MEA Traceability

Navigating the Regulatory Landscape: Central Hub for Middle East Asia's Regulations and Related Links

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

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.

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.

Nigeria

In Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) stands at the forefront of pharmaceutical safety through its ambitious track and trace regulations. Established under Nigeria's commitment to combating substandard and falsified medicines, NAFDAC's traceability framework represents a transformative approach to pharmaceutical supply chain integrity. This comprehensive system aims to provide end-to-end visibility from manufacturing facilities to patients, fundamentally reshaping how pharmaceutical products are monitored and protected throughout Nigeria's healthcare ecosystem.

Azerbaijan

Azerbaijan has emerged as a regional leader in pharmaceutical security through the implementation of its mandatory medicine tracking and tracing system. Under the oversight of the Ministry of Health's Analytical Expertise Center, the country has established a robust regulatory framework designed to ensure complete transparency and accountability throughout the pharmaceutical supply chain. This comprehensive system represents Azerbaijan's commitment to protecting public health by preventing counterfeit medicines and maintaining the highest standards of pharmaceutical integrity.

Bahrain

In Bahrain, the National Health Regulatory Authority (NHRA) establishes comprehensive regulations to safeguard pharmaceutical integrity throughout the supply chain. The NHRA's stringent regulatory framework represents Bahrain's dedication to ensuring medication authenticity, patient safety, and supply chain transparency through advanced traceability and verification systems.

Zambia

In Zambia, the Zambia Medicines Regulatory Authority (ZAMRA) plays a pivotal role in safeguarding public health through comprehensive regulatory measures. ZAMRA's pharmaceutical traceability requirements serve as a cornerstone in the country's commitment to ensuring the authenticity and safety of medicinal products throughout the pharmaceutical supply chain. Based on the Medicines and Allied Substances Act No. 3 of 2013 and subsequent regulations, Zambia has established a robust framework to combat counterfeit medicines and enhance patient safety.

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