APAC Traceability

Navigating the Regulatory Landscape: Central Hub for Asia Pacific's Regulations and Related Links

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Navigating the Regulatory Landscape

This page offers a centralized view of pharmaceutical compliance across the Asia-Pacific region. Each country entry includes a short regulatory overview and a link to further information. With varying levels of maturity and scope, APAC regulatory landscapes are captured here to support awareness and navigation of evolving pharmaceutical compliance initiatives across the region.

All Regulations

Malaysia

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.

Pakistan

Pakistan has established a robust regulatory framework for track and trace systems, spearheaded by the Drug Regulatory Authority of Pakistan (DRAP) and the Federal Board of Revenue (FBR). These comprehensive regulations, particularly SRO 470(I)/2017 for pharmaceuticals and the broader FBR Track and Trace System, represent Pakistan's commitment to combating counterfeit products, enhancing tax compliance, and ensuring supply chain transparency across critical sectors including pharmaceuticals, tobacco, cement, sugar, and fertilizers.

Philippines

In the Philippines, the Food and Drug Administration (FDA) has established a comprehensive track and trace system designed to enhance pharmaceutical security and combat counterfeit products. Through FDA Circular No. 2014-011 and subsequent regulations, the Philippines demonstrates its commitment to protecting public health by implementing robust traceability measures that ensure product authenticity and safety throughout the pharmaceutical supply chain.

South Korea

In the dynamic realm of South Korea's pharmaceutical industry, compliance with traceability requirements is a cornerstone of responsible and secure pharmaceutical practices. The Ministry of Food and Drug Safety (MFDS) in South Korea has established stringent regulations to ensure the safety, authenticity, and traceability of medicinal products within the supply chain centered on the Korea Pharmaceutical Information Service system.

Sri Lanka

The National Medicines Regulatory Authority (NMRA) of Sri Lanka stands as the cornerstone of pharmaceutical safety and quality assurance in the island nation. Established in 2015 through an Act of Parliament, NMRA serves as an independent authority under the Ministry of Health, dedicated to protecting public health by ensuring that all medicinal products, medical devices, and borderline products meet stringent standards of safety, efficacy, and quality throughout the pharmaceutical supply chain.

Taiwan

Taiwan has established one of Asia's most robust pharmaceutical traceability systems, anchored by the Pharmaceutical Affairs Act and comprehensive regulatory oversight. The Taiwan Food and Drug Administration (TFDA) enforces a "full track and trace" system that monitors pharmaceutical products through every stage of the supply chain, from manufacturing to patient delivery. This systematic approach demonstrates Taiwan's unwavering commitment to pharmaceutical safety, supply chain transparency, and public health protection.

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