APAC Traceability

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

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

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.

Uzbekistan

In Uzbekistan, the government has established one of Central Asia's most comprehensive pharmaceutical traceability frameworks through the ASL BELGISI digital system. Managed by the national operator CRPT Turon and modeled after Russia's proven Chestny ZNAK platform, this robust regulatory structure demonstrates Uzbekistan's commitment to safeguarding public health and ensuring the authenticity of pharmaceutical products throughout the entire supply chain.

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