• Journal of Pharmaceutical Investigation
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• 제36권6호
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• pp.421-435
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• 2006

The objective of this report is to introduce the European Union's variation rules governing medicinal products that are subject to post-approval changes. The EMEA outlines a variety of changes occurring to approved medicinal products. It also recommends a marketing authorisation holder to follow specific post-approval applications in various situations. For instance, the Commission Regulation(EC) No. 1085/2003 explains variation types and suggests post-authorisation procedures with which an applicant should comply. In all cases of minor and major variations the applicant has to investigate and validate whether or not the intended changes would have impact on the safety, efficacy and quality of a drug product. The applicant should then submit to the EMEA a variation application with adequate documentation in support of the notified changes. This procedure is implemented to ensure that changes to the approved medicinal product do not cause my public health concerns. In fact, the post-authorisation guidance categorizes post-approval changes into type IA/IB variations, type II variations, and extension applications. Such classifications determine administrative procedures to be followed in an efficient manner. Based on the type of a variation, the regulatory agency opts to reduce or extend the evaluation time-frame. The thrust of the EU's post-authorisation guidance is introduced in text with appropriate explanation. All these information will be likely to be helpful in updating a Korean regulatory guidance that could better deal with post-approval changes to generic drugs available in the market.

• Proceedings of the Korea Contents Association Conference
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• 한국콘텐츠학회 2007년도 추계 종합학술대회 논문집
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• pp.799-803
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• 2007

In this paper, we research into an effective operation environment of digital textbook according to the adaption of an electronic textbook and analyze the approval program and the authorization program of the paper textbook for the efficient utility of a digital textbook. We propose various criterions and methods of the approval and authorization program. Finally, we show the whole process of the proposed approval and authorization program. We hope that our study apply to the standard approval and authorization program of the Ministry of Education.

• Journal of the Korea Convergence Society
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• 제11권1호
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• pp.237-246
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• 2020

The background of the research is the following: As a result of ultra-light flying device industry development, the utilization of drones and their efficiency have been increasing. However, problems regarding flight permission·approval procedure have not been improved, resulting in increased number of civil complaints. Thus, the purpose of this research is to minimize such civil petition according to the required standards of the two government organizations through enhancing the procedure for managing and employing the system. The research methods entail pinpointing the problems by analysing ultra-light flying device related literature review and by holding focus-interviews with field experts, thereby verifying and providing improved solutions. Under (MLIT) Ministry of Land, Infrastructure and Transport supervision and in accordance with aviation security law, the research provides various updated functions such as improved civil petition processing system's employment and management system, flight approval, integration of names, process, format regarding aviation photographing approval, tool buttons such as the 'Main' button in the system's homepage. This research has the following expected effects : Firstly in the law and regulations section, the clear distinction in the missions and roles of each organization enhances cooperations in tackling civil petition. Secondly the integration of civil petition process reduces time and improves efficiency. And lastly, the improvement of supplementary tools for the public is expected to minimize civil petitions. Future research needs to be conducted under the supervision of the Ministry of National Defense(MND). Factors such as systematic infrastructure for flight photography approval, related unit's reorganization following the defense reform 2.0, and guaranteed conditions for field security action units need to be ameliorated.

• Korean Journal of Clinical Pharmacy
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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.

• Proceedings of the Korean Nuclear Society Conference
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• 한국원자력학회 2002년도 춘계공동학술발표회요약집
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• pp.355.2-355
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• 2002

• Journal of Advanced Navigation Technology
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• 제27권5호
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• pp.621-628
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• 2023

This study derived a reverse engineering procedure for verifying the design identity of original parts and developed parts for PMA(Parts Manufacturer Approval) and STC(Supplemental Type Certificate) of metal brake pads for transport aircraft, which are critical parts among aircraft parts and equipment. In Korea, the regulations for reverse engineering procedures are regulated by the Parts Manufacturer Approval Guidelines, and in the United States, AC No. 21. 303-4. In the reverse engineering for the brake pad, the detailed procedures for each component were determined by selecting verification test items to confirm identity based on sample quantity, dimensional tolerance, mechanical property measurement, material, weight and volume characteristics for each component. In addition, as a result of analyzing the regulation of Korea and United States, in the case of Korea, it is necessary to establish technical standards for braking systems for transport aircraft and regulations related to flight tests.

• The Journal of the Korea institute of electronic communication sciences
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• 제17권5호
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• pp.745-758
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• 2022

As the unlimited natural source of a country, radio waves are widely being used in the daily life toward knowledge based information society. Therefore it is necessary to provide a long term policy of radio waves management policies based on market situation to cope with rapidly changing wireless technology and effective use of radio resources. Literary survey and analysis were accomplished for the rules and regulations in the radio station approval system and post-approval policies for mobile communication service. In conclusion, this study propose an blanket radio approval policy as well as self declaration of conformity(SDoC) of radio waves technical regulation and advanced radio inspection procedure. This study has significance in providing reference for introducing deregulation policy in the radio communication imdustry.

• Journal of Advanced Navigation Technology
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• 제17권6호
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• pp.625-632
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• 2013

Since GBAS is a navaid facility to provide precision approach service to aircrafts landing at airports, it must be approved by the air navigation service provider or the aviation regulator to be declared operational. However, Korea has no experience in developing or operating the system so there is no approval criteria for GBAS. In order to develop the criteria in case of the future GBAS procurement, Korea Aerospace Research Institute has been testing the installed commercial GBAS station, SLS-4000, in Gimpo International Airport. This paper summarizes the criteria development results focusing on the system design approval. The criteria have been outlined based on the other leading nations' cases and documentations and established in detail on the basis of the FAA SDA artifacts. Those will be directly used for GBAS approval procedure in Korea and are expected to be useful in system requirement analysis, design, development and artifact management in case of own GNSS-based navaid system development in the future.

• Proceedings of the KSR Conference
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• 한국철도학회 2005년도 추계학술대회 논문집
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• pp.125-130
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• 2005

The railway shall be verified with the view point of dynamic performances before delivering to the Customer and the verification procedure shall be followed the Customer's demands or relevant international standard, UIC 518 (Testing and approval of railway vehicles from the point of view of their dynamic behavior-Safety-Track fatigue-Ride quality). In this paper, verification procedures in UIC 518 and the test results for domestic project are summarized.

• Journal of the Korean Society of Marine Environment & Safety
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• 제26권3호
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• pp.286-296
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• 2020

Sandwich structures are general-purpose structures that can reduce the structural weight of composite ships. Core materials are essential for these structures, with polyvinyl chloride (PVC) foams being the most popular. These foam core materials are subjected to various tests in the development process, and must satisfy the performance requirements of several ISO and ASTM standards. Therefore, a procedure for evaluating the performance of foam core materials was proposed in this paper. In addition, prototypes were fabricated using a commercial PVC foam core product in accordance with the structural design of an 11 m fiber-reinforced plastic yacht. Then, a case study was conducted on the proposed evaluation procedure. The proposed procedure facilitates the understanding of the performance requirements and evaluation of core materials used in composite ships and is expected to be utilized in developing core materials for marine structures.