• Molecules and Cells
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• v.43 no.4
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• pp.331-339
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• 2020

Genetic modifications in noncoding regulatory regions are likely critical to human evolution. Human-accelerated noncoding elements are highly conserved noncoding regions among vertebrates but have large differences across humans, which implies human-specific regulatory potential. In this study, we found that human-accelerated noncoding elements were frequently coupled with DNase I hypersensitive sites (DHSs), together with monomethylated and trimethylated histone H3 lysine 4, which are active regulatory markers. This coupling was particularly pronounced in fetal brains relative to adult brains, non-brain fetal tissues, and embryonic stem cells. However, fetal brain DHSs were also specifically enriched in deeply conserved sequences, implying coexistence of universal maintenance and human-specific fitness in human brain development. We assessed whether this coexisting pattern was a general one by quantitatively measuring evolutionary rates of DHSs. As a result, fetal brain DHSs showed a mixed but distinct signature of regional conservation and outlier point acceleration as compared to other DHSs. This finding suggests that brain developmental sequences are selectively constrained in general, whereas specific nucleotides are under positive selection or constraint relaxation simultaneously. Hence, we hypothesize that human- or primate-specific changes to universally conserved regulatory codes of brain development may drive the accelerated, and most likely adaptive, evolution of the regulatory network of the human brain.

• International Journal of Computer Science & Network Security
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• v.22 no.1
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• pp.39-48
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• 2022

Today the regulation of socio-economic development has been the subject of active scientific debate. The modern paradigm of regulatory policy in foreign countries involves a change in the role and strategy of the state, which determines the relevance of this topic. The aim of the article is to study the current state of regulatory policy research. The article is based on a bibliographic analysis of the study of regulatory policy. The study is based on the data search functions of the Scopus platform. It uses a set of VOSviewer program, online visualization of keywords in the titles of scientific journals and citations of publications. The study led to the conclusion that the number of publications that directly study the nature and features of regulatory policy is insignificant, but constantly growing. In our opinion, further research should determine the essence of regulatory policy as a separate category, a description of its features and factors of formation. It is also necessary to develop a common concept that governments should be actively involved in ensuring the quality of regulation, rather than responding to the shortcomings of regulation, which is evolving into regulatory governance.

• East Asian Economic Review
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• v.17 no.4
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• pp.385-415
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• 2013

Inter-regional free trade agreements (FTAs) - notably between Asia and Latin America - are growing in numbers and complexity. There is an absence of an agreed methodology for empirical assessments on the content of FTAs and little research. This paper proposes a framework to assess liberalization in FTAs in goods and services and new trade policy issues relating to regulatory barriers. Next, it applies this framework to studying the 22 Asia-Latin America FTAs in existence. The findings suggest that Asia-Latin American FTAs have laid the foundations for inter-regional integration by liberalizing the trade in goods and services and reducing some regulatory barriers. Deepening FTAs and adopting structural reforms will enhance Asia-Latin American integration in the future.

• Journal of Integrative Natural Science
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• v.4 no.4
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• pp.315-322
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• 2011

This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the approval of stereoisomeric drugs in Korea and US. According to the regulatory guidelines in major countries (EU, Canada, US), the important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substances 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. For this study, domestic regulatory documents for current guidelines of stereoisomeric drugs were investigated. Also four typical stereoisomeric drugs for three categories were chosen to investigate the new drug submission documents of KFDA and FDA for the safety and efficacy evaluation of stereoisomeric drugs. It is expected that these comparative results between KFDA and FDA will be useful for the safety and efficacy for the regulatory approval of stereoisomeric drugs in Korea.

