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

SADC

In Southern Africa, pharmaceutical regulations are progressively evolving toward enhanced traceability, safety, and quality assurance across the pharmaceutical supply chain. Countries in this region, many of which participate in the Southern African Development Community (SADC), are implementing increasingly sophisticated regulatory frameworks to combat counterfeit medications and ensure patient safety through improved supply chain integrity. The SADC region is made up of 15 Member States (Angola, Botswana, Democratic Republic of Congo, Lesotho, Mauritius, Madagascar, Malawi, Mozambique, Namibia, Seychelles, South Africa, Swaziland and United Republic of Tanzania (Mainland and Zanzibar). Source - https://tis.sadc.int/english/sarn/about-sarn/

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.

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.

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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