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EDMC or GS1? 3 Keys to Choosing Your China Traceability System Provider

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The China government, the NMPA, has explicitly included two coding choices in the legal foundation of its traceability law. That effectively adds now the option for industry to use the GS1 global coding standard in addition to allowing the legacy EDMC code that was required in the old China compliance regime.

Even a packaging element as seemingly innocuous as coding can have far-reaching implications. GS1 provides a high level of standardization worldwide. For example, the generation of GS1 codes is an open capability, whereas EDMC uses a proprietary algorithm to do that code generation, which can mean an additional step when you're generating the codes.

In addition to the legal and regulatory foundation that the China government and the NMPA have put in place now allowing GS1 coding, manufacturers need to consider not only the legal implications but consider the supply chain, the business implications for their products, and specifically whether downstream entities such as distributors, whether they have the technical and process capabilities to scan the package identifiers and manage the data contained within them. Otherwise, there's a chance that downstream partners will simply be unable to manage or have difficulty managing a manufacturer's products, causing them to get stuck or delayed.

What should you consider when choosing your China traceability system provider?

At present, the third-party traceability systems vary in their abilities to support both formats, which means that a company's compliance reporting strategy is commingled with their coding choice. 

When choosing a traceability system provider, what should you consider? When choosing a traceability system provider, I would recommend looking in at least three areas. The first is that traceability provider's flexibility and capability in supporting a company's long-term coding strategy, whether it be EDMC or GS1, as many customers have expressed desire to migrate to.

Secondly, a traceability provider's experience in complex track-and-trace environments. It's not only about generating the correct reports but also managing the data and the operational triggers behind them.

Thirdly, knowledge and expertise in medicines track-and-track compliance worldwide because we see that supply chains are becoming increasingly global. 

How can TraceLink help you achieve success in China?

TraceLink, who has managed the previous compliance regime, supports EDMC. We also support GS1 because a number of worldwide markets use that coding scheme. That's why companies need to give thought now as to their long-term objectives. We've found that the majority of manufacturers we work with would like to go the GS1 route in the long term.

 

As part of China’s amended traceability law, companies can now use the GS1 global coding standard in addition to the legacy EDMC code that was required in the original China compliance regime.

What should you consider when choosing which format to use—and how does that affect your choice of traceability system provider? In this video, TraceLink’s Director of Industry Marketing and Community, Allan Bowyer, discusses why flexibility, business expertise, and regulatory insight are critical for long-term success in China.

VideoChina PharmaceuticalsGlobal Track & TraceRegulatory/ComplianceChina

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Learn more about TraceLink's China compliance solution.
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