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The Study of Comparative Legal Review According to Data Exclusivity of Pharmaceutical Marketing Authorization - In preparation for the development of drugs and vaccine of COVID-19 - (의약품 자료독점권(Data Exclusivity)에 대한 비교법적 고찰 - COVID-19 치료제 및 백신 개발을 대비하여 -)

  • Park, Jeehye
    • The Korean Society of Law and Medicine
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    • v.21 no.1
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    • pp.223-259
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    • 2020
  • With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

Effect of Defatted Soy flour on the Bread Making Properties of Wheat flour (탈지 대두분 첨가가 제빵 특성에 미치는 영향)

  • Yoo Yang-Ja;Chang Hak-Gil;Choi Young-Sim
    • Korean journal of food and cookery science
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    • v.21 no.3 s.87
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    • pp.301-310
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    • 2005
  • The effects of defatted soy flour on the physicochemical characteristics of dough and bread making properties were studied. Defatted soy flour is added to wheat flour for bread-making in order to maximize the use of isoflavones in the soybean. Different particle sizes of both defatted soy flour and wheat flour were prepared by grinding and sievingwith meshes. In the mixograph test, the addition of defatted soy flour to wheat flour increased the requirement for water and decreased the dough development time. Water absorption rates were also investigated to determine the optimum quantity of water for good dough. As the level of defatted soy flour mixed with wheat flour increased, the sedimentation and P.K. values decreased. In comparison with control, the bread made with defatted soy flour especially had a lower specific loaf volume. Specific loaf volume of wheat flour-defatted soy flour bread prepared (Ed- this is an incomplete sentence, it's only a subject clause, and I don't how what you intend to state). In terms of the staling rate and hardness of the wheat flour-defatted soy flour bread, the increased defatted soy flour had a faster staling rate during storage at 5? than at 25? for 5days. From the result of sensory evaluation, wheat flour-defatted soy flour breads containing up to $4\%$ defatted soy flour were rated as being of high quality.

A Study on the Record Management of National Archives of Korea (국가기록물 관리의 현황에 관한 발전적 제언)

  • Kim, Sung-Soo
    • Journal of Korean Society of Archives and Records Management
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    • v.3 no.1
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    • pp.159-184
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    • 2003
  • In this research the issues of record management of national archives in Korea are classified into four categories: 1) improving the status of the Central Archives of Korea, 2) constructing a new national archives, 3) revising the law on the record management, 4) creating qualifications for a professional administrator for Archivist. 1) In order to strengthen the function of the Central Archives of Korea, it is very urgent to create a systematic mechanism in which the Central Archives oversees and administers public archives(documents) collected from all the public institutions not only under the Administration but also the legislature and the judicial authorities. 2) This paper suggests that a new National Archives should be a symbolic building representing Korea as archives. Considering the fact that Presidents archives will be a part of this new National Archives, it also suggests that artistic and decorative pieces which embody Korea's representative archives or people should be included in the building. The budget for these should be supplied by the government. 3) This paper looks at the matter of revising the law on Record Management in two respects: (1)strengthening the function of the Central Archives of Korea, (2)making it obligatory to produce archives not open to the public, or making a protection clause for secret archives. This paper proposes that the Central Archives of Korea will be able to collect all the public archives from all the public institutions, and to oversee and administer them by revising the 5th and 6th clauses of the current law on the record management. It also proposes that some laws which make it obligatory to produce archives for documents not open to the public, and which protect those secrecy. 4) Regarding the qualifications for a professional administrator for the record management, this paper suggests lowering the qualification a little to the bachelor's degree of the record management. Also it suggests taking into consideration the persons in charge of the record management in public institutions and acknowledging their qualifications after a certain period of training at the Central Archives of Korea or something like that. In addition, it classifies the ranks of the professional administrators according to their qualifications.

A Study on the Efficiency of the North Korean Foreign Economy Arbitration Law (북한 대외경제중재법의 실효성 고찰)

