• 한국지하수토양환경학회지:지하수토양환경
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• 제22권3호
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• pp.1-9
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• 2017

The numerical analysis of groundwater flow is indispensable for predicting problems associated with water resource development, civil works, environmental hazards, and nuclear power plant construction. Korea lacks public regulatory procedures and guidelines for groundwater flow modeling, especially in nuclear facility sites, which makes adequate evaluation difficult. Feasible step-by-step guidelines are also unavailable. Consequently, reports on groundwater flow modeling have low-grade quality and often present controversial opinions. Additionally, without public guidelines, maintaining consistency in reviewing reports and enforcing laws is more challenging. In this study, the guidelines for groundwater flow modeling were reviewed for three countries - the United States (Documenting Groundwater Modeling at Sites Contaminated with Radioactive Substances), Canada (Guidelines for Groundwater Modelling to Assess Impacts of Proposed Natural Resource Development Activities), and Australia (Australian Groundwater Modelling Guidelines), with the aim of developing groundwater flow modeling regulatory guidelines that can be applied to nuclear facilities in Korea, in accordance with the Groundwater Act, Environmental Impact Assessment Act, and the Nuclear Safety Act.

• Journal of Veterinary Science
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• 제22권1호
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• pp.6.1-6.6
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• 2021

Stem cell-based products (SCPs) are an emerging field of veterinary medicine that focuses on the regeneration, repair, or replacement of damaged tissues or organs. However, there are some issues in applying the traditional regulatory guideline for the approval of SCPs as veterinary medicinal products. This article describes the positions of Korea, US, and EU regarding SCPs, and compares the regulatory guidelines of each country for their safety evaluation. Although there are some differences in the regulatory guidelines, similar considerations in identifying the quality of SCPs and their safety has adopted. Overall, these guidelines need to be harmonized among countries.

• Nuclear Engineering and Technology
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• 제41권4호
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• pp.403-412
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• 2009

For efficient and effective nuclear regulation, regulatory organizations must establish consistent and rigorous regulatory positions on safety matters. These positions should be based on high technical expertise and relevant ordinances, standards, and guidelines reflecting policy changes governing nuclear regulations. The Korea Institute of Nuclear Safety, a regulatory expert organization in Korea, has developed regulatory requirements, guidelines and analytical tools that provide regulatory technical bases for ensuring nuclear safety. The nuclear regulatory research also contributes to regulatory decision making by providing resolution for current and future safety issues. In this article, we introduce nuclear regulatory research and its main achievements in the past 10 years. Also, suggested here are future directions of nuclear regulatory research.

• Toxicological Research
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• 제17권
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• pp.219-225
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• 2001

The basic structure for assessment of potential health risks from environmental chemicals is widely agreed upon, but many of the details of risk assessment procedures differ among practitioners. Government regulatory agencies typically have guidelines or standard procedures for their risk assessments, established to ensure consistency and comparability, to set standards for adequacy, and to embody underlying tenets. In setting and updating such guidelines, each agency takes into account not only the prevailing thinking about appropriate procedures, but also its own goals and responsibilities and the precedents it has set for itself in past analyses. This results in variations in methods, and consequently in characterization of risks, among regulatory assessments, even when they are based on the same data. As a result, adopting existing assessments from a variety of regulatory bodies needs to be done with caution. This paper examines some of the variants in risk assessment approaches among American federal regulatory agencies and relates them to the variations in regulatory responsibilities of those groups. Comparisons to international practices are also drawn. The impact on development of world-wide risk standards is discussed.

• 한국임상약학회지
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• 제15권2호
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• pp.127-138
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• 2005

This is to examine the OTC regulatory system of Korea in comparison with those of Japan, UK and US, and suggest the possible regulatory actions to harmonize it to international standards. Individual countries have their own regulatory requirements and processes far OTC application based on established drug monographs and safety profiles from clinical experiences. Categories of OTC drug monographs are being expanded with transparent establishment procedure according to detailed guidelines, and public opinions as well as professional experts for assessing appropriateness of wide usage without physician's prescription. In line with trend of self-medication worldwide, the number of OTC drugs is increasing and more efficient and professional drug review is underway in the separate OTC division in regulatory agency. For improving OTC regulatory system in Korea, settlement of optimal drug classification policy and management for encouraging OTC drug use, development of more detailed and specific guidelines for OTC drug application, expansion of OTC drug monographs, transparent process for OTC monographs establishment, and establishment of OTC division in health authority, are suggested.

