• Title/Summary/Keyword: Product Verification Process

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"The U.S. military uses ginseng?": The official entrance of ginseng to the U.S. dietary supplement market and the U. S. military's dietary supplement manual in the late 20th century ("미군의 인삼 복용?" : 20세기 말 인삼의 미국 식이보충제 시장 편입과 미군 매뉴얼)

  • Seok, Yeong-dal
    • Journal of Ginseng Culture
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    • v.1
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    • pp.93-109
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    • 2019
  • This study aims to look at the process of ginseng being removed from the Western pharmacopoeia in the 19th century, experiencing a crisis as an export product in the America in the 20th century, and eventually settling in the U.S. society and the military as a dietary supplement in the 21th century. In this process, the legislation of provided a bridgehead for ginseng and other botanical dietary supplements to enter the U.S. market. As a result, ginseng could be re-listed in the U.S. pharmacopoeia as a dietary supplement. However, this did not mean a complete soft landing of ginseng and other botanical dietary supplements in the America. The U.S. medical community, which has been afraid of the indiscriminate spread of botanical dietary supplements, has constantly raised "the risk-discourse" and expressed concerns over the use and abuse of botanical dietary supplements that have not been scientifically verified. This involved not only the fundamental problems caused by the lax verification process of , but also a new atmosphere in the U.S. where the public sought information about botanical dietary supplements rather than seeking professional clinicians related to their health. Against this situation, "the advocate-discourse" suggested by dietary supplement manufacturers and the people in charge of botanical products seemed rather relaxed. As consumers are taking this side, the advocates had only to stress that botanical dietary supplements have been used worldwide for a long time without any problems and were made from 'natural' materials. The fact that ginseng and other botanical dietary supplements were able to advance to the U.S. Military's dietary supplement manual, which is strict in controlling food, seems to have jumped on the bandwagon of this atmosphere in the U.S. Society. In the early U.S. dietary supplement manual reviewed in this paper, ginseng was the most detailed among many botanical dietary supplements. Although there are some 'safety concerns' that still exist in the civilian society, but there are also certainly good scientific explanations for the efficacy and references to the popularity and influence of ginseng in the American society. Given this, the U.S. society and military's interest in ginseng as a dietary supplement seem quite high.

The Spatial Linkage and Complex Location of Kumi Industrial Complex -The Case of No.1 Industrial Complex- (구미공업단지의 공장입지와 연계 -제1단지의 경우-)

  • Cho, Sung-Ho;Choi, Kum-Hae
    • Journal of the Korean association of regional geographers
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    • v.3 no.1
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    • pp.183-198
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    • 1997
  • This case study was conducted by verification the site characteristics based on the questionnaire and interview obtained from the all factories located at No. 1 developing area in Kumi industrial complex. The site characteristics were presumed from the process of location behavior and spatial linkage. Kumi industrial complex was developed to improve export industry at national levels by providing chief land price and benefiting various tax. Kumi industrial complex which enticed many factories is playing an important role in export industry in Korea. At beginning, the detention of large enterprises promoted the establishment of related small to medium sized factories into the complex. Two distinctive industries. textile and electronic, were reflected by the purpose to establish the complex and industrial characteristics of Taegu city. respectively. In Kumi industrial complex, positive responses on traffic and raw material supply and negative reactions on the environmental impact on social community as well as high labor charge were investigated. Especially the higher labor cost prevented to hire laborers effectively. In the linkages of spatial and raw material, most factories in the complex depended on the availability of out side the Kumi city. For the textile factories, the supply of raw material and parts were relied on Taegu and/or other cities, whereas in electronic factories purchased them mainly from other cities and partly from abroad. Although questionnaire and interview suggested it, most of the parts were supplied by a parts maturing companies on the complex to a few large enterprises. In the marketing linkage, textile factories revealed higher relation-ship with the foreign countries and sewing factories in Korea. On the other hand, electronic factories have strong relation-ships in the marketing linkage to the parts supplying companies in the complex or large-scale resembling companies in other cities. In the textile companies, the right for decision on purchasing raw materials and parts is belonging to the owner whereas mother enterprise usually have the right for the marketing. In the case of the electronic factories, all the purchasing activities are related to the sub-contracting companies. In the service linkage, the Quality of the service created spatial distinction. There was high linkages on inside of Kumi complex for the low grade services such as repairing and installing machines, whereas strong linkages on outside of the complex for the high grade services such as management, law, taxation, new product development. and manufacturing technology. In the linkages of activity on the R&D (research and development), electronic factories do not have sufficiently qualified institutes in the complex. Strong regional linkages in the field of textile and electronic industries revealed limitations of the local industrial complex. In the sub-contracting linkage, high linkage ship within Kumi boundary reflected the characteristics of industrial site in the complex. There, most decisions by the companies centered by the mother enterprise.

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Critical Essay on the Notice of the Price Adjustment of Generic Drugs (제네릭 의약품 약가 조정 고시에 대한 비판적 고찰)

  • Park, Jeong Yeon
    • The Korean Society of Law and Medicine
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    • v.22 no.1
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    • pp.91-124
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    • 2021
  • In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.