  • Kim, Suk-Chul
    • Journal of Arbitration Studies
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    • v.18 no.1
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    • pp.167-184
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    • 2008
  • The economic cooperation between the South and North Koreas is a very important issue for the unification and economic development of both Koreas. In order to reach a successful economic cooperation, there is a need to coordinate the differences of the two countries before unification. The economic cooperation and the cooperation in other sectors will be followed by the entire unification. It is necessary to prepare a mechanism that could peacefully solve the conflicts and disputes that could arise during the actual process of cooperation, which will secure stable investments and trades. The study on the possibility of introducing the arbitration system as a conflict solving mechanism between the two Koreas is a very important subject, and the basis of this study is on the examination of the arbitration laws of North Korea. Therefore, the study on the efficiency of the North Korean arbitration laws on foreign economy is studying the possibility of a systematical solution to economic conflicts between the South and North Koreas. The problems and possible solutions of the North Korean foreign economy arbitration laws are summarized as follows. First, juridical cooperation system for both South and North courts of justice needs to be set up to smoothly carry out the main procedures. Mutual correspondence and telecommunication needs to be guaranteed, also remittance and the movement of goods shall precede. Second, the free liquidation of businesses by unit and the individual and independent management of wealth of the North Korean economic bodies, organizations and businesses shall precede to independently liquidate wealth and thus make arbitration possible. Third, amendments in the North Korea's foreign economy arbitration law shall be made to some parts of regulations on arbitration agreements and specific contents of written arbitration agreements to avoid conflicts regarding arbitration agreement. Fourth, the members of the North Korean arbitration committee shall impartially manage the committee only without taking the role of arbitrator, and the clause that allows the North Korean committee to nominate the arbitrator shall be erased. In case an agreement regarding the number of arbitrators is not reached, the three arbitrators general rule shall be applied. In case of requests from any of the parties, a third country arbitrator nomination shall be guaranteed. Also, the requested arbitrator by the party shall be nominated with the cooperation of the court. Fifth, the trial in case of non-appearance or written trial shall be added to the North Korean law in to prevent intended negligence or evasion. Sixth, regulations regarding the court's investigation of evidence shall be added to the North Korean law to make fair arbitration possible in case that government power is needed in order to investigate evidence. Seventh, provisions regarding majority decision shall be added in the North Korean law in the impossibility of unanimous decisions, and the certified system in the arbitration committee official text shall be erased to prevent arrogation and assure the power of the decision made by the arbitration government. Eighth, as "the wrong decision approved" reason for cancellation of arbitration in the North Korean law includes the content of the decision made by the arbitrator could lead to uselessness of arbitration, amendment will be necessary to limit it to legitimacy of the arbitration agreement and wrong procedures. It is hoped that this thesis will be of important use in understanding the issues on the workability and the solutions to the South and North Koreas' arbitration that could be presented during the negotiations for the countries' economic cooperation.

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A Study on the Legal Aspects of International Express Courier Business (현행 항공법상 상업서류 송달업의 문제점과 입법방향)

  • Lee, Chang-Jae
    • The Korean Journal of Air & Space Law and Policy
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    • v.26 no.2
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    • pp.125-147
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    • 2011
  • Considering a trend of logistics and transport industry in these days, it can be said that international express courier service is one of the most familiar transport type to the general public. Especially in Korea, due to development of electronic commercial transaction and the popularity of television home shopping, it can easily anticipated that express courier business will continuously grown in the future. However, the legal basis for international express courier is not properly set up so far. The only clause about this can be found on Korean Aviation Law said as 'commercial documents delivery business'. The origin of the commercial documents delivery business in Aviation Law is to make exception from public postal services which has been exclusive status as monopoly based on the Korean Postal Law. Basically, according to this regulation, all the private postal delivery is prohibited except some sort of commercial documents such as consignment notes, packing list, invoice etc. Thus, those documents could be delivered not only by public postal services but also by private courier company according to the Korean Postal Law. This waiver has probably come from under developing condition of Korean postal circumstances, however it should be revised according to the modernized business practice. Reflecting these revisions, the articles of Korean Postal Law adopted 'international express courier document' as the exception of postal service. Therefore, Korean Aviation Law also needs to be revised as Postal Law in due course. In addition to revision of Korean Aviation Law, some sort of new legislation is required to govern the private legal aspects such as legal liabilities, duties and rights of each parties on international express courier. This should be governed by 'law' not by 'terms and conditions' provided by business operators. Furthermore, to support and develop the current domestic logistics companies as international express courier company, it is required to regulate with the separate express courier law.

