• Environmental Analysis Health and Toxicology
• /
• 제24권3호
• /
• pp.261-270
• /
• 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.

• 한국임상약학회지
• /
• 제34권1호
• /
• pp.39-61
• /
• 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.

• 간호행정학회지
• /
• 제10권4호
• /
• pp.437-448
• /
• 2004

Purpose: The study was done to develop the model of regulatory body of advanced practice registered nurse. Method: This was a descriptive study adopted a method of comparison and construction of laws. Result: The type of partnership of government and people were privatization, negotiated rule-making, standard-setting authority, self-regulation. The pattern of partnership were applied to the regulatory body's role; administration of certification and examination, setting standards for nursing education programs and approval nursing programs. The regulatory body of advanced practice registered nurse was organized according to it's role. Conclusions: It is needed to proceed to self-regulation step by step.

• Nuclear Engineering and Technology
• /
• 제15권2호
• /
• pp.154-159
• /
• 1983

The principles and practices of national nuclear regulatory agencies around the world differ significantly. This paper outlines the philosophical approach to nuclear regulation of the Atomic Energy Control Board of Canada and attempts to explain the principles which have governed the Board's licensing and compliance programs during the past 37 years.

• Nuclear Engineering and Technology
• /
• 제56권2호
• /
• pp.426-436
• /
• 2024

Nuclear security has been emphasized to ensure the safety of the environment and humans, as well as to protect nuclear materials and facilities from malicious attacks. With increasing utilization of nuclear energy and emerging potential threats, there has been a renewed focus on nuclear security. Korea has made efforts to enhance the regulatory oversight processes, both for general and specific legislative systems. While Korea has demonstrated effective nuclear security activities, continuous efforts are necessary to maintain a high level of security and to improve regulatory efficiency in alignment with international standards. In this study, the comprehensive regulatory oversight framework for the security of Korean nuclear facilities has been investigated. For reference, the U.S. regulatory oversight frameworks for nuclear facilities, with a focus on nuclear security, and the motivations of changes in regulatory oversight framework have been identified. By comparing these regulatory programs and frameworks, insights and considerations for enhancing nuclear security regulations have been identified. A comprehensive security inspection program tailored for the Korean regulatory oversight framework has been proposed, and has been preliminarily applied to hypothetical conditions for further discussion.

• 한국원자력학회:학술대회논문집
• /
• 한국원자력학회 2003년도 춘계학술발표대회 요약집
• /
• pp.196.1-196.1
• /
• 2003

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

• 한국IT서비스학회지
• /
• 제22권5호
• /
• pp.51-70
• /
• 2023

The Personal Information Protection Commission has been promoting the adoption of co-regulation to replace/improve the existing self-regulation programs since 2022. While the Commission's co-regulation framework has received positive feedback for its contribution to address the regulatory issues, it has also faced criticism for being seen as "co-regulation in appearance only without any real differentiation from existing self-regulation." This study aims to examine the case of industry-specific co-regulation proposed by the Personal Information Protection Commission, with the objectives of 1) determining whether their approach can be categorized as a type of co-regulation with differentiation from the existing self-regulation programs, and 2) proposing improvements for successful regulation. The 'co-regulation' of the Commission can be classified as a form of co-regulation that differs with traditional self-regulation, as it involves government and private organizations collaborating to establish self regulatory codes reflecting industry-specific characteristics as well as provides interest groups with incentives to comply with the codes. The co-regulation framework is evaluated to some extent as successful, but there is still room for improvement in three major aspects. (1) When selecting the areas for co-regulation, a focus should be placed on areas where technological changes are rapid, and government regulations should be applied in areas where they are not. (2) It is necessary to enhance the expertise of regulatory agencies, and (3) ensuring the democratic nature of regulation, such as encouraging the participation of civil organizations, is necessary.

• 약학회지
• /
• 제52권2호
• /
• pp.151-159
• /
• 2008

Consultation program for pharmaceutical development is a new system in which pharmaceutical companies meet and discuss scientific and/or regulatory issues with drug regulatory authority in the research process and before submitting new drug applications. This program helps pharmaceutical companies reduce uncertainties in the research and development and increase the possibilities of getting drug marketing approval. Developed countries such as US, EU, and Japan have implemented various forms of pre-submission meetings or consultation programs since the mid-1990s. The rapid development of technology in pharmaceutical R&D increases the importance of communication between drug development companies and drug regulatory authority in Korea, too. In designing the consultation program, it is desirable to focus on the stages of clinical trials which take the longest period of time and the biggest amount of money in the pharmaceutical R&D process. We suggested that results or recommendations by drug regulatory authorities in pre-submission meetings or consultations be formally documented and considered in review process. Explicit scientific reasons are required for changing the results from consultations.

• 한국동물생명공학회지
• /
• 제38권4호
• /
• pp.247-253
• /
• 2023

Revolutionary advancements, such as the reduction in DNA sequencing costs and genome editing, have transformed biotechnology, fostering progress in manipulating biomolecules, engineering cells, and computational biology. Agriculture and food production have significantly benefited from tools like high-throughput microarrays, accelerating the selection of desired traits. Genetic engineering, especially utilizing genome editing, facilitates precise alterations in plants and animals, harnessing microbiomes and fostering lab-grown meat production to alleviate environmental pressures. The emergence of new biotechnologies, notably genome editing, underscores the necessity for regulatory frameworks governing LM (living modified) organisms. Global regulations overseeing genetically engineered or genome-edited (GE) organisms, encompassing animals, exhibit considerable diversity. Nonetheless, prevailing international regulatory trends typically exclude genomeedited plants and animals, employing novel biotechnological techniques, from GMO/ LMO classification if they lack foreign genes and originate through natural mutations or traditional breeding programs. This comprehensive review scrutinizes ongoing risk and safety assessment cases, such as genome-edited beef cattle and fish in the USA and Japan. Furthermore, it investigates the limitations of existing regulations related to genome editing in Korea and evaluates newly proposed legislation, offering insights into the future trajectory of regulatory frameworks.