Abstract: Background and Objectives: Regenerative medicine, as an emerging field at the intersection of life sciences, engineering, and advanced technologies, has a significant potential to change the health system paradigm from temporary to sustainable treatments. Despite the formation of scientific and technological structures in Iran, the lack of a comprehensive policy and regulatory framework, weakness in the safety and effectiveness assessment system, and sustainable financing mechanisms are the most important challenges for the development of this field in the country's health system. This study aimed to identify the main challenges for the development of regenerative medicine in the Iranian health system and to provide solutions for creating a safe, effective, and sustainable path in the application of these technologies. Methods: In this policy-based review study, scientific articles, policy reports, and authoritative documents published in the field of regenerative medicine were searched, reviewed, and summarized, focusing on regulatory frameworks, safety and effectiveness assessment, and financing models. Results: Evidence suggests that adopting a phased and integrated policy package based on governance and regulation by forming a national committee, reviewing regulations and designing risk-based frameworks, making decisions based on real evidence through the establishment of a national registry, and developing research and clinical structures, in addition to ensuring safety and public trust, provides a balance between supporting innovation and managing clinical and financial risks, and can pave the way for moving from emerging technologies to treatments available to patients. Conclusion: The successful development of regenerative medicine in the Iranian health system requires aligning scientific progress with policy reforms, a smart regulatory system, and new financing models. Without these reforms, existing capacities will not lead to sustainable clinical outcomes.