China Serialization requirements
| Regulatory Agency |
National Medical Products Administration (NMPA) — China’s central
regulatory authority responsible for drug safety, pharmaceutical
standards, and traceability system implementation, mandated under the
Drug Administration Law.
|
| Regulation Name |
- NMPAB/T 1011-2022 — 药品追溯码标识规范 (Identification Specification for Drug Traceability Code) — Sets traceability code requirements (format, placement, structure). Effective June 23, 2023.
- NMPAB/T 1012-2022 — 药品追溯消费者查询结果显示规范 — Defines how traceability info must be presented to end users.
- Earlier informationization standards such as Guidelines for Drug Informationization Traceability System Construction (2019) provide foundation for traceability systems.
- Traceability system is underpinned by China’s Drug Administration Law and follow-on policy documents.
|
| Compliance Dates |
- June 23, 2023: Implementation of NMPAB/T 1011-2022.
- July 1, 2025: Traceability code scanning becomes mandatory for settling medical insurance claims.
- January 1, 2026: Full traceability code collection and upload by medical institutions required nationwide.
|
| Applies to |
Mandatory to print QR codes on all the Active Pharmaceutical Ingredients
(APIs) or bulk drugs manufactured or imported in India.
|
Secondary Packaging
(A carton containing one or more primary packs and includes a “mono carton”
containing one primary pack)
| Barcode Symbology |
Linear, or 2D Datamatrix following GS1 standards |
| Barcode Contents |
China traceability codes are unique identifiers printed on
product packaging and may be encoded as:
- A 20-digit traceability code comprising a product identification portion and a serial number portion.
- GS1 standard DataMatrix codes including GTIN, batch/lot, expiry, and serial components (increasingly prevalent especially for imported products)
|
| Serial Number Randomization |
No |
| Serial Number Reuse |
Not Specified |
| Human Readable Expiry Date Format |
The expiry date in human-readable form should be presented in the
YYMMDD format
|
| Barcode Data Encoding |
Codes may be printed in linear or 2D formats (based on China standards
and GS1)
|
| Product Code Notes |
Traceability codes link product, batch/serial information, and origin
details in a single unique identifier
|
| Free Samples must be marked? |
Current regulations do not explicitly require marking free samples with
traceability codes, though practically any commercially distributed unit
subject to traceability should carry a trace code. (Industry practice
rather than explicit government text)
|
Tertiary Packaging
(A shipper containing one or more secondary packs)
| Barcode Symbology |
GS1-128 linear |
| Barcode Contents |
GS1-128 (SSCC)Tertiary packaging such as cartons may use linear
Code128 or SSCC with traceability info, depending on
implementation scope.
|
Aggregation Data Capture
|
Parent-Child Mapping Aggregation Capture? |
Parent-child relationships between packaging units can be recorded for
supply chain traceability, though underlying standards focus primarily
on item-level codes.
|
Data Exchange
|
Send Unit Data to Government Repository?
|
Required via national traceability insurance platform integration.
|
|
Send Unit Data to Third-Party Repository?
|
Not standard; government system is primary. (No official requirement
found)
|
| Send Unit Data to Trading Partner? |
Not explicitly mandated at item level in public texts.
|
|
Send Aggregation Data to Government Repository?
|
Increasingly encouraged but specific mandates vary by sub-regulation.
|
|
Send Aggregation Data to Third-Party Repository?
|
Aggregation data to third-party repositories: Not Specified / No
regulatory mandate
in Chinese national rules
|
|
Send Aggregation Data to Trading Partner?
|
Aggregation data exchange to trading partners: Not Specified / No
regulatory mandate
in Chinese traceability compliance texts.
|
Authentication
|
Who Offers Data Repository for Authentication?
|
The primary data repository for authentication and traceability
in China is managed by the
National Medical Products Administration (NMPA)
|
|
Manufacturers Must Register Shipments in Repository?
|
Yes |
|
Downstream Trading Partners Must Authenticate on Receipt?
|
Yes
|
|
Downstream Trading Partners Must Authenticate on Shipment?
|
Yes |
Government Reporting
| Manufacturer Activity Reported? |
Yes, coded events (production, scanning, etc.) are captured.
|
|
Downstream Trading Partner Activity Reported?
|
Scanning events entered by hospitals/pharmacies must upload to system.
|
