China

v. 2.0 – 05/06/17

Serialization Model Track and Trace: moving from a “drug electronic supervision system” to a “drug tracing system” (from central to distributed model)
Governing Body CFDA
Compliance Date
  • December 31, 2015 – All pharmaceutical products included in a national standard for drug serialization and traceability
  • The preceding requirements were suspended in February 2016; revoking requirements of mandatory scanning of electronic supervision code and data uploading. New requirements are pending
Randomization Requirements N/A
Aggregation Requirements N/A
Reporting Requirements No longer required
Data Repositories
  • Central database, provided by AliHealth, was set up for previous government sponsored repository/supervisory system; AliHealth system is not being updated, but remains operational
  • Proposed: Drug distributors must establish a tracing system, ensuring traceability of drug origin, distribution tracked, investigation capability
Saleable Unit Data Carrier
  • January 2017 CFDA notice advises a standard 14-digit drug code as published on the CFDA website:
    • 1-2 digit: “86” (national code)
    • 3 digit: “9” (sector: Medicines)
    • 4-8 digit: Company ID
    • 9-13 digit: Product ID
    • 14 digit: Check digit
  • March 2017: CFDA notice advises linear, 2D, or RFID data carrier (non-GS1 standard)
Saleable Unit HRI Not Specified
Intermediate Package Data Carrier Not Required
Intermediate Package HRI Not Required
Logistics Unit Data Carrier No specific requirements are specified for identification and labeling at the pallet level
Logistics Unit HRI No specific requirements are specified for identification and labeling at the pallet level
Additional Notes

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