• 제목/요약/키워드: Regulatory framework

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A Study on the Appropriateness of Regulatory Impact Analysis(RIA) on Technological Regulation: With the Focus on the Technological Regulation Impact Assessment (기술규제 규제영향분석의 적절성에 대한 연구: 기술규제영향평가 차원에서)

  • Lee, Ji-Eun;Kim, Tae-Yun
    • Journal of Technology Innovation
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    • 제25권3호
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    • pp.233-263
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    • 2017
  • The purpose of this study is to examine the appropriateness of Regulatory Impact Analysis(RIA) in terms of the technological regulation impact assessment in order to confirm whether the current RIA process reflects the important characteristics of technological regulation. This paper develops a logical framework for analysis of technological regulation and evaluates the appropriateness of the RIA statements submitted by the government departments. From the viewpoint of [technological feasibility of regulation], [synthesis of domestic technological norms], [synthesis of international technological norms], as a result of evaluating the contents of the actual RIA statement on the basis of objective facts, feasibility of alternative analysis, and expert judgment, only 23.4% of the RIA statements were judged "appropriate", and there were no particular differences among the government. As a result of reviewing the appropriateness of RIA statements according to regulatory attributes, the appropriateness of RIA statements on technological regulation with social regulatory and indirect regulatory attributes was rather high. In sum, the level of Korean RIA statements is insufficient to carry out the practical meaning of technological regulation impact assessment. That is, as each government department adopts technological regulation, the understanding of the technological properties of the regulation may not be complete. The RIA statement that does not adequately reflect the technological rationale, hinders the careful review of other regulatory alternatives by exaggerating the feasibility of the technology regulation, at the same time leads to the serious problems that impede the acquisition of competitiveness of companies and the public in the global competition system.

Determinants of E-Government Assimilation in Indonesia: An Empirical Investigation Using a TOE Framework

  • Pudjianto, Boni;Zo, Hangjung;Ciganek, Andrew P.;Rho, Jae-Jeung
    • Asia pacific journal of information systems
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    • 제21권1호
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    • pp.49-80
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    • 2011
  • E-government needs to be successfully implemented and assimilated into organizations to take advantage of its potential values and benefits for organizations. This study examines factors for e-government assimilation in Indonesia and employs the TOE (Technology-Organization-Environment) framework to develop a theoretical model to explain e-government assimilation. It also investigates how organizational type (central vs. local) plays a role in the assimilation of e-government. One hundred eighteen respondents from the central and local governments in Indonesia participated in the survey and an in-depth analysis based on partial least squares (PLS) was carried out. The results show that ICT infrastructure has the strongest significant relationship with e-government assimilation, Top management support, regulatory environment, ICT expertise, and competitive environment are also significant factors to explain e-government assimilation in Indonesia. Central and local governments Significantly differ in terms of e-government assimilation, so organizational type can be a moderator in the process of e-government assimilation. These findings present the efficacy of the proposed model for analyzing e-government assimilation and contribute additional insights for academia as well as practitioners and policy makers.

Development of an Accident Consequence Assessment Code for Evaluating Site Suitability of Light- and Heavy-water Reactors Based on the Korean Technical Standards

  • Hwang, Won Tae;Jeong, Hae Sun;Jeong, Hyo Joon;Kil, A Reum;Kim, Eun Han;Han, Moon Hee
    • Journal of Radiation Protection and Research
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    • 제41권4호
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    • pp.368-372
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    • 2016
  • Background: Methodologies for a series of radiological consequence assessments show a distinctive difference according to the design principles of the original nuclear suppliers and their technical standards to be imposed. This is due to the uncertainties of the accidental source term, radionuclide behavior in the environment, and subsequent radiological dose. Both types of PWR and PHWR are operated in Korea. However, technical standards for evaluating atmospheric dispersion have been enacted based on the U.S. NRC's positions regardless of the reactor types. For this reason, it might cause a controversy between the licensor and licensee of a nuclear power plant. Materials and Methods: It was modelled under the framework of the NRC Regulatory Guide 1.145 for light-water reactors, reflecting the features of heavy-water reactors as specified in the Canadian National Standard and the modelling features in MACCS2, such as atmospheric diffusion coefficient, ground deposition, surface roughness, radioactive plume depletion, and exposure from ground deposition. Results and Discussion: An integrated accident consequence assessment code, ACCESS (Accident Consequence Assessment Code for Evaluating Site Suitability), was developed by taking into account the unique regulatory positions for reactor types under the framework of the current Korean technical standards. Field tracer experiments and hand calculations have been carried out for validation and verification of the models. Conclusion: The modelling approaches of ACCESS and its features are introduced, and its applicative results for a hypothetical accidental scenario are comprehensively discussed. In an applicative study, the predicted results by the light-water reactor assessment model were higher than those by other models in terms of total doses.

