DDReg Pharma- Consulting in regulatory affairs and drug safety

  Regulatory Affairs Services for Generics in Japan Japan’s  Ministry of Health, Labour & Welfare (MHLW)  and the  Pharmaceuticals and Medical Devices Agency (PMDA)  have taken a major step in harmonising generic drug regulation with  International Council for Harmonisation (ICH)  quality expectations. This shift extends key ICH guidelines including stability (e.g., ICH Q1 series) and impurity standards to generic pharmaceutical submissions in Japan. Why this matters:  Generic drug dossiers now must include  ICH-aligned quality data , including long-term stability studies tailored to Japan’s climatic conditions.  Applicants must use the  ICH CTD structure  (Modules 2 & 3) for consistency with global submissions.  Early  PMDA engagement  is key for clarifying expectations and avoiding review delays. Strategic impact for manufacturers:  Drives  regulatory convergence  with major markets (US, ...

  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/