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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Why Serialization Compliance Is Critical for New CMOs Starting your journey as a Contract Manufacturing Organization (CMO) in the pharmaceutical industry requires more than production capabilities. Whether you’re operating in the European Union only or expanding into international markets like the United Arab Emirates, your ability...
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SATT PLATFORM: Compliance and Serialization Software for Pharma In today’s pharmaceutical industry, compliance is non-negotiable, but that doesn’t mean it should slow you down. Managing serialized production, responding to evolving regulations, and scaling across global operations requires a platform that understands both the regulatory and operational...
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Pharmaceutical Serialization in Pakistan: What You Need to Know Ahead of the 2025 Deadline As the pharmaceutical industry in Pakistan prepares for the full implementation of serialization regulations, August 2025 marks a significant compliance milestone. The Drug Regulatory Authority of Pakistan (DRAP) has set a clear...
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ResolverRAT: What Pharma Leaders Need to Know About This Advanced Threat A new malware threat is quietly targeting healthcare and pharmaceutical companies — and it’s engineered to bypass traditional security measures entirely. ResolverRAT, first identified in March 2025, uses advanced in-memory execution, regionalized phishing emails, and encryption...
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SATT PLATFORM®: The Future of Compliance and Efficiency in Pharmaceutical Manufacturing Pharmaceutical production is a delicate balance between efficiency, regulatory compliance, and operational flexibility. Traditional systems often impose rigid structures, limiting manufacturers' ability to adapt to market shifts, production demands, or last-minute regulatory requirements. This is where...
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Mandatory Digital Labelling of Medical Devices in Uzbekistan: What You Need to Know Uzbekistan's pharmaceutical and medical device industries are undergoing significant regulatory changes with the introduction of mandatory digital labelling. Starting February 1, 2025, medical devices will require digital serialization to enhance traceability, combat counterfeiting,...
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Italy’s Serialization Update: Key Requirements and What It Means for Pharma Companies Italy has significantly strengthened pharmaceutical compliance with the first implementing decree under the Falsified Medicines Directive (FMD). The decree mandates using a 2D Data Matrix barcode on secondary packaging, aligning with EU serialization standards. This...
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Beyond Barcodes: How Serialization Powers Compliance & Supply Chain Security Serialization in pharmaceuticals is often reduced to a simple concept - applying barcodes to product packaging. But in reality, it is a sophisticated framework that ensures regulatory compliance, secures global supply chains, and provides pharmaceutical companies...
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Serialization Compliance Mistakes That Can Cost Millions Pharma companies that fail to comply with serialization regulations risk millions in fines, product recalls, and reputational damage. Yet, despite its importance, many companies still make avoidable mistakes that put their operations at risk. In this article, we’ll explore the...
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Armenia Delays Mandatory Serialization for Medicines with Crypto Codes Until 2026 - What This Means for Pharma Companies The pharmaceutical industry in Armenia has been granted additional time to comply with mandatory serialization requirements. According to Government Decision No. 125-N, issued on February 6, 2025, the...
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Bahrain’s NHRA-MVC System Upgrade: What It Means for Pharmaceutical Compliance Bahrain's National Health Regulatory Authority (NHRA) has officially launched its upgraded NHRA-MVC system, marking a crucial step in ensuring compliance with Legislative Decree No. 41 (2017) for pharmaceutical track-and-trace. This upgrade strengthens Bahrain’s commitment to secure,...
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