Comparison of Approval Process for Nonprescription Drugs in Different Countries (비처방의약품 허가 제도의 국가별 비교 연구 및 고찰)

  • Kim, Joo Hee;Yee, Jeong;Lee, Gwan Yung;Lee, Kyung Eun;Gwak, Hye Sun
    • Korean Journal of Clinical Pharmacy
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    • 제28권4호
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    • pp.263-272
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    • 2018
  • Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.

A Study on Domestic Policy Framework for Application of Carbon Dioxide Capture and Storage(CCS) (이산화탄소 포집 및 저장 실용화를 위한 국내 정책 연구)

  • Chae, Sun-Young;Kwon, Suk-Jae
    • Journal of the Korean Society of Marine Environment & Safety
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    • 제18권6호
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    • pp.617-625
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    • 2012
  • This study examines the current status and policy development of Carbon Dioxide Capture and Storage(CCS), which is a technology to mitigate climate change, in Korea and foreign countries. It also analyzes IEA CCS regulatory framework as a guideline and provides limitations and implications for marine geological storage in the Republic of Korea. Although CCS master plan is established at national level, related laws are not amended and detailed polices are not yet provided. Established 'Intergovernmental CCS committee' lacks its cooperative mechanism and flexibility. Only limited and segmented economic analyses are performed and funding for large scale of CCS project is not secured. In addition, information sharing is limited and public awareness activities are insufficient. Therefore, this paper provides some policy suggestions on establishing a legal framework based on the 'Marine Environmental Management Act', strengthening the role of intergovernmental CCS committee, conducting CCS economic analysis based on various scenarios, providing economic incentives and public participation strategies, and establishing a specialized agency for information sharing.

Competition and Diversity: Perspective of the Objectives of Broadcasting-related Laws (경쟁과 다양성: 방송관련법의 목적의 관점)

  • Hong, Dae-Sik
    • Journal of Legislation Research
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    • 제44호
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    • pp.63-101
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    • 2013
  • This article firstly explores into the concepts, components, and pictures of institutional realization of competition and diversity respectively on the premise that competition and diversity comprise the primary objectives to be pursued by the broadcasting-related laws which provide the concrete measures of media policy, and argues that while the competition objective has differentiation factors, there are also particularities in the diversity value in the broadcasting-related laws as sector-specific competition laws. Then assuming that special competition rules including structural regulatory measures particularly in the broadcasting market are required in order to realize values of competition and diversity harmoniously, this article suggests the following improvement directions for regulations aimed at protection of competition and diversity in the broadcasting-related laws. The first one is with the improvement method for regulations aimed at protection of competition. Regulation on share of audience as an ex ante regulation of status and regulation on prohibited activities as an ex post regulation of conduct may play important roles in substituting the causative regulation while seeking for diversity value. For this purpose, it is needed to develop a concrete method that incorporates diversity-related factors as consideration factors in the standard for determining illegality of prohibited activities by inference to methods of determining illegality in the competition law. The second one is with the improvement method for regulations aimed at protection of diversity. This could be considered from three viewpoints that are the setting of regulatory objectives, the identification of alternative regulatory measures, and the choice of regulatory measures and levels suitable for regulatory objectives. From these viewpoints, the regulatory framework should be improved mainly with institutional measures in which diversity value is used for tools of assessment and analysis, not just remaining as mere rhetorical devices, and whether or to what extent to maintain regulations seemingly unreasonable in terms of harmonization with economic objectives such as competition should be discreetly reviewed.

