DDReg Pharma- Consulting in regulatory affairs and drug safety

  The journey of a medicinal product continues long after approval. Once a drug reaches the real world, its true safety profile begins to emerge. Post-market pharmacovigilance (PV) ensures that every patient experience contributes to understanding the product’s benefits and risks in diverse, uncontrolled environments. This ongoing process is the foundation of public health protection. Traditionally,  Individual Case Safety Reports  (ICSRs) have served as the backbone of post-market safety surveillance. These reports, submitted by healthcare professionals, patients, and manufacturers, provide critical insights into adverse events (AEs). However, the landscape is evolving. With the growth of Artificial Intelligence (AI), Machine Learning (ML), and Natural Language Processing (NLP) technologies, the integration of  Real-World Data  (RWD) now complements and strengthens conventional reporting systems. RWD, sourced from electronic health records (EHRs), wearable devi...

  Artificial Intelligence (AI) is transforming Regulatory Affairs. While once limited to mobile apps and software, AI now powers  Regulatory Intelligence (RI) ,  helping businesses  monitor  global health and regulatory changes and make faster, informed decisions. Yet, the real-world application of AI often falls short of early hype. Some expect it to accelerate processes or simplify  workloads,  but the reality is more nuanced.     What is Regulatory Intelligence? Regulatory Intelligence is the process of evaluating and interpreting evolving regulatory data to support strategic decision-making and ensure continuous compliance. It is applied across sectors such as  pharmaceuticals ,  medical devices , and chemicals. RI helps organizations:     Adjust processes according to international guidelines (e.g.,  PMDA , FDA,  EMA ).   Evaluate impacts on products, markets, and operational workflows.   Guide sub...

Australia's Therapeutic Goods Administration (TGA) is rapidly transforming its drug registration landscape, positioning the country as one of the most agile environments for pharmaceutical market entry. The primary goal is clear: ensure faster patient access to life-saving therapies without compromising safety standards. Australia’s Evolving Drug Registration Pathways The TGA has introduced several key accelerated pathways to drastically cut down the standard 255-day review timeline. The Priority Review Pathway fast-tracks essential medications for unmet needs, targeting a review period of just 150 working days. For promising new drugs with early clinical data, the Provisional Approval Pathway grants short-term, time-limited registration, allowing early market access while requiring ongoing confirmatory data. These provisionally approved medicines are flagged with a distinctive black triangle (▼) for heightened post-market monitoring. A major driver of this speed is global alignm...