Taiwan Pharmaceutical Serialization and Track and Trace Compliance

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Global Regulations

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Labelling

Products are required to display information in writing.

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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

Taiwan operates a national pharmaceutical track and trace system under the Taiwan Food and Drug Administration (TFDA). The system requires serialization of pharmaceutical products and electronic reporting of product movements across the supply chain.

The framework was introduced to strengthen drug safety, prevent counterfeit medicines, and improve visibility of medicine distribution throughout Taiwan. The system covers manufacturers, importers, distributors, and pharmacies.

The traceability system requires serialization of pharmaceutical products, standardized barcode identification, and reporting of transaction data to a centralized government platform.

Labelling Requirements 

All regulated pharmaceutical products must carry a GS1 compliant 2D DataMatrix barcode on the secondary packaging.

The barcode must contain the following data elements:

  • GTIN
  • Serial Number
  • Batch Number
  • Expiry Date

The barcode allows each individual medicine pack to be uniquely identified and tracked through the distribution chain.

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

The system supports standardized identifiers for supply chain partners using Global Location Numbers (GLN).

Regulatory Timeline 

2015 – Taiwan Food and Drug Administration introduces the national pharmaceutical track and trace program.

2017 – Serialization and reporting requirements begin implementation across pharmaceutical manufacturers and importers.

2018 – Mandatory serialization and electronic reporting requirements expand to cover pharmaceutical supply chain participants.

2019 onward – Full operational implementation of Taiwan’s national drug track and trace system across manufacturers, importers, distributors, and pharmacies.

Reporting Requirements 

Taiwan Serialization Table
Operation
Data to Report
When to Report
Commission
GTIN, Serial Number, Batch, Expiry
During packaging or before market release
Serialization Upload
Serialized pack information
Before product distribution in Taiwan
Shipment
Sender identifier, receiver identifier, serial numbers or shipment identifiers
Before dispatch to next supply chain partner
Receiving
Shipment identifiers or serial numbers
Upon receipt of product
Distribution
Serial numbers and transaction details
During supply chain transfers
Decommission
Serial number and status change
When product is dispensed, destroyed, or removed
Recall or Investigation
Serial numbers and distribution records
When requested by TFDA

Operational Timelines for Industry 

  • Generate unique serial numbers for each sellable pack during pharmaceutical packaging operations.
  • Print GS1 compliant DataMatrix barcodes on the secondary packaging of each pharmaceutical product.
  • Upload serialized product data to the national track and trace system before products enter the Taiwanese market.
  • Report shipment and distribution events when products move between supply chain partners.
  • Maintain traceability records for product movements across manufacturers, importers, distributors, and pharmacies.
  • Ensure distributors and pharmacies verify product information during receipt and dispensing operations.
  • Provide serialization and distribution records during regulatory inspections or product safety investigations.

Reporting Hub

Taiwan operates a centralized pharmaceutical track and trace platform managed by the Taiwan Food and Drug Administration.

Manufacturers and importers upload serialization data and transaction information to the national traceability system.

Supply chain partners such as distributors and pharmacies report product movement events, enabling TFDA to monitor product flow, verify authenticity, and support recalls or investigations.

Electronic reporting is typically performed through system integration or secure electronic submission.

Aggregation Requirements 

The Taiwanese track and trace framework supports packaging hierarchies to improve logistics and distribution efficiency.

Manufacturers may implement aggregation structures linking individual serialized packs to higher packaging levels such as cases or pallets.

Logistics units may use SSCC identifiers to support shipment tracking across supply chain operations.

Aggregation improves distribution efficiency and simplifies reporting when large shipment volumes are involved.

Common Errors to Avoid 

  • Failure to upload serialized pack data before distributing products in Taiwan.
  • Mismatch between barcode data printed on packaging and uploaded serialization data.
  • Incorrect serial number generation leading to duplicate identifiers.
  • Incomplete reporting of shipment and distribution events.
  • Failure to maintain traceability records required for product recalls.
  • Barcode quality issues that prevent reliable scanning during distribution or dispensing.

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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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