• 한국임상약학회지
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• 제28권2호
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• pp.146-153
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• 2018

Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.

• 한국임상약학회지
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• 제34권1호
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• pp.39-61
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• 2024

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA's programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA's regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.

• 대한예방의학회:학술대회논문집
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• 대한예방의학회 1994년도 교수 연수회(환경)
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• pp.23-56
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• 1994

Recent criticisms of the conduct and use of risk assessment by regulatory agencies have led to a wide range of proposed remedies, including changes in regulatory statutes and the development of new methods for assessing risk. The mandate to this Committee was more limited. Our objective was to examine whether alterations in institutional arrangements or procedures, particularly the organizational separation of risk assessment from regulatory decision-making and the use of uniform guidelines for inferring risk from available scientific information, can improve federal risk assessment activities. Before undertaking to determine whether organizational and procedural reforms could improve the performance and use of risk assessment in the federal government, the Committee examined the state of risk assessment and the regulatory environment in which it is performed. In this chapter, we define risk assessment and differentiate it from other elements in the regulatory process, analyze the types of judgments made in risk assessment, and examine its current government context. Because one chronic health hazard, cancer, was highlighted in the Committee's congressional mandate and has dominated public concern about public health risks in recent years, most of our report focuses on it. Furthermore, because activities in four agencies--the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), and the Consumer Product Safety Commission (CPSC)--have given rise to many of the proposals for changes in risk assessment practices, our review focuses on these four agencies. The conclusions of this report, although directed primarily at risk assessment of potential carcinogens as performed by these four agencies, may be applicable to other federal programs to reduce health risks.

• 한국건축시공학회지
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• 제10권6호
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• pp.97-107
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• 2010

누수균열은 상시 콘크리트 구조체의 거동, 물의 성분, 수압, 온도, 화학 물질 등 다양한 환경 요인의 영향이 작용함에 따라 이에 대응할 수 있는 성능을 확보한 보수재료 및 공법이 사용되어야 한다. 본 연구에서는 콘크리트 구조물은 국가적으로 유사한 공학적 특성(배합설계, 사용재료, 시공방법, 유지관리 등)을 가지고 있기 때문에, 누수균열에 대한 보수 접근도 크게 다르지 않을 것으로 보고, 향후 유지관리 전문가들의 공통적 기술 지침의 필요에 따라 자료를 개발하였다.

• 한국방사성폐기물학회:학술대회논문집
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• 한국방사성폐기물학회 2017년도 추계학술논문요약집
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• pp.133-134
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• 2017

• 한국압력기기공학회 논문집
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• 제7권4호
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• pp.57-62
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• 2011

As NPPs' operating times increase, the integrity of nuclear components is continually degraded due to aging effects of systems, structures and components. In addition, for the case of continued operation beyond design life, additional aging effects occurred during the extended operating period lead to more degradation of the integrity of nuclear components. Therefore, it is very important to mange and evaluate the aging to secure the safety of NPPs. Wolsong unit 1 is approaching to its design life of 30 years in 2012. The license renewal documents for continued operation of Wolsong unit 1 Is under reviewing now. In this paper, regulatory technologies for continued operation of Wolsong unit 1 developed by KINS will be introduced. That technologies include the safety review guidelines, regulatory guides for aging management program and regulatory program for audit calculation.

• Nuclear Engineering and Technology
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• 제51권7호
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• pp.1791-1798
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• 2019

Instrumentation and Control (I&C) systems of nuclear power plants (NPPs) have been continuously digitalized. These systems have a critical role in the operation of nuclear facilities by functioning as the brain of NPPs. In recent years, as cyber security threats to NPP systems have increased, regulatory and policy-related organizations around the world, including the International Atomic Energy Agency (IAEA), Nuclear Regulatory Commission (NRC) and Korea Institute of Nuclear Nonproliferation and Control (KINAC), have emphasized the importance of nuclear cyber security by publishing cyber security guidelines and recommending cyber security requirements for NPP facilities. As described in NRC Regulatory Guide (Reg) 5.71 and KINAC RS015, challenge response authentication should be applied to the critical digital I&C system of NPPs to satisfy the cyber security requirements. There have been no cases in which the most robust response authentication technology like challenge response has been developed and applied to nuclear I&C systems. This paper presents a challenge response authentication mechanism for a Programmable Logic Controller (PLC) system used as a control system in the safety system of the Advanced Power Reactor (APR) 1400 NPP.

• 환경영향평가
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• 제23권3호
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• pp.227-235
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• 2014

Interest has been growing worldwide in unconventional natural gas that has become an increasingly important source of energy in the world. Unconventional gas development, including shale gas, generally involves a larger environmental impact, compared to conventional gas development, due to its intensity and scale of the operation. There are a growing number of studies on identifying and minimizing the environmental impacts of unconventional gas development. This study aims to examines the current environmental policies and regulatory systems related to the unconventional gas development. The study shows that few environmental regulation exists concerning unconventional gas development, even in the USA where unconventional gas development is most actively pursued. Regulations, however, are being developed based on studies currently underway on health and environmental risks of unconventional gas development and on guidelines designed to reduce the risks. In a world where environmental regulations are ever strengthening, review the environmental regulatory systems and guidelines about unconventional gas need to be established for Korean firms to understand environmental impacts of unconventional gas development they invest or take part in, enabling them to manage and operate gas activities in a way that minimizes environmental damages.

• 한국주거학회논문집
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• 제25권4호
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• pp.1-9
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• 2014

The post-war period has witnessed the emergence of new towns in a number of countries in Southeast Asia. New town development started in Malaysia with Petaling Jaya as a satellite town in 1953 to accommodate the rapid growing population of Kuala Lumpur. New towns have been designed in accordance with the British town planning principles, based on the modern ideal city. Nonetheless, they have constituted a regional character as they have incorporated local factors such as local technologies as well as site and climatic conditions. In the shaping of the new towns in modern cities, regulatory aspects have played important roles. The regulations decide the basic framework for planning of new town, block plan and unit plan. The ultimate goal of this study is to understand the identity of the new town planning of Malaysia. As a first step, we reviewed the local regulations, standards, and design guidelines which are applicable to the new town planning from the national land use to local plans. As a result, we categorized the guidelines into four areas: urban space, site plan, street system, block plan and unit plan. We expect this study to provide the framework of the Malaysia's new town planning from the perspective of the local regulations.

• Translational and Clinical Pharmacology
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• 제26권4호
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• pp.145-149
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• 2018

Cases of drug-induced QT prolongation and sudden cardiac deaths resulted in market withdrawal of many drugs and world-wide regulatory changes through accepting the ICH guidelines E14 and S7B. However, because the guidelines were not comprehensive enough to cover the electrophysiological changes by drug-induced cardiac ion channel blocking, CiPA was initiated by experts in governments and academia in the USA, Europe, and Japan in 2013. Five years have passed since the launch of the CiPA initiative that aimed to improve the current ICH guidelines. This report reviews the current achievements of the CiPA initiative and explores unresolved issues.