• Journal of Society of Preventive Korean Medicine
• /
• v.18 no.1
• /
• pp.23-41
• /
• 2014

Objective : The purpose of this study was to lay the groundwork for understanding the details and scope of the legal definition of medicinal products, following the changes in the relevant laws and regulations. This will let readers properly understand the origins of the ongoing conflicts on herbal drugs and new drugs from natural products that are present in the medical field and the medical industry. Possible solutions are proposed in the end. Method : I analyzed the changes in definition of medicinal products since 1945 that have been used in relevant laws and regulations(i.e. Pharmaceutical Affairs Act) and drug approval process(i.e. New Drug Application and Investigational New Drug Application). Results : Legal definition of medicinal products has changed in accordance with the changes in the pharmaceutical industry, such as the establishment of dualistic medical and pharmaceutical System and the introduction of the substance patent. Due to those changes, boundaries of Western medicinal products and health food expanded, while those of herbal medicine products relatively downscaled. Conclusion : Legal definition of medicinal products-i.e. Herbal Drugs, Crude Drugs, and New Drugs from Natural Products-should be reestablished according to academic legitimacy and dualistic medical and pharmaceutical System.

• The Journal of Korean Medicine
• /
• v.35 no.3
• /
• pp.135-154
• /
• 2014

Purpose: There is an issue in applying various principles introduced in established Korean medical classics to "Pharmaceuticals Approval, Notification and Review" of "herbal medicinal preparations" and "new drugs from natural products" that are used for western forms of medical treatment. Thus, an analysis of the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act is essential. Methods: We collected data regarding the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act, and classified them by periodical change and subjects. Results: Established Korean medical classics are applied as follows: 1) as criteria for Korean medicine distributors' sales of mixed herbal drugs (Pharmaceutical Affairs Act; since 1953), 2) as official compendiums for pharmacists' preparation of Korean medicine (Ministry of Health and Welfare's authoritative interpretation; from early 1970s to 1993), 3) as standards for oriental pharmacists' quality measurement of preparations (notification of the Ministry of Health and Welfare; since 1995), 4) as criteria for "Pharmaceuticals Approval, Notification and Review" of herbal medicinal preparations and crude drug preparations (notifications regarding drug approval process by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety; since 1978), and 5) as standards for the quality of materials of health functional food (from 2004 to 2011). Conclusion: The application of Korean medical classics has been closely related with the change of the laws, regulations, and systems that are relevant to Korean medicine, and it seems to be more favorable for pharmacists than oriental pharmacists. Meanwhile, regulations that apply prescriptions that are recorded in Korean medical classics - dosage, indications, and preparation methods - as criteria for the approval of crude drug preparations for western medical treatment should be abolished.

• The Korean Society of Law and Medicine
• /
• v.21 no.2
• /
• pp.3-33
• /
• 2020

Until recently the German and the South Korean medical associations reacted cautiously to the introduction of telemedicine between doctor and patient which is exclusively on the platform conducted. But the General Assembly of German Physicians voted to lift the ban on remote treatment with the amendment to Section 7 (4) MBO-Ä(Medical Association's Professional Code of Conduct) in 2018 and the situation has been fundamentally changed in Germany. From then until now 16 of 17 rural medical associations have changed their professional code to allow telemedicine. In addition the legislature started to prepare the basis for the introduction of the electronic health card (eGK) and the telematics infrastructure. So far, various laws such as Medicinal Products Act, Drug Advertisement Act and Social Code have been changed to support legalization of telemedicine and digitalization of health care. Unlike in Germany, the social circumstances such as excessive centralization of the big hospitals in Seoul and the resulting concern of small medical practices for profitability are the main obstacles to the introduction of telemedicine. However the German approach how to legalise the telemedicine and to prepare for legal and technical infrastructure is also interesting in South Korea. The discussions for and against the changes in the law and the telematics infrastructure attempted by the German government for several years indicate that not only lifting the ban on remote treatment, but also harmonization of all the related legal system could guarantee successful implementation of telemedicine.

