• KDI Journal of Economic Policy
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• v.39 no.4
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• pp.51-68
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• 2017

This paper adapts the World Bank Regulatory Quality Index (RQI), which is produced annually to provide a better understanding of the effects of regulatory reforms, instead of the Production Market Regulation (PMR) indicators, which are published every five years. We find that 9.9 to 36.0 billion USD worth of regulatory cost could be reduced if the regulatory quality in Korea improves to the level of the OECD average considering that the total burden of regulation in Korea is estimated to range from 2.2 to 357.4 billion USD. The estimated reduction in the regulatory cost accounts for roughly 0.76 to 2.47% of Korea's GDP in 2013, underscoring the importance of regulatory reforms for the Korean economy. This paper introduces a new method with which to examine the distribution of regulatory costs across different industries and firm sizes. This alternative method is largely consistent with the conclusions reached by other studies, specifically that small firms typically bear a disproportionate regulatory burden.

• Korean Journal of Clinical Pharmacy
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• v.31 no.4
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• pp.257-267
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• 2021

Background: The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. Results: The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees' ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia's regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. Conclusion: Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea's independent concept of regulatory science.

• Korean Journal of Clinical Pharmacy
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• v.31 no.3
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• pp.171-179
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• 2021

Background: Need for regulatory science is emerging with the development of pharmaceutical industry. It is essential to train regulatory science experts to meet the needs of technology and regulations to evaluate advanced products. Major regulatory science countries are conducting the regulatory science activities and fostering the experts. Methods: Published literature and the relevant website of European Union (EU) were reviewed and criteria were developed. In particular, we focused on in depth descriptions of the Innovative Medicines Initiative program, which was conducted twice. Results: EU is striving to provide funding and training experts for the development of the regulatory science by horizon 2020 and regulatory science to 2025. Innovative medicines initiative (IMI) is a public-private partnership aimed at the development of the pharmaceutical industry, including the regulatory science. IMI education and training projects have provided various education and training course including short-term curriculum and master and doctoral course. The difference between South Korea's regulatory science expert training project in 2021 and the EU's IMI education and training projects is participation of pharmaceutical companies. While the pharmaceutical companies participate in the IMI project to select project topics and form a community, South Korea's project is focused on the Ministry of Food and Drug Safety and universities. Conclusion: Through successful active networks with regulatory party, pharmaceutical companies, and universities, a great innovative advance of regulatory science in South Korea is expected.

• KDI Journal of Economic Policy
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• v.45 no.1
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• pp.69-86
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• 2023

Regulatory sentiment refers to the market's subjective evaluation of regulatory reform and is one of the most widely adopted indicators to those charged with implementing and diagnosing regulatory policies. The use of regulatory sentiment in advanced analysis has become universal, albeit it is often limited due to difficulties in articulating consistent and objective quantitative indicators that can meticulously reflect market sentiment overall. Thus, despite ample effort by scholars to read the economic impact of regulatory sentiment in the real economy, causal links are difficult to spot. To fill this gap in the literature, this study analyzes a regulatory sentiment index and economic performance indicators through a text analysis approach and by inspecting diverse tones in media articles. Using different stages of tests, the paper identifies a causal relationship between regulatory sentiment and actual economic activities as measured by private consumption, facility investment, construction investment, gross domestic investment, and employment. Additionally, as a result of analyzing one-unit impulse of regulatory perception, the initial impact on economic growth and private investment was found to be negligible; this was followed by a positive (+) response, after which it converged to zero. Construction investment showed a positive (+) response initially, which then rapidly changed to a negative (-) response and then converged to zero. Gross domestic investment as the initial effect was negligible after showing a positive (+) reaction. Unfortunately, the facility investment outcome was found to be insignificant in the impulse response test. Nevertheless, it can be concluded that it is necessary and important to increase the sensitivity to regulations to promote the economic effectiveness of regulatory reforms. Thus, instead of dealing with policies with the vague goal of merely improving regulatory sentiment, using regulatory sentiment as an indicator of major policies could be an effective approach.

