Health Insurance Review and Assessment Service Researchers Describe Findings in Regenerative Medicine (Impact and challenges of enactment for advanced regenerative medicine in South Korea): Biomedical Engineering – Regenerative Medicine

2022 OCT 24 (NewsRx) -- By a News Reporter-Staff News Editor at Biotech News Daily -- A new study on regenerative medicine is now available. According to news originating from Wonju, South Korea, by NewsRx correspondents, research stated, “The Korean government has enacted the Act on Advanced Regenerative Medicine and Advanced Biological products (ARMAB) in August 2019, and it has been implemented in 2020.”

The news editors obtained a quote from the research from Health Insurance Review and Assessment Service: “We reviewed the changes made by ARMAB compared to the existing Pharmaceutical Affairs Act and discussed future challenges to accelerate regenerative medicine while ensuring safety and efficacy. This act and regulations focused on the key elements of act as follows: the definition of advanced regenerative medicine (RM), the licensing of related facilities, safety management such as long-term follow-up, clinical research review committee, and establishment of a roadmap. Our study shows that Korea has achieved the second highest number of first approvals for regenerative medicine indications worldwide through expedited approvals encouraging innovation, while maintaining patient safety by mandating long-term follow-up.”

According to the news editors, the research concluded: “Additionally, the establishment of an interactive system for retrieval of patients’ data and reporting of safety information by manufacturers electronically demonstrates Korea’s commitment to innovation for Advanced RM and patient safety.”

For more information on this research see: Impact and challenges of enactment for advanced regenerative medicine in South Korea. Frontiers in Bioengineering and Biotechnology, 2022,10. (Frontiers in Bioengineering and Biotechnology - http://www.frontiersin.org/bioengineering_and_biotechnology). The publisher for Frontiers in Bioengineering and Biotechnology is Frontiers Media S.A.

A free version of this journal article is available at https://doi.org/10.3389/fbioe.2022.972865.

Our news journalists report that additional information may be obtained by contacting Dong-Sook Kim, Department of Research, Health Insurance Review and Assessment Service, Wonju, South Korea. Additional authors for this research include SeungJin Bae. Our reports deliver fact-based news of research and discoveries from around the world.