亚太地区的可追溯性

驾驭监管格局:亚太地区监管中心及相关链接

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

Indonesia

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

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.

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.

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.

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