Are Your Products Compliant With SAHPRA’s Rules for Complementary Medicines?
Are Your Products Compliant With SAHPRA’s Rules for Complementary Medicines? Read More »
Regulatory Insight for QPPV and Deputy QPPV Appointments in Saudi Arabia
In the global pharmaceutical market, ensuring drug safety through proper pharmacovigilance practices is paramount. Regulatory agencies around the world mandate robust systems to monitor, assess, and report adverse drug reactions (ADRs) in a timely manner. In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) plays a crucial role in overseeing the safety of pharmaceutical
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COFEPRIS Cosmetics Registration Process: Guide for Global Brands Entering Mexico
As the Mexican cosmetics market continues to expand, attracting attention from global beauty brands, understanding local regulatory requirements becomes essential for successful market entry. Navigating the complexities of Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the country’s regulatory authority overseeing health and safety, is critical for ensuring that your products meet local
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Exploring the Future of Generative AI in Life Sciences
Generative Artificial Intelligence (Gen AI) has become a buzzword in the tech world, but its application goes far beyond creating content like text, images, and videos. While these creative applications are exciting, the real power of generative AI lies in its ability to generate entirely new data, models, and scientific insights transforming fields like life
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Taiwan Generic Drug Registration Process
As global pharmaceutical companies intensify their focus on Asia-Pacific markets, Taiwan has emerged as a key strategic hub offering a stable regulatory environment, robust IP protection, and a high generic drug uptake under a universal healthcare system. Despite its relatively modest population, Taiwan punches above its weight in terms of healthcare spending and quality standards.
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QPPV Deployment Across 11 Countries for PV Compliance
Customer Requirement A large US-based pharmaceutical company with a broad global footprint, multiple manufacturing sites, and an extensive pharmaceutical portfolio needed reliable local pharmacovigilance (PV) compliance support across 11 international markets covering over 30 marketed products. The brands under its portfolio had significant visibility and consumer demand, making any PV non-compliance a high regulatory and
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Global Pharmacovigilance Requirements for Devices and Combination Products
The traditional boundaries separating pharmaceuticals, biologics, and medical devices have blurred. With the rise of combination products, from drug-eluting stents and prefilled autoinjectors to inhalers with embedded sensors, the regulatory landscape has undergone a seismic shift. While pharmacovigilance (PV) for pharmaceuticals is well-established, the safety monitoring of PV for devices and combination products introduces distinct technical and
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Navigating SAHPRA: A Guide for Complementary and Traditional Health Products in South Africa
Complementary and traditional health products are now subject to increasing regulatory oversight in South Africa, driven by SAHPRA’s evolving mandate. Once considered outside the formal regulatory scope, CTMs are now under increasing scrutiny by the South African Health Products Regulatory Authority (SAHPRA). This shift signals the government’s intent to ensure that all health-related products regardless