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

Map of the asian Continent

驾驭监管格局

本页集中介绍了整个亚太地区的药品合规情况。每个国家条目都包括简短的监管概述和指向更多信息的链接。由于成熟程度和范围各不相同,此处记录了亚太地区的监管格局,以支持对该地区不断变化的药品合规计划的认识和导航。

所有法规

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.

Kyrgyzstan

In Kyrgyzstan, the implementation of robust pharmaceutical track and trace regulations represents a significant step forward in ensuring public health protection and supply chain integrity. The country has adopted a comprehensive approach that encompasses pharmaceuticals, consumer goods, and agricultural products, establishing a sophisticated regulatory framework that aligns with international GS1 standards while addressing the unique needs of the Central Asian market.

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.

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