MEA Traceability

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

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.

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.

Iran

Iran has established a sophisticated pharmaceutical regulatory system designed to ensure the safety, efficacy, and quality of medicinal products throughout the country. The Iranian Food and Drug Administration (IFDA), operating under the Ministry of Health and Medical Education, serves as the primary regulatory authority overseeing all aspects of pharmaceutical oversight. This comprehensive framework reflects Iran's commitment to maintaining stringent standards that protect public health while facilitating access to essential medicines.

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.

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/

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