People’s Republic of China

STATUS: PUBLISHED/ADOPTED

Authority: National Medicinal Products Administration (NMPA)

Request Source: Regulations / Guidance

Data Carrier: –

Detail: According to the implementation guide published in 2019, all drugs in the supply chain will be registered in the traceability system in 2022. Serialization and aggregation applications are carried out for drug traceability in the People’s Republic of China. Because the National Medicinal Products Administration has detailed the basic requirements for the pharmaceutical traceability code. Two types of codes are used for drug traceability in China: AliHealth eCode and DataMatrix in the GS1 standard. Newly realized label applications are based on GS1 codes.

  • GS1 2D Code or Proprietary Chinese eCode
  • Serial Number
  • GTIN

Links:

http://english.nmpa.gov.cn/

China Regulations

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