MEA 溯源

驾驭监管格局:中东亚洲监管中心及相关链接

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

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.

Qatar

Qatar is at the forefront of pharmaceutical supply chain innovation through a comprehensive track and trace system developed jointly by the Ministry of Public Health (MoPH) and the GS1 Qatar Office under the Qatar Development Bank (QDB). This groundbreaking initiative represents Qatar's commitment to establishing a world-class pharmaceutical regulatory framework that ensures drug authenticity, patient safety, and supply chain transparency from manufacturers to end consumers.

Rwanda

Rwanda's pharmaceutical landscape has been revolutionized through the implementation of comprehensive track and trace regulations by the Rwanda Food and Drugs Authority (Rwanda FDA). Established in August 2022, these regulations represent a forward-thinking approach to pharmaceutical security, designed to protect public health while enhancing supply chain transparency and efficiency across the entire pharmaceutical ecosystem.

南部非洲发展共同体

在南部非洲,药品法规正在逐步演变,以增强整个药品供应链的可追溯性、安全性和质量保证。该地区的许多国家正在实施越来越复杂的监管框架,以打击假冒药品,并通过改善供应链的完整性来确保患者安全,其中许多国家都参与了南部非洲发展共同体(SADC)。 南共体区域由15个成员国组成(安哥拉、博茨瓦纳、刚果民主共和国、莱索托、毛里求斯、马达加斯加、马拉维、莫桑比克、纳米比亚、塞舌尔、南非、斯威士兰和坦桑尼亚联合共和国(大陆和桑给巴尔)。 来源-https://tis.sadc.int/english/sarn/about-sarn/

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