Additional Clinical Trial Plan for Pharmaceuticals Also Approved
Jaseng Korean Medicine Hospital announced on September 29 that the Acupuncture Herbal Medicine Preparation Room at Jaseng Medibio Center has become the only herbal medicine institution's external preparation facility to pass the Ministry of Food and Drug Safety's inspection for 'Good Manufacturing Practice (GMP)' standards.
An employee at Jaseng Medibio Center's Acupuncture Herbal Medicine Preparation Room is inspecting the production process of acupuncture herbal medicine. Jaseng Korean Medicine Hospital
This inspection was conducted as part of the approval process for an Investigational New Drug (IND) clinical trial plan. Previously, Jaseng Korean Medicine Hospital had submitted an application to the Ministry of Food and Drug Safety for approval of a clinical trial plan for Jaha-geoh (placenta extract) acupuncture, as part of the Ministry of Health and Welfare's Korean Medicine Innovative Technology Development Project. Subsequently, the Ministry of Food and Drug Safety conducted an inspection of the center's Acupuncture Herbal Medicine Preparation Room to assess its compliance with GMP standards for clinical trial drugs. GMP is an international standard that ensures medicines are produced with stable and consistent quality.
The Acupuncture Herbal Medicine Preparation Room met all evaluation criteria during this inspection. In particular, it received outstanding evaluations for its state-of-the-art automated equipment, a dedicated purification and sterilized water production system for acupuncture, thorough hygiene and process management, and a robust safety and quality control system, exceeding the existing certification standards for external preparation facilities.
The Acupuncture Herbal Medicine Preparation Room prepares high-quality acupuncture injections by conducting cleanliness tests, using a nitrogen gas sterilization filtration system to remove microorganisms, and preventing cross-contamination by separating the four main workflows (personnel, raw materials, supplies, and waste).
Building on this achievement, Jaseng Korean Medicine Hospital has also received approval from the Ministry of Food and Drug Safety for a clinical trial plan to evaluate the efficacy and safety of Jaha-geoh acupuncture for chronic low back pain.
A representative from Jaseng Korean Medicine Hospital stated, "This successful GMP inspection and the activation of acupuncture research not only fulfill regulatory requirements but also institutionalize the quality and safety of herbal acupuncture. We will continue to contribute to public health promotion and the expansion of clinical research in Korean medicine through scientifically validated acupuncture."
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