Combination Products: Global Regulatory Convergence and Complexity

📢 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 global harmonisation efforts by bodies like IMDRF and WHO with the persistent complexity arising from distinct regional frameworks in the US (FDA) and Europe (EMA/EU MDR).https://resource.ddregpharma.com/blogs/combination-products-in-2025-regulatory-convergence-or-compounding-complexity-2/