Rethinking Global Convergence in Bank Regulation (은행규제의 세계적 수렴에 대한 고찰)

  • Pak, In-Sop
    • THE INTERNATIONAL COMMERCE & LAW REVIEW
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    • 제36권
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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.

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A Critical Analysis on Capital Market Developments in India: Pre and Post Liberalization Period

  • Potluri, Rajasekhara Mouly;Pasha, Shaik Abdul Majeeb;Challa, Siva kumar;Challagundla, Srilakshmi
    • Journal of Distribution Science
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    • 제12권10호
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    • pp.5-9
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    • 2014
  • Purpose - This paper aims to critically examine capital market developments in India before and after liberalization. Research design, data, and methodology - The paper examines the Indian capital market from its inception to the latest developments related to both primary and secondary markets, and also discusses recent initiatives of capital markets to enhance the expected level of services to the investor community. It also sheds light on the regulatory framework for investor protection. Results - The study further highlights the future roadmap for the radical development of the Indian capital market. The paper identifies the various initial obstacles and intricacies that affect the smooth functioning of the Indian capital markets. Hence, the paper articulates that these concerns should be addressed by the regulatory authorities and at the policy level at the earliest for further strengthening the capital markets in the interests of the economy in general and retail investors in particular. Conclusion - This is a topic of utmost contemporary importance to worldwide national economies, and calls for novel methods and techniques in dealing effectively with the menace facing capital markets.

Individual and collective responsibility to enhance regulatory compliance of the Three Rs

  • Choe, Byung In;Lee, Gwi Hyang
    • BMB Reports
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    • 제47권4호
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    • pp.179-183
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    • 2014
  • Investigators planning to use animals in their research and the Institutional Animal Care and Use Committee (IACUC) members who review the research protocols must take personal responsibility for ensuring that they have the skills and knowledge to perform their duties, applying the Three Rs principles of Russell and Burch. The two Korean laws introduced in 2008 and 2009 regulating animal use for scientific purposes in line with the Three Rs principles have been revised a total of 11 times over the last 6 years. Both regulatory agencies, e.g., the Animal and Plant Quarantine Agency and the Ministry of Food and Drug Safety, provide regular training based on the legal requirements. Based on the amended Animal Welfare Act, the IACUC appointment framework has been upgraded: appointments are now for two-year terms and require a qualified training certificate issued by the Animal and Plant Quarantine Agency since 2012. The authors reviewed the current curricular programs and types of training conducted by the two governing agencies through Internet searches. Our Internet survey results suggest that: a) diversity should be provided in training curricula, based on the roles, backgrounds and needs of the individual trainees; b) proper and continued educational programs should be provided, based on trainees' experiences; and c) active encouragement by government authorities can improve the quality of training curricula.

A Study on the Enforcement and Characteristics of Environmental Criminal Law in the U.S.A. (미국 환경형법의 특성과 강제절차)

  • 이경호
    • Journal of the Korean Society of Marine Environment & Safety
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    • 제5권1호
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    • pp.59-78
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    • 1999
  • Although recently vigorous studies on environmental crime have contribute criminal respects to be advanced in our country, most of them are focused on German discussions about the theory of environmental crime or environmental criminal law. As each countries in criminal legislation for environmental protection have some distinctive characteristics not found in others, the study which is more helpful to regulate environmental crime can be extend to other country in the view of comparative law. Thus this Article overviews especially the environmental criminal enforcement program involving civil and administrative enforcement in the United States. Notwithstanding that enforcement is an evolving phenomenon that only recently appeared on the scene, there is widespread public support for it. Once viewed as mere economic or regulatory offence lacking an element of moral delict, environmental crimes now provoke moral outrage and prompt demands for severe sanction and strict enforcement. Many major provisions of modem environmental acts that imposed criminal liability have been added or significantly restructured during the last decade. Notable among them are the imposition of the felony penalties for federal environmental crimes and the enactment of the endangerment crime in federal environmental law. This Article approaches the characteristics of environmental criminal enforcement form introducing major federal environmental acts. It develops the result that, considering the difference that exist between Korea and United States in environmental criminal law, our proper environmental regulatory framework can be constituted.

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