• Nuclear Engineering and Technology
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• v.40 no.5
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• pp.349-364
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• 2008

Over the years, probabilistic risk assessment (PRA) research activities conducted at the U.S. Nuclear Regulatory Commission (NRC) have played an essential role in support of the agency's move towards risk-informed regulation. These research activities have provided the technical basis for NRC's regulatory activities in key areas; provided PRA methods, tools, and data enabling the agency to meet future challenges; supported the implementation of NRC's 1995 PRA Policy Statement by assessing key sources of risk; and supported the development of necessary technical and human resources supporting NRC's risk-informed activities. PRA research aimed at improving the NRC's understanding of risk can positively affect the agency's regulatory activities, as evidenced by three case studies involving research on fire PRA, human reliability analysis (HRA), and pressurized thermal shock (PTS) PRA. These case studies also show that such research can take a considerable amount of time, and that the incorporation of research results into regulatory practice can take even longer. The need for sustained effort and appropriate lead time is an important consideration in the development of a PRA research program aimed at helping the agency address key sources of risk for current and potential future facilities.

• YAKHAK HOEJI
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• v.55 no.5
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• pp.426-431
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• 2011

This study was performed to investigate the current regulatory guidances of safety and efficacy evaluation for the development and approval of stereoisomeric drugs in US, EU, Canada and Japan. The important categories for the development of stereoisomeric drugs are classified as 1) development of a single enantiomer as a new active substance 2) development of a racemate as a new active substance 3) development of a new single enantiomer from an approved racemate. The regulatory documents adopted in major countries for the safety and efficacy evaluation of stereoisomeric drugs were investigated with the focus on three major categories mentioned above. For the regulatory approval of stereoisomeric drugs in Korea, it is expected that the investigated results obtained in this study will be useful for the basic materials to ensure the safety and efficacy of stereoisomeric drugs as well as the stereochemical issues in chiral drug development in domestic pharmaceutical company.

• Environmental Analysis Health and Toxicology
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• v.24 no.3
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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.

• Journal of Environmental Impact Assessment
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• v.2 no.2
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• pp.95-103
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• 1993

EIA has been introduced as a tool for environment protection into promulgation of the Environment Preservation Act in 1977, which replaced the Pollution Control Act in Korea. EIA system has been improved with the enlargement of project type, public participation, guideline improvement, and regulatory development. Recently, Environmental Impact Assessment(EIA) Act will have an important role for sustainable development. This article deals with regulatory development, implementation order, EIA project type, and EIS preparation guidelines by Act promulgated and amended, also it explains comparison analysis of Environmental Policy Act and Environment Impact Assessment Act Major results are summarized in the table.

• Mycobiology
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• v.37 no.3
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• pp.171-182
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• 2009

Many aspergilli that belongs to ascomycetes have sexuality. In a homothallic or self-fertile fungus, a number of fruiting bodies or cleistothecia are formed in a thallus grown from a single haploid conidia or ascospores. Genome-sequencing project revealed that two mating genes (MAT) encoding the regulatory proteins that are necessary for controlling partner recognition in heterothallic fungi were conserved in most aspergilli. The MAT gene products in some self-fertile species were not required for recognition of mating partner at pheromone-signaling stage but required at later stages of sexual development. Various environmental factors such as nutritional status, culture conditions and several stresses, influence the decision or progression of sexual reproduction. A large number of genes are expected to be involved in sexual development of Emericella nidulans (anamorph: Aspergillus nidulans), a genetic and biological model organism in aspergilli. The sexual development process can be grouped into several development stages, including the decision of sexual reproductive cycle, mating process, growth of fruiting body, karyogamy followed by meiosis, and sporulation process. Complicated regulatory networks, such as signal transduction pathways and gene expression controls, may work in each stage and stage-to-stage linkages. In this review, the components joining in the regulatory pathways of sexual development, although they constitute only a small part of the whole regulatory networks, are briefly mentioned. Some of them control sexual development positively and some do negatively. Regarding the difficulties for studying sexual differentiation compare to asexual one, recent progresses in molecular genetics of E. nidulans enlarge the boundaries of understanding sexual development in the non-fertile species as well as in fertile fungi.

• KDI Journal of Economic Policy
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• v.41 no.3
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• pp.39-75
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• 2019

An emphasis on public-private partnership (PPP) in the regulatory policy process can overcome the challenges hindering regulatory effectiveness with the emergence of fast developing technologies and new industries. This study attempts to evaluate quantitatively different aspects of institutional settings of South Korean regulatory policy in terms of stakeholder engagement as PPP, using evidence-based data released by the OECD. From the results of the principal component analysis, South Korea can be evaluated as being at a very good level overall in its institutional establishment. Nevertheless, the fact that the outcome of regulatory reforms in South Korea is still insufficient compared with this well-established system suggests that the country should concentrate on improving system operation. Consequently, this study makes policy suggestions to improve regulatory effectiveness through PPP by supplementing the facets that are well-equipped but not feasible with respect to regulatory policy cycle, regulatory governance, regulatory method, and conflict resolution.