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Acctrue Technology assists Hengrui Medicine to establish the information traceability system that conform to the traceability laws and regulations in Europe and the United States
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Release time:2017-02-17

   Recently, Hengrui Medicine cooperated with Acctrue Technology again so as to ensure that drug exported to the United States can meet the local requirements for GS1 standard code system and establish the information traceability system conform to the GS1global quality management standard.

 

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   Founded in 1970, Hengrui Medicine is committed to the innovative development of fields such as antineoplastic drug, surgery drug, contrast medium, cardiovascular drug and anti-infectious agent, gradually owns the brand advantages, becomes the largest research and production base of antineoplastic and surgery drug and one of the most innovative and largest pharmaceutical enterprises and rated as the "advanced collective of national pharmaceutical system" and one of the top ten benefit enterprises in chemical pharmaceutical industry by the State Statistics Bureau for many years. In addition, Hengrui Medicine is also the first pharmaceutical enterprises that is approved to sell injection in European and American markets, and the 3 injections, 2 solid preparations and 5 bulk drug have been certified by FDA and EU.5FDA

 

   According to the laws and regulations, the drug of Hengrui Medicine shall be approved by FDA and conform to the local laws and regulations before sales in American market. It is reported that the United States formally promulgated Drug Supply Chain Security Act (DSCSA) in 2013, clearly defined the legal requirements and schedule and required that the whole supply chain traceability system should be established in the United states by the end of 2023. The laws and regulations require that all drug exported to the United States from China shall be printed with readable code and 2D data matrix and conform to the GS1 standard. During this cooperation, Acctrue Technology not only provides the legal GS1 code system standard based on its experience in drug tagging and traceability field for dozens of years and the deep understanding on global pharmaceutical laws and regulations, but also assists Hengrui Medicine to establish the information traceability system that conform to the global laws and regulations. Liu Wenxin, the senior consultant of Acctrue Technology, introduced, “We have established the BizTTS product quality traceability system that has the independent intellectual property, applicable to the traceability requirements and government laws and regulations of many countries such as China, the United States, Korea and EU, fully meets the requirements of information system such as GMP/GSP, 21 CFR Part 11 and Annex 11, and can generate codes (code 128, GS1, SGTIN and SSCC) or customize the format to support QR code according to different business demands and code system standards of enterprises.”

 

   With the globalization of drug market economy and supply chain, it is an industrial standard/mandatory law/regulation to establish the traceability system for all pharmaceutical enterprises in the world and the global pharmaceutical supply chain. In order to expand the trade territory in the future, pharmaceutical enterprises shall have own traceability system to cope with other national regulations. Therefore, Acctrue Technology is committed to providing one-stop integrated solution for all enterprises.