Trazabilidad en APAC

Navegando por el panorama regulatorio: eje central para las regulaciones de Asia Pacífico y enlaces relacionados

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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

Ministerio de Salud de Corea del Sur

En el dinámico ámbito de la industria farmacéutica de Corea del Sur, el cumplimiento de los requisitos de trazabilidad es la piedra angular de las prácticas farmacéuticas responsables y seguras. El Ministerio de Seguridad Alimentaria y Farmacéutica (MFDS) de Corea del Sur ha establecido normas estrictas para garantizar la seguridad, la autenticidad y la trazabilidad de los medicamentos dentro de la cadena de suministro, centrándose en el sistema de servicios de información farmacéutica de Corea.

Organización Central de Control Normalizado de Medicamentos de la India

La industria farmacéutica de la India se rige por varios organismos reguladores, y el cumplimiento de las normas de trazabilidad es crucial para garantizar la seguridad e integridad de los medicamentos.

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.

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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