A Major Compliance Shift: Algeria Makes Serialization Mandatory On October 12, 2025, Algeria’s Ministry of Pharmaceutical Industry introduced a decisive regulatory step forward. The Ministerial Decree No. 25 (Arrêté N°25 du 12 Octobre 2025), published in the Official Journal of the Algerian Republic, now makes serialization...
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Guinea-Bissau: Key Regulatory Deadlines and Requirements On 19 September 2025, the Government of Guinea-Bissau officially established its national pharmaceutical traceability system – the AVG Pharmaceutical Traceability Hub. The initiative was launched under Dispatch No. 31/GMSP/2025 and the Joint Dispatch of the General Health Inspection Office (IGAS) and...
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Cybersecurity Risks in Pharma: Why Identity and Cloud Security Are Now Compliance Priorities Cyberattacks against manufacturing companies are growing in scale and precision. According to the IBM X-Force Threat Intelligence Index 2025, manufacturing remains the most targeted industry worldwide for the fourth year in a row. Attackers...
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New SAHPRA Traceability Guideline Outlines Step-by-Step Implementation Roadmap The South African Health Products Regulatory Authority (SAHPRA) has published its official Traceability Guideline, defining a structured roadmap for introducing unique product identification and unit-level serialisation across all health products in South Africa. This marks a significant shift from...
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Africa’s Road to Pharma Traceability: Updates from 2025 Onwards Counterfeit medicines remain one of the biggest health threats in Africa. The World Health Organization (WHO) estimates that the continent accounts for 42% of all falsified medicines worldwide, and in some low- and middle-income countries, 10% of...
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Ukraine’s Potential Path to a National Medicines Verification System by 2028 Ukraine has taken a decisive step toward aligning its pharmaceutical supply chain with European Union standards. On 26 September 2024, the Cabinet of Ministers of Ukraine approved the creation of a national medicines verification system...
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Egypt Pharma Serialization: Track & Trace Timeline and Market Insights (2026) Last updated: August 2025, with the latest rollout dates announced by the Egyptian Drug Authority (EDA). Earlier this month, the Egyptian Drug Authority officially announced in the Official Gazette the launch of Egypt’s unified national electronic...
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Zimbabwe Serialization Update: What Pharma Companies Must Know On July 18th, Zimbabwe took an important step toward improving public health and combating counterfeit medicines by introducing new traceability guidelines for medical products. This targets pharmaceutical manufacturers, importers, exporters, distributors, and other relevant stakeholders. As a pharma company...
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Shift Happens: Pharma Serialization Flexibility Without Compliance Risk Shift happens. It’s the unspoken reality of pharmaceutical manufacturing. Let’s be honest. Shift isn’t the only thing that happens - machines stop, specs change, reports are delayed. And compliance? That still has a deadline. Pharma production plans are often built months...
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Paraguay Launches National Traceability System for Medicines and Medical Devices In April 2025, Paraguay took a significant step toward pharmaceutical supply chain modernization by launching the National System for the Traceability of Medicines and Medical Devices through Decree № 3668/25. This new regulation sets the foundation...
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Production Planning Is Predictable. Operations Are Not. Pharmaceutical manufacturing is one of the most planned environments in the world yet it’s also one of the most unpredictable. Machines go offline. A marketing campaign spikes demand. A partner changes specs mid-batch. Suddenly, the production plan you finalized weeks...
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New Traceability Rules in Ethiopia: What Pharma Exporters Must Do by 2026 The Ethiopian Food and Drug Authority (EFDA) is taking a major step forward in securing its pharmaceutical supply chain. With the launch of the EFDA-MVC Traceability Hub, Ethiopia is now enforcing traceability requirements for...
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Italy’s FMD Timeline at a Glance Italy’s transition to full EU Hub integration is well structured and full of deadlines. Here’s the timeline all MAHs should track: Until Feb 2027: Stabilization period; use of the “bollino” still allowed October 2025: Italy connects to the EU Hub...
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Snapshot: Greece’s Onboarding Progress Greece has made notable strides in FMD implementation. As of Q2 2025, the Hellenic Medicines Verification System (HMVS) has: 10,507 private pharmacies 135 public hospitals 148 wholesalers 91 private hospitals fully onboarded and scanning products. That’s 10,881 verified end-users integrated into the national...
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Why EU Hub Product Data Quality Matters Good data doesn't mean only a good structure. It is much more than it. It’s a compliance, a traceability, and trust. The EMVS relies on accurate Product Master Data (PMD) and Product Pack Data (PPD) to protect patients and...
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TeamFiltration: The Account Takeover Campaign Pharma Can’t Afford to Ignore Published: June 2025 | Author: SoftGroup Editorial Team A new cybersecurity campaign is targeting cloud-based business environments, specifically Microsoft 365 users. It’s called TeamFiltration, and its methods are simple but effective: brute-force attacks, credential stuffing, and highly...
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Algeria Advances Toward Pharmaceutical Traceability with New GS1 Guidance Published: June 2025 | Author: SoftGroup Editorial Team Algeria is entering a new phase in pharmaceutical regulation with the release of a draft circular and GS1 implementation guideline at the end of 2024. These documents outline the technical...
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New Pharmaceutical Labelling Rules Now in Effect in Sri Lanka: Key Details for MAHs and Importers Published: June 2025 | Author: SoftGroup Editorial Team Sri Lanka’s National Medicines Regulatory Authority (NMRA) has introduced new labelling requirements that affect all imported pharmaceutical products entering the country. The changes...
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DSCSA Enforcement Begins: A Global Signal for Supply Chain Transparency Published: June 2025 | Author: SoftGroup Editorial Team As of May 27, 2025, the U.S. Food and Drug Administration (FDA) has officially begun enforcing the Drug Supply Chain Security Act (DSCSA) for pharmaceutical manufacturers and repackagers. This...
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Pharmaceutical Cybersecurity at Risk: Lessons from Void Blizzard As the pharmaceutical industry continues to embrace digital transformation, the security of sensitive data and systems becomes not just an IT issue, but a compliance and operational priority. A new cyber threat, uncovered by Microsoft and known as...
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