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Italy has long been a leader in pharmaceutical safety, with its unique systems for verifying and tracking medicinal products. However, with the full rollout of the European Union’s Falsified Medicines Directive (EU-FMD) and new documentation requirements, the pharmaceutical landscape in Italy is about to undergo significant changes. These updates, set Read more…
Indonesia has been steadily advancing its pharmaceutical serialization regulations since 2017, aiming to enhance the safety, traceability, and competitiveness of its pharmaceutical and food industries. The implementation of these regulations is being carried out in phases, with key milestones set for 2023, 2025, and 2027. Regulatory Framework: BPOM’s Role and Read more…
Serialization regulations are crucial for combating counterfeit drugs, thereby safeguarding lives. After all, the fundamental aim of pharmaceutical products is to protect and improve human health. In this article, we’ll break down what serialization means, how it applies to the pharmaceutical industry, and how you can leverage it for your Read more…
Azerbaijan’s Track & Trace System Set to Launch in 2024 The Republic of Azerbaijan is poised to revolutionize its pharmaceutical industry with the upcoming launch of its national track and trace system, DVTIS (Drug Persecution and Tracking System), expected to go live in 2024. This initiative aims to significantly enhance Read more…
Steps of Serialization and Traceability in the Pharmaceutical Industry The pharmaceutical industry faces numerous challenges, including regulatory scrutiny, patent cliffs, and complex supply chains. Drugs pass through various stages, from manufacturers to repackagers, dispensaries, and finally, patients. This extensive chain provides opportunities for counterfeit drugs to enter the market and Read more…
The UAE Ministry of Health and Prevention (MOHAP) has launched extensive regulations to ensure the traceability of pharmaceutical products, aimed at enhancing safety and authenticity throughout the supply chain. This initiative is centered on the Tatmeen track-and-trace system. Regulatory Framework On June 14, 2021, MOHAP issued Legislative Decree No. (73) Read more…
Introduction to Saudi Food and Drug Authority (SFDA) and Serialization Landscape The pharmaceutical sector in the Gulf Cooperation Council (GCC) countries has been undergoing transformation for over two decades, with serialization emerging as a pivotal challenge in recent years. As global pharmaceutical supply chains become increasingly intricate, the Saudi Food Read more…
Introduction: To safeguard the pharmaceutical supply chain from falsified medicines, EMVO hasimplemented robust alerting functionality, utilizing the FMD framework which was initially put intoplace on 9th February 2019. Challenges and Commitment: Initially, rapid system implementation led to a high volume of alerts.Timely analysis is crucial, and addressing every alert is Read more…
What sets Serialization apart from Track & Trace? In the realm of pharmaceutical logistics, the terms Serialization and Track & Trace often dance in tandem, presenting a unified front against the infiltration of counterfeit drugs into the hands of patients. However, beneath the surface, these seemingly synonymous terms reveal nuanced Read more…
Why talk about Master Data? In the complex realm of serialization within the pharmaceutical industry, the success of a product’s serialization hinges significantly on the accuracy and verifiability of information. Serialization data, often referred to as master data, encompasses vital details about the product, its source, and its intended destination. Read more…