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. […]
Taiwan Generic Drug Registration Process Read More »
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
QPPV Deployment Across 11 Countries for PV Compliance Read More »
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
Global Pharmacovigilance Requirements for Devices and Combination Products Read More »
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
Post-market evidence generation is becoming a strategic priority for life sciences companies. After a drug or medical device gains regulatory approval, the focus quickly shifts to long-term access, pricing, and continued patient benefit. This shift requires new, real-world evidence to validate both product safety and health system value. At the intersection of pharmacovigilance (PV) and
Post-Market Evidence Generation: Bridging PV and HTA for Long-Term Access Read More »
The global biopharmaceutical industry is undergoing a transformative shift as advanced therapy medicinal products (ATMPs) including gene therapies, somatic cell therapies, and tissue-engineered products and complex biologics become central to innovation pipelines. According to a Report by ARM, as of Q2 2025, there are over 1,900 active CGT clinical trials, 2,070 developers, and $5.0 billion in
GMP Compliance in the Era of Advanced Therapies and Biologics Read More »
With safety reporting in the European Union (EU) entering a new era of digital integration and oversight, pharmacovigilance systems have become more connected, data-driven, and strategically central to regulatory compliance. What once revolved around manual case handling and isolated national databases has transformed into a highly interconnected pharmacovigilance network. This shift is not only redefining
Evolving Safety Reporting in the EU: Beyond EudraVigilance to EVDAS & SPOR Read More »
Informed consent is a critical part of ethical clinical research, designed to ensure participants fully understand the nature, risks, and benefits of a trial before enrolling. However, for years, traditional paper-based consent processes have fallen short. Dense language, static formatting, and lack of personalization have made it difficult for many participants to grasp what they
Revolutionizing Informed Consent: Are Multimedia and eConsent the New Norm? Read More »
Egypt is fast emerging as a strategic healthcare hub in the MENA region, with a growing market for medical devices. For manufacturers looking to access this market, understanding the regulatory framework laid down by the Egyptian Drug Authority (EDA) is critical. Unlike the traditional pharmaceutical landscape, medical device registration in Egypt is governed by its
How to Register a Medical Device in Egypt: Regulatory Pathways with the EDA Read More »
Regulatory submissions have always been the linchpin of drug development. From paper-based dossiers to the globally adopted electronic Common Technical Document (eCTD), the journey of regulatory documentation has continuously evolved. However, as life sciences companies contend with increasing data volumes, complex global regulatory requirements, and pressure to accelerate time-to-market, even eCTD processes are showing their
AI-Powered Regulatory Submissions: A New Era for IND, NDA, & BLA Documentation Read More »
