DDReg Knowledge Capsule

📢 DDReg Knowledge Capsule – Episode [15]The regulatory landscape for combination products in 2025, defining them as items where drugs, devices, or biologics combine for a single therapeutic effect, such as insulin pens. It highlights the rapid growth of this market, which is projected to reach USD 251.9 billion by 2030, reflecting both innovation and regulatory challenges. The text contrasts the ...

📢 DDReg Knowledge Capsule – Episode [14]How Artificial Intelligence (AI) is fundamentally transforming the field of pharmacovigilance (PV), specifically in case management and signal detection. It explains that AI technologies, such as Natural Language Processing (NLP) and Machine Learning (ML), are moving drug safety surveillance from a slow, manual, and reactive process to a proactive and predi...

📢 DDReg Knowledge Capsule – Episode [13]This Podcast explains that because CGTs are transformative but complex, specialised pharmacovigilance (PV) is essential throughout the entire product lifecycle, from preclinical evaluation to long-term follow-up (LTFU), which can extend up to 15 years. The text outlines key components of PV, including risk assessment, clinical safety monitoring for events l...

📢 DDReg Knowledge Capsule – Episode [12]Discusses the application of  Artificial Intelligence (AI) in Regulatory Intelligence (RI), seeking to differentiate the genuine utility of the technology from industry hype. It defines RI as the process of evaluating regulatory data to support strategic decision-making and compliance, particularly within sectors like pharmaceuticals and medical devices. Th...

📢 DDReg Knowledge Capsule – Episode [11]while the COVID-19 pandemic accelerated mRNA visibility , its scope now includes cancer immunotherapies, treatments for genetic and metabolic disorders, and regenerative medicine, with the global market projected for significant growth. The text also outlines both the key benefits of mRNA, such as speed and versatility, and the inherent challenges, includin...

The United Arab Emirates is one of the Middle East's fastest-growing pharmaceutical markets, offering a strategic gateway for global manufacturers But entering this lucrative market requires navigating a complex regulatory landscape. In this episode, we unpack the essential guidelines for the drug product registration process in UAE . We explore the roles of the two key regulatory authorities: the...

📢 DDReg Knowledge Capsule – Episode [9]Overview of pharmacovigilance in New Zealand , highlighting the regulatory framework overseen by Medsafe under the Medicines Act 1981. It explains that the country participates in the WHO International Drug Monitoring Programme and uses systems like the Suspected Medicine Adverse Reaction Search (SMARS) database to gather post-market safety information. The...

📢 DDReg Knowledge Capsule – Episode [9] pharmacovigilance (PV) inspections preparedness , conducted globally by regulatory bodies to ensure compliance among marketing authorization holders. These inspections, which can be announced or unannounced, verify that systems, facilities, and processes adhere to PV requirements and aim to identify non-compliance that could potentially harm patients. The a...

📢 DDReg Knowledge Capsule – Episode [8]In-depth guide to the  drug registration process in Mexico , highlighting its importance as the second-largest pharmaceutical market in Latin America. The core of the process is overseen by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), which categorises medicines into distinct regulatory pathways, such as New Chemical Entities...

📢 DDReg Knowledge Capsule – Episode [8]In this podcast, we cover the steps and points that any global and local entity should follow when planning to register their new drug product in the Indian market .

📢 DDReg Knowledge Capsule – Episode [7] ⁠⁠⁠ In-depth analysis of the European Union’s Packaging and Packaging Waste Regulation (EU PPWR), officially designated as Regulation (EU) 2024/1781, which replaces a previous directive to mandate stricter sustainability standards across the EU. This new regulation, which entered into force in February 2025, aims to prevent waste, ensure all packaging is re...

📢 DDReg Knowledge Capsule – Episode [6] ⁠ Introduces the concept of  Translational Biology  and explains how this field is accelerating the development of new therapies by creating a continuous feedback loop between laboratory discovery and patient care. The article outlines the multi-stage Translational Biology Pipeline (T0 to T4), which moves findings from basic research through clinical trials...

📢 DDReg Knowledge Capsule – Episode [6] Strategic Pharmacovigilance Checklist for Biosimilar Safety in 2025 ," which offers guidance on managing the increasing complexities of biosimilar safety. The article explains that the biosimilar market is rapidly expanding, necessitating robust pharmacovigilance (PV) to ensure patient safety and mitigate risks. It presents a comprehensive checklist coverin...

📢 DDReg Knowledge Capsule – Episode [5]Overview of the drug approval process in the Chinese pharmaceutical market, highlighting its significance as the world's second-largest. It details the types of drugs approved, including innovative medicines, generics, and traditional Chinese medicines, and identifies the key regulatory bodies, namely the National Medical Products Administration (NMPA) and t...

📢 DDReg Knowledge Capsule – Episode [5]Low data doesn’t mean low risk. In this episode, we unpack how PV teams detect signals in low-volume markets, using smarter tools, sharper strategies, and local expertise to keep drug safety ahead of the curve. For mor Visit our blog https://resource.ddregpharma.com/blogs/signal-detection-in-low-volume-markets-how-smart-pv-teams-stay-ahead/

📢 DDReg Knowledge Capsule – Episode [4]This DDReg Knowledge Capsule focuses on  cybersecurity in connected medical devices , highlighting the critical balance between technological advancement and patient safety. It discusses the evolving landscape of cyber threats and the regulatory frameworks put in place by bodies like the FDA and the Department of Health and Human Services to address these ri...

📢 DDReg Knowledge Capsule – Episode [3]In this episode of the DDReg Knowledge Capsule,introduce  point-of-care diagnostics (POC)  as a rapidly expanding sector within the in-vitro diagnostics industry. It explains that POC devices facilitate quick medical testing near the patient, leading to faster diagnoses and improved outcomes, particularly in situations where resources are limited. 

📢 DDReg Knowledge Capsule – Episode [2]In this episode of the DDReg Knowledge Capsule, we dive into Digital Therapeutics (DTx), highlighting their role in transforming chronic disease management. It details how DTx, which are clinically validated, software-driven interventions, empower patients through personalised, data-driven care, evidence-based behaviour change, and 24/7 accessibility. 📍Stay...

📢 DDReg Knowledge Capsule – Episode [1]In this episode of the DDReg Knowledge Capsule, we dive into the evolving landscape of Software as a Medical Device (SaMD) — a transformative area in digital health that's reshaping patient care and healthcare delivery. Join us as we explore: 🔹 What qualifies as SaMD under global regulatory frameworks 🔹 Key regulatory guidelines from the FDA, EU MDR, and I...