China Regulatory Compliance

General Overview

On June 23, 2022, the National Medical Product Administration (NMPA) issued two standards, NMPAB/T 1011-2022 “Identification Specification for Drug Traceability Code” and NMPAB/T 1012-2022 “Display Specification for Consumer Query Results of Drug Traceability”. It is aimed to promote the construction of drug information traceability system, and guide drug marketing license holders and manufacturers to carry out drug traceability code identification and drug traceability consumer query results display from the perspective of technical implementation. The “Specifications for Drug Traceability Code Marking” was implemented from June 23, 2023, and the “Specifications for Displaying the Results of Drug Traceability Consumer Inquiry” was implemented from the date of issuance.

china track and trace medicines

Barcode Requirements

Currently two coding system are still issued in China – the global GS1 standard and the Electronic Drug Monitoring Code (EDMC) standard that is unique to China:


  • GS1 standards using a GTIN as product code with the required set of AIs, all embedded in a 2D Data Matrix;
  • EDMC – AliHealth eCode: a 20 digits code (7 digits product ID + 9 digits serial number + 4 digits check digits) given by AliHealth and embedded in a 128 barcode;


Current activities to move forward with the use of GS1 standards.

Discover how SoftGroup can help you to achieve China Track & Trace compliance

View Solutions