• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.91-124
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• 2021

In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

• The Korean Journal of Archival Studies
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• no.22
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• pp.115-155
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• 2009

As Korea was merged into Japan, the official documents during Kabo Reform and The Great Han Empire time were handed over to the Government-General of Chosun and reclassified from section based to ministry based. However they had been reclassified before many times. The footprints of reclassification can be found in the classification stamps and warehouse number stamps which remained on the cover of official documents from Kabo Reform to The Great Han Empire. They classified the documents by Section in the classification system of Ministry-Department-Section, stamped and numbered them. It is consistent with the official document classification system in The Great Han Empire, which shows the section based classification was maintained. Although they stamped by Section and numbered the documents, there were differences in sub classification system by Section. In the documents of Land Tax Section, many institutions can be found. The documents of the same year can be found in different group and documents of similar characteristics are classified in the same group. Customs Section and Other Tax Section seemed to number their documents according to the year of documents. However the year and the order of 'i-ro-ha(イロハ) song' does not match. From Kabo Reform to The Great Han Empire the documents were grouped by Section. However they did not have classification rules for the sub units of Section. Therefore, it is not clear if the document grouping of classification stamps can be understood as the original order of official document classification system of The Great Han Empire. However, given the grouping method reflects the document classification system, the sub section classification system of the Great Han Empire can be inferred through the grouping method. In this inference, it is understood that the classification system was divided into two such as 'Section - Counterpart Institution' and 'Section - Document Issuance Year'. The Government-General of Chosun took over the official documents of The Great Han Empire, stored them in the warehouse and marked them with Warehouse Number Stamps. Warehouse Number Stamp contained the Institution that grouped those documents and the documents were stored by warehouse. Although most of the documents on the shelves in each warehouse were arranged by classification stamp number, some of them were mixed and the order of shelves and that of documents did not match. Although they arranged the documents on the shelves and gave the symbols in the order of 'i-ro-ha(イロハ) song', these symbols were not given by the order of number. During the storage of the documents by the Government-General of Chosun, the classification system according to the classification stamps was affected. One characteristic that can be found in warehouse number stamps is that the preservation period on each document group lost the meaning. The preservation period id decided according to the historical and administrative value. However, the warehouse number stamps did not distinguish the documents according to the preservation period and put the documents with different preservation period on one shelf. As Japan merged Korea, The Great Han Empire did not consider the official documents of the Great Han Empire as administrative documents that should be disposed some time later. It considered them as materials to review the old which is necessary for the colonial governance. As the meaning of the documents has been changed from general administrative documents to the materials that they would need to govern the colony, they dealt with all the official documents of The Great Han Empire as the same object regardless of preservation period. The Government-General of Chosun destroyed the classification system of the Great Han Empire which was based on Section and the functions in the Section by reclassifying them according to Ministry when they reclassified the official documents during Kobo Reform and the Great Han Empire in order to utilize them to govern the colony.

• The Korean Journal of Ecology
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• v.4 no.3_4
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• pp.68-79
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• 1981

We discovered following on our surveys to the island six times in May, August (1978), in April, May, June, July (1979). There are 73 families, 158 genera, 189 species, 31 varieties over Tracheophyta Fuller & Tippo. Till early or middle age of Lee Dynasty, the island's dominant plants was evergreen broad-leaved trees, mainly consisted with Camellia japonica L. and Castanopsis cuspidata Schot, var. sieboldii Nakai but due to the population growth and increased exiles constant ground burnt off fr cultivation, the number of evergreen broad-leaved trees was decreased and that of P. densiflora S. et Z. replaced position. That is to say, the island was dominated by the flora of the subtropical zone era, but it has been complicated by flora of the temperate zone whose reproductivity is more vivid, in modern era. Recently Pinus thunbergiana Franco, Robinia pseudo-acasasia L. Amoroha fructicasia L. invaded and reserved inthe island. During a decade of the end of Japanes rule and after liberation about all of Pinus densiflora S. et Z. were cut downed, and after that, under the Forest Bureau, there have being sucessed to Pinus thunbergiana France. Camellia japonica L. other 20 species of evergreen broad-leaved trees are distributed in Island Wi, a tutelary shrine of Dae Ri, a mountain at the back of a village of Chi Do Ri and a mountain at the back of Jin Ri administrative office of a township. The special plants of the island are 1) state of Lycoris aurea Herb which of foun in a ridge between fields and forest around Jin Ri and 2) stock of Cmbidium virescens Lindly bloomed under the Pinus densiflora forest of Keun Tan Chi Do.

