Establishing the public infrastructure for Korean Medicine
Establishing the public infrastructure for Korean Medicine
We promote the Korean Medicine industry by building the public infrastructure to secure the scientific basis of Korean medicine.
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Korean Medicine Preclinical Center (GLP) Establishment Project
Purpose
- Enhancing the credibility of Korean Medicine through the evaluation of the Korean Medicine (or herb medicine) toxicity.
- Promoting the Korean Medicine industries through the support of product toxicity testing of herb medicine and botanical medicine for Korean Medicine.
Period
- Period : 2017.1 ~ 2019.12
Description
- Establishing a Korean Medicine Non-Clinical Study Facility (GLP).
- Address : 27, Kwondo Gwandeok-gil, Jangheung-eup, Jangheung-gun, Jeollanam-do, Republic of Korea
- Area: 8,000㎡ (Gross floor area 2,537m²)
- Testing the toxicity and safety of Korean Medicine ingredients and botanical materials, as well as herb medicine.
- General toxicity test (single and repeated administrations toxicity)
- Genetic toxicity test (back mutation, chromosomal aberration, or micronuclei, etc.)
Effects
- Evaluation of toxicity to enhance the public’s awareness and trust in herb medicine
- Promoting the Korean Medicine industry through the support of safety evaluations of herb medicine or Korean Medicine.
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Building a Korean Medicine product production facility (GMP) for clinical testing.
Purpose
- Promoting the industries for Korean Medicine through CMO of Korean Medicine and production/provision of Korean Medicine, placebo, or medicinal materials, etc.
Description
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Building a Korean Medicine product production facility (GMP).
- Address : 80, Cheombok-ro, Dong-gu, Daegu, Republic of Korea
- Area : 3,242 ㎡ (Gross floor area 3,164 ㎡)
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Developing and providing of Korean Medicine and placebos for clinical testing.
- Responding to the demand for the society of the safety and efficacy of Korean Medicine.
- Promoting the development of Korean Medicine by responding to the demands for the clinical testing of Korean Medicine.
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Developing and providing of the medicinal materials for Korean Medicine.
- Supplying medicinal materials for Korean Medicine of low frequency and high cost.
- Increasing the efficiency in production and standardizing quality by mass producing and supplying high quality medicinal materials.
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Contract manufacturing of Korean Medicine
- Supporting the manufacturers of Korean Medicine through CMO and the R&D efforts on the technologies for Korean Medicine.
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Establishing and operating a network of Korean Medicine pharmaceutical companies.
- Forming a network of mutual cooperation between pharmaceutical companies to invigorate the Korean Medicine industries.
Effects
- Securing the competitiveness of Korean Medicine by manufacturing and supplying Korean Medicine and placebos for clinical studies.
- Promoting Korean Medicine product industries by the CMO of Korean Medicine.
- Promoting continued growth of Korean Medicine industries through the formation and operation of a Korean Medicine network.
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EHD Certification and Herb Medicine Quality Control Program
Purpose
- Forming a system of hygiene and safety management Concoction facilities (internal/external) to ensure the safety and quality consistency of concocted herbal medicines (pharmacopuncture).
Business Outline
- Period: 2017.3 ~
- Description
- Providing the evaluation and certification services for EHDs.
- Running the training programs for evaluation committee members and the workers in EHDs.
- Monitoring the quality of concocted herb medicines and Korean Medicine ingredients.
- Setting the quality control indexes for concocted herb medicines or Korean Medicine ingredients.
- An EHD is a dispensary that is set up outside of a medical institution in accordance with Table 3 of the Enforcement Rules of the Medicine Act and is specialized in preparing concoction, pallets, powder, or other forms of herb medicines in accordance with the prescriptions by Korean Medicine doctors. Currently, there are 98 of such EHDs in Korea. (As of December 2017). The Certification Program for EHD will ensure the evaluation of the entire process of production in addition to the concoction facilities and their operations. The processes covered will range from admission to storage, preparation, packaging, and shipping, to make sure herb medicines are prepared safely.
Effects
- To encourage autonomous quality control through the operation of a safety control system for herb medicines (pharmacopuncture) that are prepared by EHDs.
- Enhancing the public’s opinion and trust in herb medicines in Korea.