• Journal of Ginseng Research
• /
• v.46 no.2
• /
• pp.188-205
• /
• 2022

Panax ginseng is a medicinal plant is a material with various pharmacological activities and research suggests that it is particularly effective in representative metabolic diseases such as hyperglycemia, hypertension, and hyperlipidemia. Therefore, in this study, systematic review and meta-analysis were performed to investigate the comprehensive effect of P. ginseng on metabolic parameters representing these metabolic diseases. A total of 23 papers were collected for inclusion in the study, from which 27 datasets were collected. The investigational products included P. ginseng and Korean Red ginseng. Across the included studies, the dose ranged from 200 mg to 8 g and the supplementation period lasted from four to 24 weeks. The study subjects varied from healthy adults to those with diabetes, hypertension, obesity, and/or hyperlipidemia. As a result of the analysis, the levels of glucose and insulin area under the curves, % body fat, systolic and diastolic blood pressures, total cholesterol, triglycerides, and low-density lipoprotein cholesterol were significantly reduced in the P. ginseng group as compared with in the placebo group. In conclusion, P. ginseng supplementation may act as an adjuvant to prevent the development of metabolic diseases by improving markers related to blood glucose, blood pressure, and blood lipids.

• Journal of the Korean Society of Food Science and Nutrition
• /
• v.24 no.6
• /
• pp.1026-1038
• /
• 1995

Although aloe lost a lot of its previous popularity in modern clinical uses as medicine numerous scientific researches still have claimed the beneficial properties(curing and general tonic effect) of aloe gel. Whereas considerable contradictory reports have helped to confuse the aloe gel issue and continually aroused controversy about aloe gel efficacy. However health food, cosmetic and medicinal products made from aloe gel are widely available in the world market especially in U.S.A. so the growing of Aloe plant and the processing of A. vera gel have become big industries in some countries. In some previous papers the salicylic acid, one of the common trace gel components, was thought to have an analgetic and antinflammatory effect. Large amount of Mg ion in the gel was suggested to act as anesthetic, Mg-lactate as antihistamic, and Aloctin A(a glycoprotein) as wound healer by promoting the cell growth. The carboxypeptidase and bradykinase activity in the gel were proposed to have the pain relieving and antiinflammatory effect. But any of thes etheories concerining the physiological action of the trace gel components has not been demonstrated by modern pharmacology, and failed to be supported by clinical research. It was suggested by some research workers that trace amount of anthraquinone compounds in the gel play an important role to act as false substrate inhibitors for PG and TX production(antiprostanoid effect), by which, they believed, inflammation, burn and frostbite, and infected wound could be healed. This hypothesis has not been substantiated. Butthe suggested antimicrobial action, antidiabetic, and antidotic effect of aloe gel are likely to be attributed to the trace anthraquinone compounds. In a lot of recent experimental reports it has been claimed that aloe gel polysaccharides(acetylglucomannan, acetylmannan, and glycoprotein) have the antimicrobial, antinflammatory, antitumour, and infected wound healing effect by immunoenhancement. It is hoped that these effects will be soon documented in clinical studies, then the controversy on aloe gel beneficial effect will cease. In the 30 days subchronic toxicity test the lowest observed adverse effect level of acemannan(acetylmannan) on dog was 5.0 mg/kg, IP. But the aloe gel is generally agreed to be harmless and non toxic even for the internal use such as health food. In the case of idiosynrasy one must keep the delayed type hypersensitivity reaction of aloe gel in mind. In conclusion it seem to be impossible to simply refuse a lot of evidences made by research workers who have claimed aloe gel's beneficial effects and to deny the fact that there had been long therapeutic histories of Aloe plants.

• Journal of the Korean Society of Food Science and Nutrition
• /
• v.34 no.3
• /
• pp.374-379
• /
• 2005

The intake of health foods with physiological effects may cause adverse effects due to their intrinsic compounds, external contamination or consumers' eating patterns. To keep pace with the increasing interest on the safety assurance, Health Functional Food Act has been enacted and standards and specifications for 32 products have been proclaimed by Korea Food and Drug Administration in 2004. To reduce the safety problems related with the intake of non regulated health intended food, we classified the health intended foods materials into two groups, as proclaimed health functional food materials and others, and examined the difference of intake patterns on both categories. Among 16,474 health intended foods responded by 5,175 respondents and their household members, 49.2% were categorized as health functional food materials. The average number of total health intended foods intake and health functional foods intake per person were 3.19 and 1.58 respectively. The proportion of health functional foods in total health intended foods per person was higher in the group with less than 20 years old, therefore this age group needs relatively low concern. On the other hand, 40-59 years old females who have taken the highest number of health food items, 30-59 years old males who had the lowest proportion of health functional foods to total health intended food, and their consumed foods such as medicinal plant and animal protein based restoratives need relatively high concern about intake safety of health foods.