• Title/Summary/Keyword: regulations on standard Korean

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A study on the Problems and Improvement Proposals on Legal Definitions in Respect of Herbal Medicinal Preparations, Crude Drug Preparations and New Drugs from Natural Products (한약제제, 생약제제와 천연물신약의 법규상 개념 및 정의의 문제점과 개선안)

  • Eom, Seok-Ki
    • Journal of Korean Medical classics
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    • v.27 no.4
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    • pp.181-198
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    • 2014
  • Objectives : This study was to analyze definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Regarding the current laws and regulations that are relevant to herbal medicinal preparations, we should 1) clarify the boundaries between the duty of physicians and that of pharmacists, 2) limit the principles of Korean Medicine as well as the contents of the related textbooks, 3) find a way to protect the intellectual property rights for herbal medicinal preparations, and 4) establish a separate standard for drug classification regarding herbal medicinal preparations. In case of crude drug preparations, we should 1) clarify the meaning and limitations of the phrase, "the point of view of Western medicine," and 2) establish a classification standard for drugs that are used in Korean Medicine and clarify the boundaries between herbal drug preparations and crude drug preparations. Furthermore, laws and regulations apropos of new drugs from natural products do not actually fit the concept of "new drug," and due to subordinate laws, a supplement to a new drug submission is contradictorily misclassified as a new drug from natural products. Conclusions : The problems of legal definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products have emerged in the process of giving approval to drugs that are made of herbs and natural products under the dualistic medical and pharmaceutical System. Laws and regulations that differentiate the process of approving herbs that are used in Korean Medicine and the others should be established.

A Consideration of Installation Method of Debris Net and Horizontal Safety Net (낙하물 방지망 및 추락 방호망의 설치방법에 관한 고찰)

  • JI, Suk-Won;Chol, Soo-Kyung
    • Proceedings of the Korean Institute of Building Construction Conference
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    • 2019.05a
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    • pp.131-132
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    • 2019
  • In the Public Notice No. 2019-15 of the Ministry of Employment and Labor, the safety net and regulations on them have been deleted. The performance criterion of the debris net, which also functions as a horizontal safety net in the regulations on the criteria of occupational safety and health, is unclear. When installing a debris net that also functions as a horizontal safety net, a net that meets the performance criteria of KS F 8082 must be installed in accordance with KOSHA C-31-2017. The Korean Standard Specification for Construction Works, which specifies debris net and horizontal safety net, should be revised as soon as possible.

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A Study on the International Standard and Regulation for Electric Motor and Drives (전동기와 드라이브의 국제 규격 및 규제에 관한 현황 연구)

  • Woo, Kyung-Il;Park, Han-Seok;Kim, Dea-Kyong;Choi, Han-Seok;Jun, Hee-Deuk
    • The Transactions of The Korean Institute of Electrical Engineers
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    • v.63 no.3
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    • pp.437-443
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    • 2014
  • Electric motors and drives consume the largest amount of electricity more than 40% of global electricity consumption. In addition, motors, drives and its components are included in the global high-trade products and the main driving source for industrial equipment and house appliances. Thus, International standards and regulations for their safety and efficiency are internationally being discussed and created for the protection of its citizens and energy saving. So, understanding the international standards and the regulation of each country is essential to enhance overseas market and to develop product. In this paper, on the basis of this background, status and trends of international standards and regulations are introduced for safety and efficiency of motors and the drives. Safety and efficiency of the IEC (International Electrotechical Commission) standards are introduced in the emphasis. Also, regulations are studied about the differences and trends in each county.

Technical Review of the IAEA Regulations for Transportation of Radioactive Materials and Major Revision in the 1996 IAEA Safety Standard Series No. ST-l (IAEA 방사성물질 안전운송규정에 대한 요약과 1996년도판 개정의 요점)

  • Yoon, Jeong-Hyoun;Kim, Chang-Lak;Cho, Gyu-Seong;Choi, Heui-Joo;Park, Joo-Wan
    • Journal of Radiation Protection and Research
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    • v.23 no.3
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    • pp.197-210
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    • 1998
  • Regulations for the safe transport of radioactive material published by IAEA Safety Standard Series ST-l is reviewed and summarized. Safety Series No.115(International standard of radiation protection and safety for ionizing radiation and radiation sources), which reflected the new recommendation of ICRP60 published in 1991, has been a important encouragement for IAEA to revise their safety series related to the transportation of radioactive materials. IAEA Safety, Standard Series No. ST-l is summarized by comparing IAEA Safety Series No.6 regarding radiation protection system and its implementation, technical standards of packages, concept of Q system and exemption of regulation. The IAEA regulations of transportation of radioactive materials is summarized from the viewpoint of radiation protection and safety assessment. Research on transportation system of radioactive waste is suggested as a further study.

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Supplementation of Regulation on the Offshore Oil Pipeline for Maintenance (해저 송유배관 유지관리를 위한 기준 보완 제시)

  • Kang, Chan-Seong;Moon, Seung-Jae
    • Plant Journal
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    • v.8 no.2
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    • pp.70-81
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    • 2012
  • The study aims to supplement facility management plan and safety regulations & standard of oil pipeline by searching and reviewing related regulation & standard inside and outside of the country. Korean regulation & standard is reviewed based on harbor and fishery design standard of the ministry of maritime affairs and fisheries, general technology standard of oil pipeline safety regulation, gas excavation construction and safety maintenance indicator of Korea gas corporation. Global regulation & standard is reviewed based on U.S standard inspection for offshore pipeline and Europe/Mexico standard inspection for offshore pipeline. The contents of offshore pipeline installation is inserted into pipeline sector for objected facilities of safety inspection regulation & standard and, the standard of safety inspection for offshore pipeline is newly presented into pipeline maintenance part of the planning facilities management with its inspection period and method.

