China's Track and Trace Regulations Overview

China has had a phased implementation of their track and trace regulations based on therapeutic drug class, with 2013 and 2014 deadlines covering select products on their Essential Drug List. As of China’s final December 31, 2015 deadline, however, all pharmaceutical products will be covered under China’s unique requirements, which include serialization and government reporting.

Serialization and Reporting Highlights

Serialization: In China, all levels of product – unit, bundle, case, pallet – must be serialized with a government-issued number, and aggregation is a regulatory requirement. Pharmaceutical companies must run a query on a Chinese government system in order to initiate and capture the serial numbers, which are then provided to the packaging lines. After the serial numbers have been deployed, manufacturers must report back on product events.

Reporting: There are multiple complications associated with Chinese reporting requirements. First, all reports must be manually uploaded to the China FSDA system by someone in China; the upload cannot be managed remotely from another country. In addition, there is a size restriction of five megabytes for the uploaded report. If you are reporting on a large batch of data, your file size can easily exceed that, in which case you will need to follow strict guidelines on how to split up the file, what header information to assign, and the sequence in which to upload the multi-part report.

How TraceLink Can Help

TraceLink has been supporting our customers for their China initiatives for nearly eighteen months. We have the most proven China solution in the world, and it's being utilized at high scale: to date, more than 20 million serial numbers have been commissioned and reported for China. TraceLink solutions can help manage all of China’s distinctive requirements, including:

  • Receiving serial numbers from the China government, load them into our module, and then enable 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

There are emerging regulations for China around animal health, which will impact any pharmaceutical company who manufactures veterinary drugs. TraceLink will monitor these and other Chinese developments and continue to lead the way in helping businesses navigate this market.

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China at a Glance

Government agency CFDA 
Regulatory scope Serialization; reporting
Product scope All pharmaceutical products
Participants Manufacturers, wholesale distributors, pharmacies
Next deadline 12/31/2015; all pharmaceutical products
Serial # format Government issued 20-digit EDMC code
Reporting flow Manual uploads to China government