CHINA NMPA enables evolution of serialization by confirming the use of GS1 standards
This is where WIPOTEC quality comes into action
The lack of standardized product identification between manufacturers, distributors, and other supply chain partners makes it difficult or indeed impossible to quickly find and identify products, which in turn leads to supply chain shortages, increased risk, product counterfeiting, and diversion. To change the status quo and prioritize consumer safety and the transparency of the global supply chain, not only regulators are interested, but also more and more manufacturers themselves are realizing the potentials of standardized serialization. However, to make the transition to a modern approach possible, manufacturers must overcome considerable implementation challenges, as their success will depend on many different factors.
For manufacturers, this means that in order to comply with the market relevant serialization and traceability regulations, they must be able to encode different sets of data. Especially for CHINA there is a major update now as CHINA NMPA on October, 13th was confirming the use of GS1 standards. The announcement1 was that, if manufacturers want to change coding standards or the traceability system, they can do it per the requirements of the NMPA harmonization platform. In the NMPA article regarding the harmonization platform2 it’s stated that GS1 standards can be used for implementation of NMPA pharma traceability requirements. So especially for exporting companies this is a major chance for a transition from the well-known China eCode to a GS1 Data Matrix approach.
The big advantage is that producers will only have to mark their products with one kind of code, no matter whether they are produced and sold in China or the rest of the world. Both, companies who import to China and companies who produce in China for export, will be able to reduce working steps, machinery and therefore costs. For this reason and to comply with the GS1 standards, the typical pre-printing of eCodes or deploying very basic coding equipment, consisting of stand-alone printers, is no longer sufficient. To be able to take full advantage of such a global standard, it is necessary to implement a solution that not only prints codes but that can also effectively generate, manage, and exchange batch data, including serial numbers. So companies can avoid costly operational disruptions by implementing an interoperable system that offers value beyond just code printing.
Take the opportunity
1. Sources: www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20201013155906186.html