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

Turkish iTS

Step into the future of pharmaceutical compliance with confidence by embracing the Turkish Pharmaceutical Track and Trace System (iTS). Complying with the iTS is not just a regulatory necessity; it's a strategic imperative to ensure the safety, transparency, and integrity of your pharmaceutical operations in Turkey.

United Arab Emirates

The United Arab Emirates has positioned itself as a regional leader in pharmaceutical security through the implementation of one of the world's most advanced drug traceability systems. Spearheaded by the Ministry of Health and Prevention (MOHAP), the UAE's comprehensive regulatory framework centers around the Tatmeen platform—a sophisticated digital ecosystem designed to ensure complete transparency and security across the pharmaceutical supply chain. This cutting-edge approach not only safeguards patient welfare but also establishes the UAE as a benchmark for pharmaceutical regulatory excellence in the Middle East.

Saudi Arabia

The Kingdom of Saudi Arabia has established itself as a regional leader in pharmaceutical regulation through the Saudi Food and Drug Authority (SFDA). With a commitment to safeguarding public health, the SFDA has implemented comprehensive regulatory measures that align with international best practices while addressing the unique needs of the Saudi healthcare landscape. These stringent requirements ensure that all pharmaceutical products meet the highest standards of quality, safety, and efficacy before reaching patients.

Egypt

Egypt has established a comprehensive regulatory framework for pharmaceuticals through the Egyptian Pharmaceutical Track & Trace System (EPTTS), overseen by the Ministry of Health and Population. This pioneering initiative represents Egypt's commitment to safeguarding public health by ensuring the authenticity, safety, and traceability of medicinal products throughout the entire pharmaceutical supply chain.

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.

Ethiopian EFDA

In Ethiopia, the Ethiopian Food and Drug Authority (EFDA) plays a pivotal role in ensuring the safety, efficacy, and quality of pharmaceuticals. Central to its regulatory framework is the EFDA Traceability Directive, a comprehensive set of requirements designed to bolster the traceability of medicinal products within the pharmaceutical supply chain.

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