A transitional time, marked by lack of clarity and an uncertain road forward.
Originally, China had a phased implementation of their track and trace regulations based on therapeutic drug class, with 2013, 2014, and 2015 deadlines covering all pharmaceutical products. These regulations included unique requirements around serialization and government reporting. However, with regulators now working on new drug quality monitoring requirements, there is much debate on what regulations are actively in effect in China.
In March 2017, the government published a set of decrees, highlighting 3 of previous regulations as being effectively null and void. While a general publication went out to marketplace, there was never a clear directive, specific to supply chain companies, indicating that they no longer needed to follow the regulations. Consequently, most companies doing business in China continue to comply.
All in all, the industry is in an uncertain transition period as the government potentially phases out with original regulations, develops new ones, and works to insure that the proper track and trace infrastructure is in place to support the future plan. Outside of goals and general principles, no draft regulations or technical specifications for the new requirements have been published.
There is, however, a growing belief that from the serialization perspective, the China government may move towards allowing companies to use GS1 standards or their China-specific identifiers, based on widespread industry feedback.
A long history—and proven track record—in market.
TraceLink has been supporting our customers for their China initiatives since 2013. We have the most proven China solution in the world, and it's being utilized at high scale: to date, more than 120 million serial numbers have been commissioned, and more than 3,800 government reports have been created. TraceLink solutions can help manage all of China’s distinctive requirements, including:
- Receiving serial numbers from the China government, loading them into our module, and then enabling any line around the world to request them for production.
- When production is complete, producing reports in the required formats and submitting them to the Chinese government.
- When product is shipped, producing reports in the required formats and submitting them to the Chinese government.
TraceLink will continue to monitor Chinese developments and continue to lead the way in helping businesses navigate this market.