• 한국임상약학회지
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• 제34권1호
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• pp.39-61
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• 2024

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA's programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA's regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.

• 한국환경독성학회:학술대회논문집
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• 한국환경독성학회 2003년도 추계국제학술대회
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• pp.127-128
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• 2003

During the past decade a reduced risk pesticide registration program has been in operation in the United States (Racke, 1992). The general principle of the reduced risk pesticide registration program in the U.S. is to give registration priority and accelerated approval to products with the most favorable characteristics as compared to currently available alternatives (EPA, 1997). The overall objective is to accelerate the introduction of these types of products so that marketplace choices rather than increased regulatory restrictions can lead to replacement of older products and technologies with newer ones. Under the program, pesticides classified as “reduced risk” products must meet several or all of the following criteria as compared with currently available alternatives: $\textbullet$ Reduced risks to human health $\textbullet$ Reduced risks to non-target organisms (e.g., fish, birds) $\textbullet$ Reduced potential for contamination of environmental resources (water, air, soil) $\textbullet$ Broadened adoption of integrated pest management

• 한국식품위생안전성학회지
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• 제1권1호
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• pp.107-113
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• 1986

It is estimated that the loss of Korean agricultural and fishery products during the storage period is usually more than 20%, and it is difficult to increase agricultural products by a 10% annual rate directly. Therefore, development of food preservation techniques has now become a most important atternative for the indirect increase of such products and for its senitary distribution. Changes eating habits and improved living conditions have accelerated the demand for convenience food production and for this reason it is essential that raw materials at stable, resonable prices and hygienic quality be available the year round. At the end of 1980, the Korean government conceded th economical feasibility of the storage of foods by irradiation and a procedure for preserving food by irradiation on a batch scale was successfully developed by KAERI in 1982. Based on the research results accomplished by the KAERI and on the recommendation on wholesomeness of irradiated food by Joint Committee of FAO/IAEA/WHO in 1980, the approval of wholesomeness of irradiated food was declared by presidential decree in June 1985 and the procedure of permission for individual items is in progress. Korean private firms (Ryung Young Co.) which was technically assisted by KAERI for five years have taken mush interest in the establishment of such facilities in Korea, therefore Ryung Young Co. had proposed for the construction of 500 Kci Co-60 irradiator to the Ministry of Science and Technology in July 1984. The permission of construction has approved by government in May 1985. The commercial irradiator will be constructed as one of the most modernized facilities until May 1987 and that facilities will contribute the propagation of commercial storage of foods and its hygienic quality.

• 융합보안논문지
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• 제13권2호
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• pp.33-43
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• 2013

한국의 민간경비 산업은 1976년 12월 31일 용역경비업법이 제정되면서 활발한 성장을 하게 되었다. 1980년대 초부터 선진국의 민간경비 기술과 자본을 도입하면서부터 급속한 성장을 하게 되었고, 86서울아시안게임, 88서울올림픽 등 국제적인 행사에 민간경호경비업체가 업무에 참여하면서 민간경호경비는 민생치안 대안으로서 미래 산업의 하나로 각광받게 되었다. 그리고 일반인에게도 대중화되어 양적인 수요도 증가하였다. 1990년대 후반부터 경비지도사신설, 교육제도개선, 신변보호업무추가 등 15차례 경비업법이 개정되면서 질적 성장을 위해 박차를 가하여, 2012년까지 3,836개의 민간경호경비회사와 150,030명의 민간경비원들이 활동을 하고 있다. 하지만 일부 회사들은 비도덕적 경호경비업무에 투입되어 행정처분을 받거나 과잉경쟁으로 인해 덤핑 현상이 나타나고 있다. 그리고 경비업법상 경비지도사의 선임기준은 영세한 업체들의 폐업 원인이 되고 있으며, 경호경비회사의 설립 허가기준이 미흡하여 신규로 법인이 설립되는 현상이 반복되고 있다. 위와 같은 문제의 해결 방안으로는 경비원들의 교육과 훈련을 통해 수준 높은 서비스제공, 신변보호 업체들의 영역확대, 경비지도사 선임기준 변경, 전문마케터를 통한 특정고객 유치, 경비원 전문 자격제도 도입, 경호경비회사 설립 허가요건 강화 등을 제시하였다.