China Medicines Compliance

National Medical Products Administration (NMPA) Traceability Code System

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Global Regulations

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Labelling

Products are required to display information in writing.

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Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

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Aggregation

The packaging hierarchy of products is required to be identified and documented.

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Central repository

The traceability documentation is required to be centralized in a unique system.

Summary

China has developed a national drug traceability framework under the NMPA and the broader regulatory reform embedded in the Drug Administration Law (effective 1 December 2019), requiring serialized identification of pharmaceutical products and traceability of supply chain movements. Though the Chinese system differs in format and rollout timing from GS1-based systems elsewhere, the direction is clear: each pack must carry a trace-code; distributors and pharmacies must capture and report key events; and from 2025 onward full traceability links with the national insurance reimbursement system will enforce compliance.

Labelling Requirements 

  • Each unit pack must carry a Traceability Code (also known as Drug Traceability Code / Drug Identification Code) that uniquely identifies the product.
  • Two parallel code standards are recognised:
    • The legacy “Electronic Drug Monitoring Code” (EDMC) 20-digit scheme (Issued by government contractor).
    • The newer system aligned with ISO/ISO-style standards (e.g., CNDC) and allowing GS1 2D DataMatrix options.  
  • The code must include or be linked to data items such as: GTIN or product-ID, Serial Number, Batch/Lot, Expiry Date, Manufacturing Date, Manufacturer / MAH.  
  • Human readable text must match the machine readable code. Additional consumer-query QR code or web lookup is often required.
  • Aggregation (case/pallet hierarchy) is mentioned in earlier requirements but enforcement and clarity are variable.

Regulatory Timeline 

  • 2010–2015 – Early serialization pilots under EDMC; some mandatory codes on essential drug list.
  • 2019 December 1 – New Drug Administration Law takes effect, providing legal basis for full traceability.
  • 2022 June 23 – NMPA issues standards: NMPAB/T 1011-2022 (“Identification Specification for Drug Traceability Code”) and NMPAB/T 1012-2022 (“Display Specification for Consumer Query Results”).
  • 2023 June – “Specifications for Drug Traceability Code Marking” implemented.  
  • 2025 July 1 – Mandatory code scanning for reimbursement in medical insurance system begins.
  • 2026 January 1 (planned) – Full code collection and upload by all pharmaceutical institutions as per traceability code regulation.  

Reporting Requirements 

Operation
Data to Report / Capture
When to Report / Capture
Serialization / Code Generation
GTIN/Product ID, Serial, Batch, Expiry, Manufacture Date, Manufacturer
At packaging/unit level
Shipment / Distribution
Code activation / scanning event, tracking through supply chain
As goods move/distribute
Consumer Query / Dispensing
Verification of code by pharmacist or patient, sometimes mandatory scan
At point of supply
Reimbursement Validation
Traceability code must be scanned for insurance claim
From 1 July 2025 onward for listed drugs (cisema.com)
Returns / Decommission
Status of serial/code when expired, destroyed or recalled
At the event

Operational Timelines for Industry 

  1. Register with Chinese authorities and select traceability code scheme (EDMC or new standard) prior to production.
  1. Configure GTIN/product code, serial numbering schema, batch/expiry capture in packaging line.
  1. Print machine-readable code plus human readable info on pack.
  1. Build internal aggregation flow (cases, pallets) even if not fully mandated yet.
  1. Report / activate codes as per Chinese regional/distributor system and keep records for at least 5 years. (Chekkit)
  1. Prepare for mandatory scanning by pharmacists and institutions from July 2025 and link to reimbursement systems.
  1. Monitor regional implementation differences (China provinces may impose additional local requirements).

Reporting Hub

  • There is no single central “hub” analogous to EU EMVS or Russia MDLP yet publicly documented; rather China uses a layered traceability code infrastructure and regional/distributor reporting channels. (GS1)
  • The traceability code is used for consumer verification, and from 1 July 2025 the traceability code scanning by institutions will be mandatory for reimbursement under the national insurance system.
  • Manufacturers, importers and domestic distributors must ensure codes are submitted / registered as required by NMPA standards for traceability.

Aggregation Requirements 

  • Aggregation is referenced in earlier Chinese standards (e.g., EDMC scheme) as case/pallet encryption and linking children units to parent.
  • However, the publicly documented enforcement of complete parent-child SSCC-style aggregation is less mature compared to systems like Russia or Saudi. Many sources treat aggregation as “recommended” or evolving.  
  • As a best practice, manufacturers exporting to China should build aggregation capabilities to align with future enforcement waves.

Common Errors to Avoid 

  • Using only linear barcode when Chinese regulations move toward 2D DataMatrix or QR standards.
  • Selecting legacy EDMC code without validating future compatibility with new standard or GS1 format.
  • Serial numbers or code formats not compliant with NMPAB/T 1011-2022.
  • Poor print quality or placement making code unscannable by pharmacist or consumer.
  • Lack of data capture/reporting link to local distributor systems in China’s market.
  • Failing to prepare for reimbursement-linked scanning (from July 2025) causing exclusion from national procurement.
  • Aggregation missing parent-child hierarchy when required by local province or future rollout.

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