• Informatization Policy
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• v.25 no.1
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• pp.60-81
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• 2018

Healthcare is on the verge of a paradigm shift towards an emphasis on wellbeing, integrative health, and prevention of disease, while the traditional medical model focuses solely on end-point treatment. The development of digital technologies has played a major role in this change as digital technology and health have converged. Therefore, many developed countries promote the digital healthcare industry as a new economic growth engine, and Korea is no exception. To promote the digital healthcare industry, the Korean government provides institutional support by improving the legal and regulatory system for medical devices and health data. However, Korea still has an underdeveloped legal and regulatory framework for digital healthcare compared with other countries. In this study, we review the relevant regulatory systems in the United States, United Kingdom, Germany, and Japan. We then explore newspaper articles and conduct expert interviews to analyze the regulatory situation in Korea and the problems the digital healthcare industry faces. In conclusion, we discuss a regulatory reform plan for development of the digital healthcare industry in Korea.

• 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.

• Nuclear Engineering and Technology
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• v.37 no.3
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• pp.221-230
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• 2005

This paper reviews the pivotal phases of the evolution of the current technology-dependent nuclear power safety regulation in the United States. Understanding of this evolution is essential to the development of any future regulatory paradigm, including the technology-neutral regulatory approach that the U.S. Nuclear Regulatory Commission (NRC) has recently embarked on to develop. The paper proposes and examines the implications of a predominately rationalist and best-estimate probabilistic regulatory framework called safety goals-driven performance-based regulation. This framework relies on continuous assessment of performance of a set of time-dependent safety-critical systems, structures and components that assure attainment of a broad set of technology-neutral protective, mitigative, and preventive goals. Finally, the paper discusses the steps needed to develop a corresponding technology-neutral regulatory system from the proposed framework.

• Journal of Veterinary Science
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• v.22 no.1
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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.

• Molecules and Cells
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• v.39 no.4
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• pp.358-366
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• 2016

The digestive system is gaining interest as a major regulator of various functions including immune defense, nutrient accumulation, and regulation of feeding behavior, aside from its conventional function as a digestive organ. The Drosophila midgut epithelium is completely renewed every 1-2 weeks due to differentiation of pluripotent intestinal stem cells in the midgut. Intestinal stem cells constantly divide and differentiate into enterocytes that secrete digestive enzymes and absorb nutrients, or enteroendocrine cells that secrete regulatory peptides. Regulatory peptides have important roles in development and metabolism, but study has mainly focused on expression and functions in the nervous system, and not much is known about the roles in endocrine functions of enteroendocrine cells. We systemically examined the expression of 45 regulatory peptide genes in the Drosophila midgut, and verified that at least 10 genes are expressed in the midgut enteroendocrine cells through RT-PCR, in situ hybridization, antisera, and 25 regulatory peptide-GAL transgenes. The Drosophila midgut is highly compartmentalized, and individual peptides in enteroendocrine cells were observed to express in specific regions of the midgut. We also confirmed that some peptides expressed in the same region of the midgut are expressed in mutually exclusive enteroendocrine cells. These results indicate that the midgut enteroendocrine cells are functionally differentiated into different subgroups. Through this study, we have established a basis to study regulatory peptide functions in enteroendocrine cells as well as the complex organization of enteroendocrine cells in the Drosophila midgut.

• Nuclear Engineering and Technology
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• v.55 no.11
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• pp.4083-4095
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• 2023

Currently, various research institutes in Korea are conducting research to develop a safety case for deep geological repository for high-level radioactive waste (HLW). In the past, low and intermediate-level waste (LILW) was approved by a regulatory body by performing a post-closure safety assessment, but HLW has different disposal characteristics and safety objectives are different. Therefore, in the case of HLW, safety assessment should be performed based on these changed conditions, and specific procedures are also under development. In this paper, the regulatory status of prior research institutes, feature, event and process (FEP) and scenario development cases were investigated for well-organized FEP and scenario development methodologies. In addition, through the results of these surveys, the requirements and procedures necessary for the FEP and scenario development stage during the safety assessment of repository for HLW were presented. These review results are expected to be used to identify the overall status of previous studies in conducting post-closure risk assessment for HLW repository, starting with identifying regulatory requirements, the most basic element.