• 한국생물공학회:학술대회논문집
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• 2005.10a
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• pp.874-874
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• 2005

• 한국생물공학회:학술대회논문집
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• 2005.10a
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• pp.916-916
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• 2005

• 한국생물공학회:학술대회논문집
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• 2005.10a
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• pp.225-225
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• 2005

• 한국생물공학회:학술대회논문집
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• 2005.10a
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• pp.868-869
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• 2005

• 한국생물공학회:학술대회논문집
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• 2005.10a
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• pp.871-872
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• 2005

• The Journal of Korean Medicine
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• v.33 no.3
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• pp.147-159
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• 2012

Objectives: Systems related to the production, authorization, and listing for insurance of herbal medicine products were compared between South Korea and Taiwan to illuminate herbal medicine products system issues in South Korea. Methods: Papers, and laws and policies related to the production, authorization, and listing for insurance of herbal medicine products in South Korea and Taiwan are analyzed to create the primary documents. The documents from South Korea were screened with the advice of a specialist, while those from Taiwan have been verified through local investigation and with the help of a related specialist. The screened documents were then compared and analyzed in the order of the systems related to the production, authorization, and listing for insurance of herbal medicine products. Results: The systems related to the production of herbal medicine products satisfy GMP requirements in both countries, while Taiwan has more specialized systems related to the production of herbal medicine products and a more strict authorization program as compared to South Korea. While South Korea has most of the herbal medicine products classified as non-prescription drugs, Taiwan has them as prescription drugs. And while South Korea does not allow new herbal medicine products to be listed for insurance, Taiwan allows for once-a-year application toward listing for insurance. Conclusions: In order to ensure the safe and effective use of herbal medicine products, systems related to the production, authorization, and listing for insurance of herbal medicine products are to be established, while the categorization of medicine products principally used by Korean medicine doctors should be prepared. Furthermore, prescription by a Korean medicine doctor for new drugs made with natural products and their listing for insurance need to be encouraged.

• The Korean Society of Law and Medicine
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• v.8 no.1
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• pp.235-277
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• 2007

In Product Liability law, the 'defection' of the manufactured products is its key concept, defined in detail. The concept had been already developed through the precedents and theories for the past years even before the PL law was enacted and the concept was listed. Especially, the medicine products need the different approach, because they might directly harm to the human life and body due to their being injected or taken, unlikely other manufactured articles. Since the medical products have the double contradictory functions such as effects and side effects, the defection decisions become so difficult. However, because there are high concerns that wrong medical products will directly harm the human life and body, the decision standards should be more strengthened. The decision standards should include the risk-effect standard as the considered components and make the customer-expecting standard as the final standard. The decision time for defection should be made considering the science technology level when the medical products were provided, not when the accident occurred. It is the most important for the manufacturers to prevent the damages by making and selling the non-defective medicine products for themselves, rather than by taking the legal remedy means afterwards. Therefore, the non-defective guidelines for the medicine manufacturers will help increase the effects and minimize the side-effects.

• The Journal of Korean Medicine
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• v.21 no.2
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• pp.14-24
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• 2000

Objectives : To direct methods of management and development of herbs and their derived products, and at the end of this study to inform the process of making new herbal drug regulations in Korea. Methods : This study analyzed the regulations and laws of western medicine drugs. Results : We have got some herbal prescriptions which are not in the eleven books of oriental medicine now in use but which have proved effective. We need to establish standards for permissions to produce medical products through those prescriptions. Besides, we need the special permissions to produce herbal products through prescriptions, especially those which have been used to treat incurable diseases. And, we can contribute to globalization of oriental medicine and to well situating of herb products and medicinal acupunctures if we produce them according to international standards. It is thought that herbal medicine has no side effect in the medical society in Korea. But, it is getting popular to administer herbal medicine and western medicine together. Thus, the side effects of taking both medicines at the same time should be documented. Conclusions : Herbal medicines and herbal products should be under the control over the whole process of production, circulation, and sales. Now, it is time for herbal medicine to be known to all over the world. Therefore, herbal medicine must meet and adhere to the standards set by the western society and WHO.

• 한국생물공학회:학술대회논문집
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• 2005.10a
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• pp.910-910
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• 2005

• Journal of Society of Preventive Korean Medicine
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• v.12 no.3
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• pp.9-20
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• 2008

The purpose of this study is to investigate the actual conditions of herbal medicine products for the establishment of drug utilization review system. To accomplish of the purpose, we investigated medical treatment pay of insurance and consumption of herbal medicine products in pharmacy at jeollabuk-do, two oriental hospital etc. To gain valid and reliable the actual conditions of herbal medicine products, it needed close relationship with oriental hospital, society for manufacture of herbal medicines etc and further study classify herbal medicines by Korean Medicine.