Trazabilidad MEA

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

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Navigating the Regulatory Landscape

This page provides a consolidated overview of pharmaceutical regulations throughout the Middle East and Africa. Each listed country presents a brief description of its regulatory framework, with direct access to more in-depth details. The hub is designed to clarify diverse compliance expectations across MEA, highlighting both emerging requirements and established standards in the region.

All Regulations

ITS turcos

Adéntrese en el futuro del cumplimiento farmacéutico con confianza adoptando el Sistema de seguimiento y localización (iTS) de Turquía para productos farmacéuticos. El cumplimiento de los ITs no es solo una necesidad normativa; es un imperativo estratégico para garantizar la seguridad, la transparencia y la integridad de sus operaciones farmacéuticas en Turquía.

Iraq

Iraq has established a comprehensive pharmaceutical regulatory framework through its National Drug System (المنظومة الوطنية للدواء), administered via the Gudea portal. This pioneering digital platform represents Iraq's commitment to enhancing drug safety, combating counterfeit medications, and ensuring complete transparency throughout the pharmaceutical supply chain. The system mandates rigorous tracking and tracing protocols for all pharmaceutical products, whether domestically manufactured or imported, creating an integrated ecosystem that protects patients while supporting regulatory oversight.

Lebanon

Lebanon's Ministry of Public Health (MoPH) has implemented the MediTrack system as a comprehensive pharmaceutical traceability solution designed to safeguard public health and ensure medicine authenticity throughout the supply chain. This GS1-compliant track and trace system represents Lebanon's commitment to combating counterfeit medicines, preventing diversion, and maintaining transparent pharmaceutical distribution from manufacturing to patient dispensing.

Libya

Libya has established a robust regulatory framework that encompasses both pharmaceutical product serialization and comprehensive cargo tracking systems. Through the Ministry of Economy and Commerce's Decision No. 379 of 2023 and the implementation of the Advance Cargo Information (ACI) system, Libya demonstrates its commitment to enhancing product safety, combating counterfeiting, and strengthening customs oversight across all imported goods.

Nigeria

En Nigeria, la Agencia Nacional para la Administración y el Control de Alimentos y Medicamentos (NAFDAC) está a la vanguardia de la seguridad farmacéutica a través de sus ambiciosas normas de seguimiento y localización. Establecido en virtud del compromiso de Nigeria de combatir los medicamentos falsificados y de calidad inferior, el marco de trazabilidad de la NAFDAC representa un enfoque transformador para la integridad de la cadena de suministro farmacéutica. Este sistema integral tiene como objetivo proporcionar una visibilidad de principio a fin, desde las instalaciones de fabricación hasta los pacientes, modificando radicalmente la forma en que se controlan y protegen los productos farmacéuticos en todo el ecosistema sanitario de Nigeria.

Oman

In the Sultanate of Oman, pharmaceutical safety and quality are overseen by the Ministry of Health through specialized directorates that maintain rigorous standards for drug registration, distribution, and compliance. Oman's pharmaceutical regulatory system emphasizes patient safety while aligning with international best practices, creating a robust framework that governs every aspect of the pharmaceutical supply chain from registration to retail distribution.

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