• Journal of the Korean BIBLIA Society for library and Information Science
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• v.29 no.2
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• pp.169-197
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• 2018

The research aims to analyze current university information disclosure services in the perspectives of both university records management and services and to recommend ways to improve the current university information disclosure systems and services. The research collects and analyzes various raw data such as laws, guidelines, and manuals of university information disclosure services and the portal site of 'Higher Education in Korea' also known as 'dae-hak-al-ri-mi', and data on each homepage of 40 cooperative universities selected as the research sample. At the result, the research found some limits in the current operation of university information disclosure services: first, the information posted on the university disclosure information system is mostly focused on administrative information rather than information related to research or education within universities. Second, there are the high rate of error and frequent modification in the information posted on the disclosure information system. Third, the menus on both the information disclosure system and homepages of each cooperative university are useless or contents of the menus are empty. The research suggests some solutions to improve these problems: it is required to make up the current legal systems for university information disclosure services and to cooperate all organizations and universities related to university information disclosure services within the united system and rule. Also, it is crucial to attach the metadata of the disclosed information when to post the information to the university disclosure information systems. Finally, it is necessary for each university to employ archivists not only to develop qualified university records to maintain the unique roles and value of universities but also to disclose reliable and authentic information to users and manage the university information disclosure systems effectively and efficiently.

• Journal of Information Technology Services
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• v.13 no.3
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• pp.149-164
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• 2014

The laws and policies governing Korea's game regulations are becoming more and more topics for debate as we enter the Age of Internet. The nature of the basis for Internet regulations and policies are not rooted in freedom of speech or fundamental values of democracy, but rather focused on solving real-world problems such as protection of the youth. Furthermore, the reality is that regulatory devices for keeping the social order such as regulating gambling are being applied directly to games without consideration on the characteristics of Internet gaming, raising concerns that the expansion of constitutional values and innovative empowerment inherent to the Internet are being weakened. The Geun-Hye Park Administration which succeeded Myung-Bak Lee's Administration, even went so far as to implement the so-called "Shutdown Policy", which prohibits access to Internet games during pre-defined time zones and also instigated a time zone selection rule. In order to curb the gambling nature of Internet games, government-led policies such as the mandatory personal identification and prohibition of player selection or in other words mandatory random player selection are being implemented. These institutions can inhibit freedom of speech, which is the basis of democracy, violate the right of equality through unreasonable discrimination between domestic and foreign service providers, and infringe upon the principles of administrative law, such as laws, due process in policies, and balance in among policies and governmental bodies. Going forward, if Korea's Internet game regulations and polices is to develop in a rational manner, regulatory frameworks will need to be designed to protect the nature of the Internet and its innovative values that enable the realization of constitutional values; for example, the Internet acting as the "catalytic media for freedom of expression as a fundamental human right ", which has already been acknowledged by the Korea's Constitutional Court. At the same time, transparent procedures should be put into place that will allow diverse participation of stakeholders including game service providers, game users, the youth and parents in the legislation and enforcement process of regulatory institutions; policies will also need to be transformed to enable not only regulatory laws but also self-regulation system to be established. And in this process, scientific and empirical analysis on the expected effects before introducing regulations and the results of enforcing regulations after being introduced will need to be strengthened.

• Journal of Korean Society of Transportation
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• v.25 no.5
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• pp.15-21
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• 2007

This paper proposes an improved methodology for estimating traffic accident cost savings in the transport appraisal. Four major problems from the existing framework are identified and their alternatives are suggested. First, casualties in the established approach are classified by just two types of 'killed' and 'injured'. This study supplies the indices of fatality further details. Namely, road victims are regrouped by 'killed', 'seriously injured', 'slightly injured', and 'accident reports'. Those of railways are similarly sorted by 'killed', 'seriously injured', and 'slightly injured'. Second, damage only accidents are not satisfactorily considered in the current arrangement. The accidents should be considered as one of the accident types and the social cost of them should also be evaluated. Third, the unit cost of accidents is given by the total value. The unit cost is consisted of several elements and each loss would be useful for a policy frame. This study breaks down the total figure into four pieces of costs, namely production loss, medical treatment, property loss, and administrative costs. Finally, there is inconsistency in the audit between roads and railways. Road accidents are analyzed by road types. On the other hand, patronage or others is the classification rule of rail accident costs. This paper suggests a way that the accident costs of two modes can be coherently estimated based on the level of services by each mode. The result of this study is expected to help frame more cautious social overhead capital investment policies.

