The term "biological drug" which is subject to the approval and examination of items, such as biological agents, is a drug manufactured from human or other biological origin as raw materials or materials that requires special attention for health and hygiene, and defines it as including biological a...
The term "biological drug" which is subject to the approval and examination of items, such as biological agents, is a drug manufactured from human or other biological origin as raw materials or materials that requires special attention for health and hygiene, and defines it as including biological agents, gene recombination drugs, cell culture drugs, cell therapies, gene therapy drugs, and other drugs recognized by the head of the Ministry of Food and Drug Safety.
Among these biopharmaceutics, it is necessary to understand relevant regulations, statutes, licensing systems and evaluation items of major countries around the world in order to develop and apply cell therapies, especially stem cell therapies, to patients. This paper focuses on providing data that can help reform regulations related to advanced regenerative medicine by comparing and analyzing regulations, licensing systems and evaluation items related to stem cell therapy by major countries to examine the limitations and direction of change in stem cell therapy regulation considering the characteristics of stem cell therapy itself. To this end, the U.S., which leads the medical market based on Korea, and Japan's stem cell related regulations and decrees, which are the most deregulated in the field of stem cell therapies, were compared and analyzed, and Korea's laws, regulations, and guidelines related to advanced regenerative medicine. The statutes, regulations and guidelines of the United States and Japan were translated and used.
The term "biological drug" which is subject to the approval and examination of items, such as biological agents, is a drug manufactured from human or other biological origin as raw materials or materials that requires special attention for health and hygiene, and defines it as including biological agents, gene recombination drugs, cell culture drugs, cell therapies, gene therapy drugs, and other drugs recognized by the head of the Ministry of Food and Drug Safety.
Among these biopharmaceutics, it is necessary to understand relevant regulations, statutes, licensing systems and evaluation items of major countries around the world in order to develop and apply cell therapies, especially stem cell therapies, to patients. This paper focuses on providing data that can help reform regulations related to advanced regenerative medicine by comparing and analyzing regulations, licensing systems and evaluation items related to stem cell therapy by major countries to examine the limitations and direction of change in stem cell therapy regulation considering the characteristics of stem cell therapy itself. To this end, the U.S., which leads the medical market based on Korea, and Japan's stem cell related regulations and decrees, which are the most deregulated in the field of stem cell therapies, were compared and analyzed, and Korea's laws, regulations, and guidelines related to advanced regenerative medicine. The statutes, regulations and guidelines of the United States and Japan were translated and used.
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#biological drug, advanced regenerative medicine, statutes, regulations, guidelines
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