Central Hub for Asia Pacific

Australia regulates medicines through the Therapeutic Goods Administration (TGA). The country does not currently operate a national pharmaceutical serialization and verification system similar to those implemented in the European Union, Türkiye, or the United States.

The Australian regulatory framework focuses on product identification, supply chain documentation, and compliance with Good Manufacturing Practice and Good Distribution Practice. These controls support medicine traceability, product recall management, and protection against counterfeit medicines.

Manufacturers, importers, sponsors, wholesalers, and pharmacies must maintain clear records of product distribution and ensure medicines supplied to the Australian market are properly identified and traceable throughout the supply chain.

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.

Indonesia is evolving toward full pharmaceutical traceability under the oversight of BPOM (National Agency of Drug and Food Control). The country currently mandates GS1 barcode identification for medicines and is building a national reporting model that requires supply chain actors to register products, submit batch information and maintain traceability records.

While Indonesia has not yet reached full real time serialization reporting like CIS or GCC countries, the system is moving in that direction. Importers and manufacturers must meet strict GS1 labeling and product registration standards to ensure market access.

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.

Pharmaceutical products in Malaysia are regulated by the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health Malaysia. Malaysia has implemented a national pharmaceutical verification and traceability initiative to improve supply chain transparency and prevent counterfeit medicines.

Malaysia operates the Pharmaceutical Track and Trace System (Pharma T&T), which requires pharmaceutical products to carry GS1 compliant DataMatrix barcodes with serialized identifiers. The system enables tracking and verification of medicines throughout the pharmaceutical supply chain.

The Pharma T&T framework supports digital reporting of medicine movement from manufacturers and importers through distributors to pharmacies. The system aims to improve regulatory oversight, protect patients from falsified medicines, and strengthen the integrity of the pharmaceutical supply chain.

Implementation has been phased, with serialization requirements initially applied to selected pharmaceutical products and progressively expanded.

South Korea enforces serialization and supply chain visibility through the Korea Pharmaceutical Information Service (KPIS) operated by the Ministry of Food and Drug Safety (MFDS). All prescription medicines and many OTC products must be serialized and reported across the supply chain.

Reporting focuses on traceability using GS1 standards, shipment-level visibility and real time updates for critical movements. Manufacturers, importers and distributors must follow strict timelines to avoid compliance penalties.