• Journal of the Korean Society of Marine Environment & Safety
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• v.3 no.1
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• pp.51-71
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• 1997

As passenger ship accidents so frequently have occurred, crisis consciousness is highly aroused in Korean society. Although bombastic policy guidlines were suggested in accordance with every passenger ship accident, there remains a still high possibility of such an accident reoccurring because passenger ship accidents occur from the perspective of non-compliance. The research objective of this study is to government's safety regulatory policies. Data for the analysis was collected from literature review. A Case study related to passenger ship accident is adopted for the analysis. The research methods utilized in this study consist of extensive quantitative analysis of 138 passenger ship accidents which had happened over last 10 years from 1984 to 1993 in Korea and a qualitative analysis of the passenger ship accident of the Seohae Ferry in October 1993. The results of the quantitive analysis on the 138 passenger ship accidents are as follows; Seeing the accidents yearly, the accidents which occurred by policy non-compliance are still exist, only somewhat reduced as years gone by. Seeing the accidents from the perspective of types of accident, fire accidents and death and injury accidents had more non-compliance factors than contact accidents and one-side collision accidents, etc. had. Seeing the accidents from the perspectives of types of passenger ship, large ships like car ferries and general passenger ship accidents had more non-compliance factors than any other kinds of ships had. Seeing the accidents from the perspectives of tons of passenger ships, large ships weighing more than 1, 000 tons and small ships weighing less than 50tons contained a lots of non-compliance factors. The results of the qualitative analysis of the passenger ship accident of the Seohae Ferry in Octovber 1993 are as follows; From the viewpoint of the human factor, there were non-compliance to the recruiting of required number of qualified crew members and non-compliance to the rule which prohibited them from leaving port in bad weather and high wave conditions. From the viewpoint of the ship factor, there were defects in the ship. So we might say that there was non-compliance which was aroused from the lacks of technical skills. From the viewpoint of the administrative factor, there were many non-compliance factors such as sailor education, shipping management, rescue, safety equipment. From the viewpoint of the passenger factor, there were passengers' threats which compelled the crews to leave the port under bad weather conditions. In conclusion, the principal non-compliances factors are passenger ship company did not follow safety rules such as shipping the permitted number of passengers, loading permitted tons of freight and fastening freights properly and recruiting required number of qualified crew. In order to reduce accidents, firstly we should find out the causes which play key roles in passenger ship companies' non-compliance to the government's safety regulations. Secondly we should tackle the causes.

• International Commerce and Information Review
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• v.14 no.4
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• pp.387-408
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• 2012

This paper have examined the descriptive and legal approaches to the comparison and analysis of major content of direct transport in FTA rules of origin and the primary judicial precedents that arose during the executing process of FTAs. Preferential tariff treatment shall be applied to a good satisfying the requirement of this agreement(annex, article etc.,) and which is transported directly between the territories of the exporting party and importing party. However, products may be transported through territories of non-parties, provided that they do not undergo operations other than unloading, reloading, splitting-up of consignments or any operation designed to preserve them in good condition. During this period the products shall remain under customs control in the country of transit. The low perception of firms on the rules of origin was found to lead to breaking the rule and thus taking up losses. The FTA major countries enacted penalty rules against the violation of the rules of origin and bring civil and criminal suits and administrative sanctions. The types and level of penalties are subject to their domestic laws of each of those nations. With better recognition of major content of direct transport in FTA rules of origin and well-prepared countermeasures, firms will be able to enhance competitive advantage while benefiting from preferential tariffs.

• Journal of Digital Convergence
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• v.13 no.1
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• pp.353-366
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• 2015

The purpose of this study was to examine how region-specific characteristics affect the occurrence of cardiac arrest. To analyze, we combined a unique data set including key indicators of health condition and cardiac arrest occurrence at the 244 small administrative districts. Our data came from two main sources in Korea Center For Disease Control and Prevention (KCDC): 2010 Out-of-Hospital Cardiac Arrest Surveillance and Community Health Survey. We analyzed data by using multiple regression, geographically weighted regression and decision tree. Decision tree model is selected as the final model to explain regional variations of cardiac arrest. Factors of regional variations of cardiac arrest occurrence are population density, diagnosis rates of hypertension, stress level, participating screening level, high drinking rate, and smoking rate. Taken as a whole, accounting for geographical variations of health conditions, health behaviors and other socioeconomic factors are important when regionally customized health policy is implemented to decrease the cardiac arrest occurrence.

• The Korean Journal of Archival Studies
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• no.51
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• pp.235-278
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• 2017

Then, why was the system so thorough and strict? How could that be possible? I approached this question by explaining the task of the Joseon Dynasty for the construction of a Confucian community based on Sunglihak. Sunglihak meant the metaphysics of human nature and universe order, or the rule of heaven. The people who opened the Joseon Dynasty aimed at constructing a Confucian community based on propriety as the principle of the society. The records and archives played an administrative function, for example, controlling royal power, as well as the role of constructing a national community identity based on Sunglihak. This kind of records and records management practices of the Joseon Dynasty can be seen as conceptual construction and conceptual constructs, although they were physical entities in reality. They reflected the Sunglihak value system as, in the words of Michel Focault, an "episteme" and played a social role based on it. In particular, I explained it in light of the constructivism of Sunglihak and the semiosis concept of Charles Sanders Peirce.