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China eCode or GS1 Encoding? Weighing the Benefits and Risks

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Learn more about TraceLink's China compliance solution.
October 8, 2020

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I mentioned before that with the new version of China regulations, the law has provided two options. The traceability report structure does support both formats.
TraceLink supports both formats. We have used the eCode for the previous version of our China solution. Since we have a rather extensive set of solutions for other countries, we handle GS1 standards there as well. I want you to understand what the options are, but also there are some implications there.

Going back to the first version, we had the eCode. That is a 1D or linear barcode that was put on each product. It's proprietary, not aligned with GS1 standards. There was a lot of work between GS1 and industry with China and the NMPA, to allow the GS1 standard. Now, many companies prefer GS1 because of the global harmonization. As I said, manufacturers are using GS1 and other regimes. Many of their lines and hardware are tooled for using GS1. One consideration for China is whether your downstream trade partners—wholesalers, pharmacies, and hospitals—would be able to read the GS1 codes.

In addition, we've learned that at that third tier, where you're selecting your traceability provider, some providers offer support for just one of these coding schemes. You, as a company, need to decide. But you don't need to make one blanket decision. You can make a decision per product on how you want to encode them. I'd say the tier-three selection is tied also to your coding strategy, so just keep that in mind as you're selecting a provider.

Finally, there are some questions as to whether, if you start with one code—let's say for this December deadline—if you would be stuck using it, or if that coding is on a per batch level. We're waiting for some clarification from the NPMA on that. Not all questions on coding have been answered, but I hope to give you at least a flavor and some awareness of the discussion.

Since 2015, China’s track and trace regulations have specified that products be identified using the 20-character Chinese eCode standard. In 2019, the guidelines were amended to include a second encoding option that conforms to the GS1 coding standard used by manufacturers to meet traceability regulations in markets around the world.

Which one is right for you? Watch this short excerpt from our recent webinar, China's Technical Requirements and Compliance Deadlines: What You Need to Know Now, to learn more and to understand key considerations for making the right choices.

Basics,
China,
Pharmaceutical
More China Compliance Resources
China Reporting and Compliance Systems: Key Considerations
What makes China compliance so challenging? Watch this brief overview of China’s 3-tier reporting system to help guide your China serialization strategy.
China Compliance: Systems and Standards at a Glance
This infographic provides an overview of the key requirements of China’s track and trace law so you can begin your serialization and compliance planning now
Are Your Products China Ready? Three Key Decisions for Multinational Pharma Companies
China's drug administration law and serialization framework for medicines could affect your China product packaging strategy. Learn how today.
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