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Estimating Spatial Scope of Local Government Ordinance for Onshore Wind Energy Generation Facilities (육상풍력 발전시설 지자체 규제 공간범위 산정 연구)

  • Sung Hee, Hong;So Ra, Kim;Eun Jung, Park;Hye Rim, Lee;Jin Young, Kim;Su Jin, Hwang;Jung Eun, Song
    • New & Renewable Energy
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    • v.18 no.4
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    • pp.38-53
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    • 2022
  • T Recently, the government has been promoting the expansion and supply of renewable energy as an alternative for achieving carbon neutrality and the nationally determined contributions by 2030. In 2020, the Ministries of Industry and Environment and the Korea Forest Service collaborated to build a nationwide onshore wind energy siting atlas considering wind resources and forestry and environmental regulations focused on central regulations. In this study, the ordinances of the local governments were analyzed to examine the effects of regional location regulations on the expansion of onshore wind power energy generation facilities, in addition to those of central regulations. A development permit standard survey of 226 urban plan ordinances of the local governments nationwide showed that presently in 2022, 52 municipalities are applying regulations on wind energy generation facilities by ordinances. This is twice more than that in 2018, when renewable energy power generation facility development was difficult. Additionally, the location regulations applied by these ordinances were organized by items and regions, and regulatory characteristics, such as the number and scope, were analyzed by regions. To analyze the spatial distribution characteristics, JeollaNamdo was selected as the case area. A spatial DB was established for regulated areas based on the regional and central regulations, and the spatial distribution characteristics and the regulatory scope were compared and analyzed.

A Study on the Maintenance System Improvement for Commercial Residential Buildings (주상복합건물의 유지관리 제도 개선방안)

  • Kim Seung-Jin;Baeck Kwang-Sub;Yeo Jong-Seok
    • Proceedings of the Korean Institute of Building Construction Conference
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    • 2005.05a
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    • pp.191-196
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    • 2005
  • Unpreparedness of the maintenance regulations is regarded as the main reason for the short life span of the multi-owned commercial residential buildings. This study suggests that the followings should be prepared for the effective maintenance and life prolongation of the multi-owned commercial residential buildings : 1) Standard maintenance regulations for those buildings should be set up, 2) Building maintenance works should be performed by the specialists, like licensed building manager, mechanical and electrical engineers, etc., 3) Long-range repair expenses should be laid by on the monthly base according to the long-range repair plan, 4) Regulations concerning the defect repair should be provided properly.

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Comparative Analysis of Regulations for Consumer Protection of Local Self-government (지방소비자행정 발전을 위한 광역자치단체의 소비자보호조례와 소비자정책심의위원회 운영 현황 비교분석)

  • 송인숙;제미경
    • Journal of the Korean Home Economics Association
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    • v.40 no.9
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    • pp.79-95
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    • 2002
  • In this paper the consumer protection regulations of 16 wide area self-governments in Korea are studied. Status of consumer protection policy committees and their general policies for consumer protection of these wide area self-governments are also investigated. The data of consumer protection regulation were collected from the internet web-site of each self-government and the status of consumer protection policy committee and the general policy for consumer protection were obtained by requesting each self-government to report administration information during May through October in 200l. 13 of 16 wide area self-governments except Daegu, Inchon, and Jejudo have own consumer protection regulations. Major parts of these regulations conform the standard regulation of ministry of Government Administration and Home Affairs. Many of the consumer protection policy committees reported that they do not have meetings constantly. Moreover since the price of goods and services is the typical subject of meetings, the committees do not seem to properly play the role of a consumer protection policy authority. Contents of the general policy for consumer protection of many self-governments are simple description of detailed practicing plans according to the general consumer protection policy of the national government. By criticizing the problems aroused during the study of consumer protection policy of self-governments, suggestions are given which will help for the development of consumer policy of wide area self-governments.

A Study on the Changes in Regulations Regarding Approval, Notification and Review of Herbal Medicinal Preparations and Crude Drug Preparations - From 1948 to 2012 - (한약・생약제제 품목허가신고심사 규정 변화에 관한 고찰 - 건국이후부터 2012년까지 -)

  • Eom, Seok-Ki
    • The Journal of Korean Medical History
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    • v.27 no.2
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    • pp.11-37
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    • 2014
  • Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.

Research Trends on Fire Engineering Design of ISO (국제 표준화 기구의 내화공학설계 연구동향)

  • Kwon, In-Kyu
    • Proceedings of the Korea Institute of Fire Science and Engineering Conference
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    • 2008.04a
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    • pp.73-75
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    • 2008
  • Fire engineering design method based on structural performance of buildings has been developed through all of the worlds since the early 1960's. But recently the worlds have been changed rapidly in aspects of global community and mutural free trade circumstances. Therefore the concepts of fire design on structural performance need to harmonize among countries that have their own unique regulations and ISO TC 92 and SC 4 have worked in order to make the united international standard.

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