Jaseng Oriental Medicine Hospital's Pharmacopoeia Outpatient Bathroom Passes GMP due diligence, the only oriental medical institution
Sep 29, 2025
The Jaseng MediBio Center's Pharmacopoeia (hereinafter referred to as the Center Pharmacopoeia Room) recently passed the due diligence of the Ministry of Food and Drug Safety as the only oriental medical institution's outdoor bath room.
This is a due diligence conducted in accordance with the increased evaluation criteria since Korea joined the International PIC/S, and it is said that it has raised the overall level of the Korean medicine community in that the evaluation and due diligence of the most difficult of the GMP standards 'asmeptic injection level' was conducted.
Jaseng Oriental Medicine Hospital (Director Lee Jin-ho) announced on the 29th that the due diligence was carried out as part of the approval process for the Investigative New Drug (IND).
Earlier, Jaseng Oriental Medicine Hospital submitted an application to the Ministry of Food and Drug Safety to approve the clinical trial plan for 紫 車 (placenta extract) herbal medicine as part of the Ministry of Health and Welfare's oriental medicine innovation technology development project. Since then, the Ministry of Food and Drug Safety has started due diligence in the center's outdoor bath room to evaluate whether the clinical trial drug conforms to GMP. Good Manufacturing Practice (GMP) is an international standard that ensures that medicines are produced with stable and consistent quality.
The center's outdoor bath room met all the screening items in this due diligence. In particular, △ state-of-the-art automation facilities △ tablets exclusively for medicinal acupuncture?Sterile water manufacturing system △ thorough hygiene and process management △ safety and quality management system, etc. have received excellent evaluations that exceed the existing outdoor bathhouse certification standards in all manufacturing processes.
In fact, the center's medicinal needle outdoor bath room prepares high-quality medicinal acupuncture by removing microorganisms through cleanliness tests and nitrogen gas sterilization filtration systems, and preventing cross-contamination by dividing the four major lines (mandong line, raw material line, material line, waste line). Currently, herbal acupuncture at self-sustaining oriental medicine hospitals is prescribed at 5,000 oriental medicine hospitals and oriental clinics nationwide in recognition of this quality.
Thanks to this achievement, Jaseng Oriental Medicine Hospital was approved by the Ministry of Food and Drug Safety for a clinical trial plan for the study of the effectiveness and safety of self-substituted acupuncture for chronic low back pain. The research team at Jaseng Oriental Medicine Hospital plans to scientifically verify the effectiveness and safety of chronic low back pain treatment of Zaha's herbal acupuncture through multi-center clinical trials.
An official from Jaseng Oriental Medicine Hospital said, "This GMP due diligence and revitalization of herbal acupuncture research is an achievement that has systematically recognized the quality and safety of oriental medicine acupuncture beyond just meeting regulations." and added, "We will continue to contribute to the promotion of public health and the expansion of clinical research in oriental medicine through scientifically verified herbal acupuncture."
Meanwhile, the self-sustaining MediBio Center is the largest integrated oriental medicine preparation facility in Korea with a size of about 7,000 pyeong, and has obtained the 2nd cycle certification of the out-of-house room of the Ministry of Health and Welfare in the general herbal medicine and medicinal acupuncture sector.
This is a due diligence conducted in accordance with the increased evaluation criteria since Korea joined the International PIC/S, and it is said that it has raised the overall level of the Korean medicine community in that the evaluation and due diligence of the most difficult of the GMP standards 'asmeptic injection level' was conducted.
Jaseng Oriental Medicine Hospital (Director Lee Jin-ho) announced on the 29th that the due diligence was carried out as part of the approval process for the Investigative New Drug (IND).
Earlier, Jaseng Oriental Medicine Hospital submitted an application to the Ministry of Food and Drug Safety to approve the clinical trial plan for 紫 車 (placenta extract) herbal medicine as part of the Ministry of Health and Welfare's oriental medicine innovation technology development project. Since then, the Ministry of Food and Drug Safety has started due diligence in the center's outdoor bath room to evaluate whether the clinical trial drug conforms to GMP. Good Manufacturing Practice (GMP) is an international standard that ensures that medicines are produced with stable and consistent quality.
The center's outdoor bath room met all the screening items in this due diligence. In particular, △ state-of-the-art automation facilities △ tablets exclusively for medicinal acupuncture?Sterile water manufacturing system △ thorough hygiene and process management △ safety and quality management system, etc. have received excellent evaluations that exceed the existing outdoor bathhouse certification standards in all manufacturing processes.
In fact, the center's medicinal needle outdoor bath room prepares high-quality medicinal acupuncture by removing microorganisms through cleanliness tests and nitrogen gas sterilization filtration systems, and preventing cross-contamination by dividing the four major lines (mandong line, raw material line, material line, waste line). Currently, herbal acupuncture at self-sustaining oriental medicine hospitals is prescribed at 5,000 oriental medicine hospitals and oriental clinics nationwide in recognition of this quality.
Thanks to this achievement, Jaseng Oriental Medicine Hospital was approved by the Ministry of Food and Drug Safety for a clinical trial plan for the study of the effectiveness and safety of self-substituted acupuncture for chronic low back pain. The research team at Jaseng Oriental Medicine Hospital plans to scientifically verify the effectiveness and safety of chronic low back pain treatment of Zaha's herbal acupuncture through multi-center clinical trials.
An official from Jaseng Oriental Medicine Hospital said, "This GMP due diligence and revitalization of herbal acupuncture research is an achievement that has systematically recognized the quality and safety of oriental medicine acupuncture beyond just meeting regulations." and added, "We will continue to contribute to the promotion of public health and the expansion of clinical research in oriental medicine through scientifically verified herbal acupuncture."
Meanwhile, the self-sustaining MediBio Center is the largest integrated oriental medicine preparation facility in Korea with a size of about 7,000 pyeong, and has obtained the 2nd cycle certification of the out-of-house room of the Ministry of Health and Welfare in the general herbal medicine and medicinal acupuncture sector.
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This article was translated by Naver AI translator.