• 한국건축시공학회:학술대회논문집
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• 한국건축시공학회 2017년도 추계 학술논문 발표대회
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• pp.63-64
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• 2017

Protective coatings at nuclear power plants should be designed to withstand exposure to ambient conditions during normal operation or design-basis accidents. However, there was a change in the perception of the protective coating to the revision of the Regulatory Guidelines by the NRC in July 2000. In other words, maintenance guidelines have been strengthened in order to minimize the clogging of the cooling water system due to the substances in the containment building. Therefore, KHNP, the contractor and operator of the nuclear power plant, plans to develop the coating system for nuclear power plants in accordance with the regulation, and plans to develop its own coating expert.

• 대한기계학회논문집A
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• 제34권4호
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• pp.495-499
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• 2010

이 연구에서는 우리나라 CANDU형 원전의 계속운전 규제지침을 개발하였다. CANDU 600 로형인 월성 1호기는 2012년에 30년 설계수명에 도달한다. 설계수명이후에 계속운전을 원하는 원전 사업자는 11개 인자를 포함하는 주기적안전성 평가 보고서를 제출해야 하며, 추가로 다음 사항에 대한 보고서를 제출해야 한다. (1) 경년열화 관리에 대한 범위 및 사전 검토 결과 (2) 경년열화 관리 프로그램 (3) 계속 운전기간을 포함하는 시간제한 경년열화 수명평가, (4) 운전경험 및 주요 연구결과의 반영. 이 연구에서는 상기 항목에 대한 54개의 규제지침이 개발되었다.

• Environmental Analysis Health and Toxicology
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• 제24권3호
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• pp.261-270
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• 2009

To make measurable regulatory decisions of chemicals, it is necessary to consider their effect on the human health and ecosystem. In principle, this is based on relevant toxicity studies conducted by accepted guidelines. However, current regulatory programs in various countries confront challenges related to risk assessment of large numbers of chemicals within the restricted resources and time. Therefore there is a need for more efficient approach to limit the number of tests to be conducted. This promotes the development of powerful nontesting methods (e.g. (Q)SARs) and permits to use the predicted data for regulatory purpose. In this article, current status of non-testing methods in various chemical regulatory programs was reviewed in terms of their application and research activity on them. Finally, their usefulness associated with development of domestic regulatory program was suggested.

• 보건의료산업학회지
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• 제14권1호
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• pp.55-65
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• 2020

Objectives: To provide guidance for agency planning by identifying barriers faced by Korean pharmaceutical companies in global regulatory affairs. Methods: A questionnaire survey on global regulatory affairs was administered by email to personnel at Korean pharmaceutical companies. From a total of 60, 28 responses were collected. Respondents' companies were classified as small-sized or large-sized, based on whether their annual sales amounted to KRW 100 billion. Results: Small-sized companies were experiencing greater difficulties in receiving drug approvals from advanced countries, particularly during the Investigational New Drug (IND) and Good Manufacturing Practice (GMP) processes. Conclusions: Support measures to specifically help small-sized companies enter more advanced markets and further improved global regulatory guidelines that can meet large-sized companies' expectations are needed. Moreover, domestic and global regulatory standards should be harmonized to benefit both groups.

• 한국임상약학회지
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• 제16권2호
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• pp.123-130
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• 2006

The study was aimed to recommend the ways for improving regulatory system of quasi-drugs in governmental authority by comparing with other countries. According to the regulations, the scope of quasi-drugs includes 3 categories of 1) the health aids made of textile, rubber and paper, 2) the health aids which have very minimal effects or no any effects on humans, and 3) disinfectants and pesticides. In US, these quasi-drugs in Korea are classified into 5 categories of medical device, cosmetics, OTC drugs, dietary supplements and pesticides. To improve quasi-drugs administration in Korea, it is concluded that several measures should be implemented : 1) establish clear criteria for classifying into quasi-drugs and more detailed guidelines on designation of quasi-drugs, 2) reform current regulations to meet 3-categories characteristics, supplement detailed guidelines on quasi-drugs administration for effective application process, and update relevant regulations for efficacy, safety and quality, 3) update quasi-drug monographs, 4) re-evaluate current classification of individual quasi-drugs, 5) develop comprehensive list by ingredients, 6) reform post-marketing management system for safety and quality, 7) strengthen the review agency function by increasing the number of experts, 8) develop the database for quasi-drugs for effective information management.