APAC Traceability

Australia's Therapeutic Goods Administration (TGA) serves as the cornerstone of pharmaceutical regulation in the country, operating under the Department of Health and Aged Care. Through rigorous enforcement of the Therapeutic Goods Act 1989 and related regulations, the TGA ensures all therapeutic goods in the Australian market meet exacting standards of safety, quality, and efficacy, thereby safeguarding public health and fostering consumer confidence.

In the vibrant landscape of China's pharmaceutical industry, adherence to traceability requirements is not just a regulatory mandate; it's a commitment to the highest standards of safety and authenticity. Governed by China's Food and Drug Administration (CFDA), the China Work Plan for Pharmaceutical Electronic Monitioring and 2019 Drug Administration Law pharmaceutical traceability requirements have been meticulously designed to ensure the integrity of medicinal products across the supply chain.

India's pharmaceutical industry is governed by various regulatory bodies, and compliance with traceability standards is crucial to ensuring the safety and integrity of medicinal products.

Indonesia's National Agency of Drug and Food Control (BPOM) has established one of Southeast Asia's most comprehensive pharmaceutical traceability systems through its Track and Trace Anti-Counterfeit (TTAC) framework. This robust regulatory mandate demonstrates Indonesia's commitment to combating counterfeit medicines, enhancing supply chain transparency, and safeguarding public health across its vast archipelago nation.

Japan has pioneered a transformative approach to pharmaceutical tracking and traceability through its mandatory Electronic Package Insert (EPI) system. Since August 2021, the Japanese regulatory framework has fundamentally shifted from traditional paper-based documentation to a comprehensive digital ecosystem that ensures real-time access to critical product information while maintaining robust traceability throughout the pharmaceutical supply chain.

In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) is spearheading a transformative approach to pharmaceutical supply chain security through its comprehensive Track & Trace pilot project. This regulatory initiative represents Malaysia's commitment to combating counterfeit medicines, enhancing supply chain transparency, and ultimately safeguarding patient safety across the nation's healthcare ecosystem.