5. We have opened up logistics management systems of major circulation groups such as Sinopharm, Shanghai Pharma, and China Resources, and more than 500 drugs and medical devices distributors are using Acctrue Traceability Cloud;

6. “Acctrue Traceability Cloud” platform has the “three-level protection” certification issued by The Ministry of Public Security

Q8: What are the characteristics and difficulties in implementing medical device UDI or medical device traceability compared to drug traceability? What is Acctrue Technology's next business plan in UDI?

A: There are two characteristics: first is the small batch and many varieties, that is, small in quantity but diverse in variety. Some enterprises may have tens of thousands of varieties, but the quantity of individual products is not large. The second is that medical device enterprises are numerous and scattered, with over 10000 in the country, while pharmaceutical factories are around 4000, but the majority of medical device enterprises are small and medium-sized, mostly adopting manual coding production lines.

The difficulties mainly lies in production, circulation and supervision, and use:

1. Production: it is necessary to allocate product DI reasonably and design UDI label templates for different product categories and packing characteristics. In UDI projects, it often takes a lot of time to complete such work.

2. Circulation and supervision: the UDI data system is not unified, and there are often links in the middle that cannot be collected and traced, resulting in incomplete traceability data chain. Due to the lack of a unified UDI data system in the industry, only production enterprises grasp the corresponding relationship between product information and UDI, while operating enterprises, logistics enterprises, and medical institutions need to establish corresponding databases to use UDI. Traceability and supervision are limited to regions and some participating units, and whole process traceability cannot be achieved.

3. Use: according to relevant statistics, more than 95% of medical device enterprises currently implementing UDI use the GS1 code. However, downstream reading device system may not be compatible with the GS1 QR code, resulting in a higher cost for distributors to replace their devices.

Acctrue has specific solutions and rich implementation experience to address these three difficulties, and can provide comprehensive consultation services; medical device enterprises can use Acctrue Traceability, a unified traceability platform, to collect and trace data in production, circulation, use, and supervision; in the use process, for distributors with a small number of shipment scans, Acctrue can also provide WeChat mini program to achieve cost reduction and efficiency improvement.

For future planning, Acctrue hopes to open up the whole supply chain from production, circulation, terminal use to medical insurance settlement, establish a complete industrial ecology covering suppliers, production and operation enterprises, hospitals, and patients through one code for one item, provide services for patients, and help production enterprises achieve digital transformation and improve their competitiveness.

Getting the attention of the media is the recognition of the scientific and technological strength of Acctrue by the society and the industry, and also an incentive for the future development of Acctrue. Think ahead and integrate advantages to seek a win-win future. Acctrue Technology continues to do difficult, correct, and long-lasting things, and contribute its own strength to the digital development of whole-industry chain traceability!