DDReg Pharma- Consulting in regulatory affairs and drug safety

  Register Digital Health Apps in Germany Germany has taken a bold step toward digital transformation in healthcare. The introduction of the “DiGA Fast-Track” by the Federal Institute for Drugs and Medical Devices ( BfArM ) enables digital health applications to achieve rapid approval and reimbursement. This framework allows patients to access certified digital therapies prescribed by healthcare professionals under the statutory health insurance system. This blog provides a complete guide to understanding what DiGAs are, how the BfArM fast-track process works, and how developers and manufacturers can align with regulatory and clinical requirements to secure listing in Germany’s official DiGA Directory. What Is a DiGA? DiGA  stands for  Digitale Gesundheitsanwendungen , or  Digital Health Applications . These are medical device software solutions designed to support patient care, disease management, or treatment monitoring through digital technology.  A DiGA must...

  What Are Combination Products and Why They Matter in 2025 Combination products, where a  medical device , drug, or biologic come together to deliver a single therapeutic effect, are redefining how modern medicine reaches patients. From insulin pens and drug-eluting stents to AI-enabled inhalers, these hybrids represent the next frontier in precision treatment and patient convenience. The global drug-device combination market was valued at USD 138.48 billion in 2023 and is projected to reach USD 251.9 billion by 2030, growing at a 9% CAGR. Nearly 30% of all medical product filings now involve some form of drug-device combination. These numbers reflect both scientific progress and regulatory complexity. Despite years of harmonization efforts, each region continues to regulate the combination of products through distinct frameworks, definitions, and review mechanisms. For global manufacturers, the real challenge is no longer scientific feasibility, but regulatory navigation. Re...

  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...

  mRNA Technology Beyond Vaccines Messenger RNA (mRNA) technology has evolved from a niche research concept to a transformative force in global healthcare. While the COVID-19 pandemic accelerated its visibility, the scope of mRNA extends far beyond vaccines. From oncology to rare genetic diseases, mRNA-based therapeutics are reshaping the way diseases are treated, driving both clinical innovation and regulatory recalibration. For  pharmaceutical companies , this rapid evolution creates a dual challenge: navigating complex approval frameworks while staying ahead in a highly competitive innovation race. Understanding the current regulatory landscape and how it is adapting to novel modalities like mRNA is critical for ensuring market readiness and long-term success. Current Status of mRNA Technology The success of COVID-19 vaccines from Moderna and Pfizer-BioNTech demonstrated the scalability and speed of mRNA deployment. A major milestone followed in May 2024, when the U.S. FDA ...