Regulatory Frameworks and Clinical Development of Orthobiologics Across Asia and Europe.

Lee, Jin Kyu; Kon, Elizaveta; Anzillotti, Giuseppe; Nakamura, Norimasa · J Bone Joint Surg Am · 2026

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Abstract

Asia and Europe are rapidly expanding hubs for orthobiologics, driven by aging populations, advancing infrastructure, and growing evidence for regenerative therapies. Regulatory heterogeneity across both regions remains a major barrier, highlighting the need for international collaboration to support safe, responsible innovation.