Japan Serialization and Traceability Compliance

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Global Regulations

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Labelling

Products are required to display information in writing.

Summary

Pharmaceutical traceability in Japan is regulated by the Ministry of Health, Labour and Welfare (MHLW) under the Pharmaceutical and Medical Device Act (PMD Act). The regulatory framework focuses on ensuring supply chain integrity through standardized product identification and electronic data exchange.

Japan does not currently mandate full unit level serialization and national track and trace reporting similar to systems implemented in the United States or European Union. Instead, Japan has implemented a standardized barcode identification system based on GS1 standards, which enables product identification and traceability across the pharmaceutical supply chain.

The system requires pharmaceutical manufacturers to apply GS1 DataBar or GS1-128 barcodes containing standardized product identification information on medicine packaging. These barcodes allow healthcare providers, wholesalers, and pharmacies to identify medicines and support supply chain verification.

Japan’s approach emphasizes standardized identification and distribution record keeping, supported by electronic information systems used by wholesalers and healthcare institutions.

Labelling Requirements 

Pharmaceutical products distributed in Japan must include standardized barcodes to support identification and traceability across the supply chain.

The secondary packaging and in many cases primary packaging must include a GS1 compliant barcode containing product identification information.

Typical barcode elements include:

  • GTIN or standardized product code
  • Batch or lot number
  • Expiry date

These identifiers are encoded using GS1 DataBar or GS1-128 barcodes depending on the packaging level.

The barcode allows pharmaceutical distributors, hospitals, and pharmacies to scan and verify medicines during distribution and dispensing processes.

Human readable information printed on the packaging must match the encoded barcode data.

Regulatory Timeline 

2006 onward
Japan began introducing standardized pharmaceutical barcoding requirements to support supply chain identification.

2015
Japan expanded barcode requirements to include additional packaging levels and standardized identification codes.

Current Status
Japan continues to maintain a barcode based traceability framework without mandatory serialization or centralized reporting.

Reporting Requirements 

Operation
Data to Maintain
When to Record
Product Identification
Product code, batch number, expiry date
During packaging
Shipment Documentation
Product identifiers and shipment details
During distribution to wholesalers
Distribution Records
Product movement between supply chain participants
During transfers
Receiving Records
Product identification and receipt confirmation
At warehouse or healthcare facility receipt
Recall Management
Product batch identification
During recall or safety investigation

Supply chain participants must maintain accurate records that allow regulators to trace products through distribution channels.

Operational Timelines for Industry 

  • Apply GS1 compliant barcodes containing product identification data during packaging.
  • Ensure barcode placement meets Japanese pharmaceutical labeling requirements.
  • Maintain electronic distribution records across the supply chain.
  • Enable barcode scanning capabilities across wholesalers, pharmacies, and healthcare institutions.

Reporting Hub

Japan does not operate a centralized national pharmaceutical serialization reporting platform.

Traceability is maintained through electronic data exchange between supply chain participants, including manufacturers, wholesalers, hospitals, and pharmacies.

Pharmaceutical wholesalers play a significant role in maintaining distribution traceability by recording product movements and maintaining supply chain records that can be inspected by regulatory authorities.

This decentralized model allows regulators to trace medicines through supply chain documentation when necessary.

Aggregation Requirements 

Japan does not mandate aggregation of pharmaceutical products for regulatory traceability purposes.

Aggregation may be implemented internally by manufacturers and distributors to support logistics automation and warehouse management, but this is not required by Japanese pharmaceutical regulations.

Common Errors to Avoid 

  • Incorrect formatting of GS1 barcodes used for pharmaceutical identification.
  • Missing barcode information on required packaging levels.
  • Failure to maintain distribution records required for regulatory inspections.
  • Mismatch between encoded barcode data and printed packaging information.

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LSPedia didn’t just provide software; they ensured we were fully compliant. Anytime we had questions, the LSPedia team knew DSCSA inside and out and guided us step by step. That level of expertise made a huge difference during audits. Thanks to their expert team our audit was smooth and successful

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Lead Pharmacist, Pioneer Pharmacy Services

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EPCIS Data Encoder,Capital Wholesale Drug
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