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. 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. 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.
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According to , a total of 55 RMs were granted market access (MA) and the number of first approval for regenerative medicine worldwide was highest in the United States, followed by Korea, EU, Japan, and India (). As of 2019, 16 RMs were approved in Korea, thus an accelerated approval program was needed for rapid market access. In other countries, whereas European Union (EU) and Japan enacted specific legislation for RM, the United States comprehensive act contains affecting cell therapy. In accordance with the these act, RMs got accelerated regulatory programs as follows: Regenerative Medicine Advanced Therapy (RMAT) designations in the US by the Food and Drug Administration (FDA), Priority medicine (PRIME) designation by the European Medicines Agency (EMA), and SAKIGAKE (fore-runner initiative) designation by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. In addition to the accelerated approval program, the need for financial support was raised to promote research and development. Therefore, Korea has implemented an Act on the safety of and support for ARMAB, which has differences from other countries.
Copyright © 2022 Kim and Bae.
- South Korea
- biological products
- regenerative medicine