• Journal of the Korean Data and Information Science Society
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• v.22 no.1
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• pp.125-136
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• 2011

Ground-level ozone, an air pollutant that is monitored by the Environmental Protection Agency (EPA), damages human health by irritating the respiratory system, reducing lung function, damaging lung cells, and aggravating asthma and other chronic conditions. In March 2008, the EPA strengthened ozone standards by lowering acceptable limits from 84 parts per billion to 75 parts per billion. Here epidemiologic data is used to study the effects of ozone regulation on human health and assessed how various regulatory standards for ozone may affect nonaccidental mortality, including respiratory-related deaths during ozone season. The assessment uses statistical methods based on hierarchical Bayesian models to predict the potential effects of the different regulatory standards. It also analyzes the variability of the results and ho they are impacted by different modeling assumptions. We focused on the technical an statistical approach to assessing relationship between new ozone regulations and mortality while other researches have detailed the relationship between ozone and human mortality. We shows a statistical correlation between ozone regulations and mortality, with lower limits of acceptable ozone linked to a decrease in deaths, and projects that mortality is expected to decrease by reducing ozone regulatory standards.

• Toxicological Research
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• v.17
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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.

• Journal of the Korea Institute of Information and Communication Engineering
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• v.11 no.9
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• pp.1634-1641
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• 2007

In this paper, We examine the point at issue of domestic telecommunications and standards. In Korea, since we can't lighten effectively the regulatory due to operate separately both of Regulations and Standards, we should convert regulation regulatory into standard regulatory through the correlation between Regulations and Standards. In the view of expected effect, practical use for consolidating the establishment and amendment of the national telecommunications standards, and making the consolidation plan of standardization Acts and practical use for making the correlation plan between the telecommunication regulations and standards.

• Journal of Radiation Protection and Research
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• v.28 no.3
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• pp.247-254
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• 2003

To prevent the potential health detriment to the public from radioactive effluents, radiological dose assessments due to the operation of nuclear facilities located at Korea Atomic Energy Research Institute (KAERI) site has been performed semiannually in compliance with the Minister of Science and Technology (MOST)'s Notice in Korea. Radiological dose assessment based on the new recommendation of the International Committee on Radiation Protection (ICRP-60) has been conducted since 1998. In this manuscript, a serial activities at KAERI site to meet the regulatory standards for routine releases of radioactive effluents are introduced and discussed including technical approaches. It is clear that each nuclear facility has been operated in compliance with regulatory standards. Furthermore, it is identified that the radiation induced health effects for residents around the site are neglectable.

• Nuclear Engineering and Technology
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• v.41 no.4
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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.

• Journal of Biomedical Engineering Research
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• v.44 no.3
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• pp.204-210
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• 2023

This study focuses on analyzing medical device standards and regulatory requirements in the medical device industry, based on the Medical Device Act in Korea. The objective of this analysis is to determine whether the domestic standards for medical devices in Korea align with international and regional standards. Furthermore, it aims to identify the current application of domestic standards in ensuring the safety and essential performance of medical devices. The analysis revealed that out of a total of 281 domestic standards, 127 standards reference international standards. In terms of the application of domestic standards to specific items, there were 473 types of instruments/machines, 30 types of medical supplies, and 45 types of dental materials. However, the level of compliance with international standards among the domestic medical device standards was only 21%. Upon detailed analysis, general and collateral standards accounted for 24%, while particular standards accounted for 19%. This indicates a significant deviation from the latest international standards. On the other hand, the level of compliance with international standards was analyzed to be 60% for particular standards and 72% for general and collateral standards in Korean industrial standards (KS). Considering these results, the disparities between domestic standards and international standards underscore the need for discussions on domestic medical device regulation and standardization. In conclusion, this study emphasizes the significance of maintaining up-to-date medical device standards and ensuring their alignment with international standards to ensure the safety and quality of medical devices. The findings highlight the necessity for further efforts to strengthen the domestic standardization system in order to promote the development of safe and high-quality medical devices.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.36
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• pp.195-262
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• 2007

This paper attempts to assess the Basel Committee's bank supervisory standards and capital adequacy rules, and thereby rethink whether global convergence in banking regulation is desirable. To that end, it seeks to address the impetus for the creation of the Basel Committee, and explore driving forces behind the internationalization of bank regulatory and supervisory standards. Following the historical and theoretical analysis of the internationalization of bank regulatory standards, the movement toward global standards in banking is reviewed. More importantly, this paper seeks to explore the origins of the Basel Accord on bank capital adequacy. To do so, it largely relies on current theories on the process of negotiating the capital adequacy standards in the areas of political science and international political economy. At this point, this study takes a position as a break against the force of international market failure logic that has enjoyed an exceptionally positive reception among economists, political scientists, and legal experts. Nonetheless, it does not intend to freeze the international coordination and cooperation of banking regulation. Given the understanding of the politics behind the creation of the Basel Accord, this paper evaluates the Basel Accord of 1988 and the new capital adequacy framework(Basel II), and then moves beyond the assessment of the capital adequacy standards In doing so, this study draws lessons from Basel in search of a just world order in the global finance.

• The Korean Journal of Health Service Management
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• v.14 no.1
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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.

• International Journal of Stem Cells
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• v.17 no.2
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• pp.120-129
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• 2024

Recent amendments to regulatory frameworks have placed a greater emphasis on the utilization of in vitro testing platforms for preclinical drug evaluations and toxicity assessments. This requires advanced tissue models capable of accurately replicating liver functions for drug efficacy and toxicity predictions. Liver organoids, derived from human cell sources, offer promise as a reliable platform for drug evaluation. However, there is a lack of standardized quality evaluation methods, which hinders their regulatory acceptance. This paper proposes comprehensive quality standards tailored for liver organoids, addressing cell source validation, organoid generation, and functional assessment. These guidelines aim to enhance reproducibility and accuracy in toxicity testing, thereby accelerating the adoption of organoids as a reliable alternative or complementary tool to animal testing in drug development. The quality standards include criteria for size, cellular composition, gene expression, and functional assays, thus ensuring a robust hepatotoxicity testing platform.

• Journal of Radiation Protection and Research
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• v.28 no.1
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• pp.65-73
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• 2003

The paper discusses results of recent international intercomparison exercises on internal dose assessments, status of up to date internal dosimetry methods and the radiological legislation developed and implemented in Korea, European Union and Ukraine. The system of radiation protection in Korea is based on the Korean Atomic Energy Regulatory Enforcement on Safety Standards (Ministry Notice No. 2001-2). The notice is based on the recommendations in ICRP Publication 60 (1990) and IAEA Basic Safety Standards (1996). But the full implementation of the notice by the end of the year 2002 is not required because of the socio-economic situation and inexperience in internal radiation dosimetry Regulatory framework for internal radiation dosimetry is under development toward the full implementation of the notice from January 1, 2003. The system of radiation protection in Ukraine is based on the National radiation protection regulatory code NRBU-97. The code was developed and adopted in 1998 and replaced the Regulations of Former Soviet Union. The document is based on the ICRP Publication 60, Euratom Directive 96/29 and IAEA Basic Safety Standards (1996). The transitional period of 5 years (effected till January 2003) is established for implementation of all requirements of this new regulation. The system of radiation protection in the European Community is based on the Council Directive 96/29/Euratom, adopted in 1996 and enforced from 13 May 2000. Directive 96/29/Euratom has the status of the European law.