• Nuclear Engineering and Technology
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• 제40권5호
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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.

• 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.

• 한국임상약학회지
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• 제31권4호
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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.

• International Journal of Aeronautical and Space Sciences
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• 제15권1호
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• pp.54-62
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• 2014

The Air and Space Interoperability Council (ASIC) has adopted the European Defence Agency (EDA) process for inter-regulatory military airworthiness authority recognition. However, there are gaps in the application of this process to nations outside of the European Union. This paper proposes a model that can effectively map diverse technical airworthiness regulatory frameworks. This model, referred to as the Product-Behaviour-Process (PBP) Bow-Tie model, provides the systematic structure needed to represent and compare regulatory frameworks. The PBP Bow-Tie model identifies key points of difference that need to be addressed, during inter-agency recognition between the two regulatory authorities. With the intention to adopt global use of the EDA process, the proposed PBP Bow-Tie model can be used as a basis for the successful recognition of regulatory frameworks outside of the European Union. Iris plots produced from the implementation of this model are presented, and proposed as a suitable means of illustrating the outcome of an assessment, and of supporting the comparisons of results. A comparative analysis of the Australian Defence Force and New Zealand Defence Force airworthiness regulatory frameworks is used as a case study. The case study clearly illustrates the effectiveness of the model in discerning regulatory framework differences; moreover, it has offered an opportunity to explore the limitations of the Iris plot.

• 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.

• 대한수의학회지
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• 제55권2호
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• pp.97-103
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• 2015

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

• 규제연구
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• 제27권2호
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• pp.71-104
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• 2018

자원제약에 대한 규제기관의 대응행태는 규제의 효과성 측면에서 중요한 이슈임에도 불구하고 체계적인 연구가 부족하다. 본 연구는 이러한 한계를 벗어나기 위한 노력으로서 규제자원이 제약된 상황에 대응한 규제기관의 행태를 시론적으로 제시하는 데에 주된 목적을 두었다. 구체적으로, 규제이론과 조직이론에 기반한 선행연구를 비판적으로 검토하여 자원이 부족한 상태에서 나타날 가능성이 있는 규제기관의 행태(규제과정상의 변화, 집행방식의 변화, 비동조화, 규제위임과 민간위탁)를 제시하였다. 이 과정에서 주로 해운규제분야 사례들을 통해, 도출한 대응행태의 현실적인 설명가능성을 살펴보았으며, 자원제약에 대응한 규제기관의 행태가 가져올 수 있는 문제점에 대해서도 논의하였다. 연구결과를 토대로 규제자원의 부족 상태에서 규제기관이 보일 행태를 고려하여 규제의 효과성을 보다 담보할 수 있는 규제체계를 설계할 필요가 있다는 시사점을 제시하였다. 본 연구는 향후 실제 자원제약을 받고 있는 우리나라 규제기관들의 행태를 실증적으로 분석할 수 있는 이론적 분석틀을 마련하는 데에 도움을 주리라 기대한다.

• Journal of the Korean Data and Information Science Society
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• 제22권1호
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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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• 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.

• 한국지형공간정보학회:학술대회논문집
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• 한국지형공간정보학회 2005년도 아시아 태평양 국제 GSIS 학술발표회
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• pp.1-7
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• 2005