DDReg Pharma- Consulting in regulatory affairs and drug safety

  On 27 November 2025, European Commission formally declared that four core modules of EUDAMED —  Actor Registration ,  UDI/Device Registration ,  Notified Bodies & Certificates , and  Market Surveillance  have met their functional specifications. As a result, a six‑month transition period begins, making these modules  mandatory  from  28 May 2026 . Why This Is a Big Deal End to “voluntary use” era : Until now, many companies used EUDAMED voluntarily or relied on national registries. From May 2026 onward, all responsible economic operators (manufacturers, authorised representatives, importers, Notified Bodies) must register and use these modules under MDR 2017/745 (and where applicable, IVDR 2017/746). Broader traceability and transparency : EUDAMED becomes the centralised system for device registration, UDI assignment, certificates, and market‑surveillance oversight. This strengthens regulatory oversight and harmonises device data across...

  Process Validation in pharmaceuticals is a core requirement for ensuring consistent product quality. Modern regulatory thinking, new manufacturing technologies, and updated global guidelines have reshaped how organisations design, qualify, and monitor their processes. This 2026-ready guide covers the current expectations, lifecycle stages, validation approaches, and the tools now used across the industry. What Process Validation Means in Pharma 2026 Process validation confirms that a pharmaceutical manufacturing process operates within established limits and reliably produces products that meet predefined quality attributes. It strengthens scientific understanding, supports  regulatory compliance , and integrates data-driven monitoring across the process lifecycle. Read more here:  Process Validation in Pharmaceutical Industry 2026

  Post-Brexit regulatory changes transformed the United Kingdom into an independent pharmacovigilance ecosystem. The shift created separate legal obligations, standalone reporting systems, and UK-specific safety governance.  Marketing Authorisation Holders  (MAHs) now manage two different regulatory pathways, i.e, EU/EEA and UK, as distinct jurisdictions. The UK framework remains science-aligned with the EU model, yet the processes, reporting tools, and legal requirements follow MHRA-defined rules. This guide sets out the complete picture so that MAHs understand every requirement needed for compliance. Read here:  https://resource.ddregpharma.com/blogs/post-brexit-pharmacovigilance-in-uk/

  Regulatory Affairs is undergoing a profound shift. For decades, it has been seen primarily as a function of process discipline, documentation, and compliance. Today, it stands at the crossroads of technology and strategy, redefining how therapies reach patients across global markets.  The digital transformation of  Regulatory Affairs  is not about replacing human expertise with systems. It is about  augmenting expertise with intelligence, foresight, and scale.  It is about equipping regulatory leaders with tools that transform compliance into a driver of innovation and market acceleration.  At DDReg , we have witnessed first-hand how organizations that embrace digital ecosystems in  regulatory operations  unlock unprecedented value, not only in efficiency but also in strategic influence within the boardroom. 

  Japan is the world’s third-largest pharmaceutical market, projected to reach USD 101.9B by 2033. But tapping into this opportunity means navigating one of the most complex regulatory landscapes in the world. From the PMDA’s rigorous scientific reviews to MHLW’s final approvals, understanding Japan’s regulatory framework is crucial. Key considerations include: Japan’s market rewards thorough preparation, local insight, and regulatory expertise. Looking to expand in Japan? DDReg helps you navigate every step from regulatory strategy to approvals and post-market compliance ensuring your product reaches Japanese patients efficiently and compliantly. Read more: Expanding to Japan’s Pharma Market? Here’s What You Need to Know - DDReg pharma

  Mechanistic toxicology represents a scientific evolution in safety evaluation. Instead of only identifying  what   toxic effects occur, it explains  how  they occur at a biological and molecular level. It focuses on identifying the mechanistic pathways that connect an exposure event to an adverse health outcome . This shift from observation-based toxicology to mechanism-based evaluation is redefining how regulators, pharmaceutical developers, and chemical safety professionals assess human and environmental risk. Mechanistic toxicology has become a cornerstone of Next-Generation Risk Assessment (NGRA), a modern approach emphasizing human-relevant, predictive, and non-animal methods supported by computational and systems biology tools. Why Mechanistic Toxicology Matters in Modern Safety Science Regulatory frameworks worldwide now expect safety assessments that demonstrate causal understanding. Mechanistic evidence provides regulators with clarity on biologi...