Serialization is not one-size-fits-all. With varying mandates across the U.S., EU, Asia, and the Middle East, companies must navigate a complex web of requirements. Are you prepared for global compliance?
Navigating the Regulatory Landscape: Central Hub for Middle East Asia's Regulations and Related Links
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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.
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.
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.
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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