How China's Serialization Move Impacts Global Traceability

By Lori Clapper, Editor

In February, China’s State Food and Drug Administration (SFDA) announced its implementation of a national track-and-trace strategy, leaping ahead of the United States in national serialization efforts. The agency felt its current good supply practices (GSPs) weren’t on pace with the rapid growth of China’s economy and society, not to mention evolving drug regulatory and pharmaceutical distribution requirements. Regulators revised the GSPs to provide much-needed clarity through a three-year implementation plan that begins June 2013. So, what do these provisions mean to U.S. and global track-and-trace endeavors? To find out more, I talked with Michael Stewart, VP of track-and-trace projects for PharmTech, Inc., a consulting group that has been involved in serialization projects with pharmaceutical manufacturers since the development of the California ePedigree mandates.

The Great Global Serialization Debate
With China’s adoption of a national track-and-trace solution, Stewart says the country now faces follow-up challenges. He believes the first concern is whether China’s focus on a standardized product identification approach will work together with other global formats. Second, will the GSP changes actually enable seamless sharing of product information and cross-border movement of products? “China’s adoption of a national track and trace solution, rather than a globally harmonized one, adds yet another piece to the competing patchwork of traceability requirements globally,” he added. “These measures were drafted independent of the US (California) mandates and without consideration of the guidelines published by their regional counterparts through the EFPIA and EU’s Falsified Medicines Directive. As an example, China’s issuance of its own government-issued national-product identifiers (EDMC [Electronic Drug Monitoring Code]), rather than supporting and adopting a global standard, like GS1, for product identification and hierarchy (GTIN, GLN, SSCC).”

“Although we applaud China for taking measures to safeguard its pharmaceutical supply chain, now the global discussion should not be whether item-level serialization should occur, because that’s a given,” Stewart explained. “Rather, the questions that should be asked are: What are we trying to accomplish? Is ePedigree or authentication the end goal, and why?” For example, in the United States and California, ePedigree essentially identifies counterfeit drugs that have infiltrated the legitimate supply chain and eventually tracks where they were introduced into the supply chain and by whom. Unfortunately, that doesn’t always solve the problem. “As we’ve seen in the Avastin incidents this past year, there have been physicians and pharmacists who have purchased medications from online pharmacies and gray markets outside of the legitimate supply chain, to save a few bucks,” he added. This is where China’s authentication methods come into play. The authentication process checks the validity of the serial number at the point the drug is dispensed to the patient, not during its travels. Wouldn’t the best solution be a hybrid of both, where fake products could not enter the supply chain and also could be detected at the point of dispense? Sure, but Stewart emphasized that “we need to ensure that the cost of the solution is not more costly than the problem.”

Geography is also another issue, since less than .5% of dispensed medications in developed countries are counterfeit and 10% to 30% are counterfeit in emerging markets. In response, developing countries have introduced their own low-cost authentication solutions through the use of cell phones, bringing about a global “patchwork effect” for track and trace, rather than a harmonized solution. “Just because it rains in China does not necessarily mean that the entire North American continent or Europe should go buy umbrellas,” Stewart joked. However, he emphasized the importance of matching the serialization solution with geographic risk, even though that could go against the thought of global mandates, as in the changing requirements in China.