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The Design and Application of Vibrator Type(AM) Combination Apparatus for Improving Police Equipment for Fugitive Prevention (도주방지용 경찰장구의 기능개선을 위한 진동자 방식(AM) 결속장치 설계 및 응용)

  • Choi, Ki-Nam;Lee, Seon-Jeh
    • Convergence Security Journal
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    • v.11 no.2
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    • pp.13-24
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    • 2011
  • Policemen judge the situations rationally and use their equipment such as handcuffs and rope within the purview, finding them needed to arrest criminals in the act who commit crimes which conforms to death penalty, life imprisonment or long imprisonment for over 3 years in accordance with Clause 10-2, Article 1 of the Police Mandate Law and prevent fleeing from them, defend their and others' lives and bodies, or if there are probable causes to be recognized that using equipment is necessary to restrain the interference with government officials in the execution of their duties. However, as the cases which the criminals run away in handcuffs or with both hands tied occur, it results in the waste of police force, distrust and enormous trouble in the pursuit of their duties. Therefore, if the way to perceive fleeing of criminals who have already worn the police equipment by some simple assistive devices without developing other new equipment, it will be very effective for police duties. This study is about the combination apparatus for fugitive prevention attached to the existing handcuffs and rope whose alert sounds let the staffs working inside the office perceive the fleeing of wanted criminals and examined suspects who wear the handcuffs or are tied up with rope, providing that they go through the exit where a transmitter and a receiver were set. The combination apparatus for fugitive prevention which the study introduces contains the connecting parts which connect a flexible tube(cognition tags inside of the tube) of connector equipped with the police equipment with the ends of the tube and the part where these two meet and which connect them inside of the tube. The connecting parts are easy to be attached to the police equipment such as handcuffs and rope, but hard to be dismantled by the people tied up with the equipment. It enables watchers to perceive the fleeing of wanted criminals and examined suspects who wear the handcuffs or are tied up with rope, providing that they go through the exit where a transmitter and a receiver were set. Plus, if it is combined together with the portable receiver, it can be installed on the patrol cars and easily adopted to supervise illegally accessing of evidences. It is also avaliable to be adjunctively utilized for the handcuffs provided and the cost is so reasonable. Owing to its snap-on way to the cuffs, it can clear up any invasion of privacy and it can not be used as a self-injury tool because of the soft tube. Using AM Tag minimizes the lack of malfunction.

Improvement Strategy & Current Bidding Situation on Apartment Management of Landscape Architecture (공동주택 조경관리 입찰 실태와 개선방안)

  • Hong, Jong-Hyun;Park, Hyun-Bin;Yoon, Jong-Myeone;Kim, Dong-Pil
    • Journal of the Korean Institute of Landscape Architecture
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    • v.48 no.4
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    • pp.41-54
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    • 2020
  • This study was conducted to provide basic data for a transparent and fair bidding system by identifying problems and suggesting improvement measures through an analysis of the bidding status for construction projects and service-related landscaping of multi-family housing. To this end, we used the data from the "Multi-Family Housing Management Information System (K-apt)" that provides the history of apartment maintenance, bidding information, and the electronic bidding system to examine the winning bid status and amount, along with the size and trends of the winning bids by year, and the results of the selection of operators by construction type. As a result, it was found that out of the total number of successful bids (36,831), 4.4% (16,631) were in the landscaping business, and the average winning bid value was found to be about 24 million won. According to the data, 73% of the landscaping cases were valued between 3 million won and 30 million won, and 58.6% of the cases were in the field of "pest prevention and maintenance". 36% of the total number of bids were awarded from February to April, with "general competitive bidding" accounting for 59.8% of the bidding methods. As for the method of selecting the winning bidder, 55% adopted the "lowest bid" and "electronic bidding method," and 45% adopted the "qualification screening system" and "direct bidding method." As an improvement to the problems derived from the bidding status data, the following are recommended: First, the exception clause to the current 'electronic bidding method' application regulations must be minimized to activate the electronic bidding method so that a fair bidding system can be operated. Second, landscaping management standards for green area environmental quality of multi-family housing must be prepared. Third, the provisions for preparing design books, such as detailed statements and drawings before the bidding announcement, and calculating the basic amount shall be prepared so that fair bidding can be made by specifying the details of the project concretely and objectively must be made. Fourth, for various bidding conditions in the 'business operator selection guidelines', detailed guidelines for each condition, not the selection, need to be prepared to maintain fairness and consistency. These measures are believed to beuseful in the fair selection of landscaping operators for multi-family housing projects and to prepare objective and reasonable standards for the maintenance of landscaping facilities and a green environment.

A Study on the Correspondence and the Autonomy between the Act on the Guarantee of Rights of and Support for Persons with Developmental Disabilities and the Similar Ordinances of the Local Governments (발달장애인 권리보장 및 지원에 관한 법률과 지방자치단체 유사조례 간의 연계성과 자치성에 관한 연구)

  • Jeon, Jihye;Lee, Sehee
    • 한국사회정책
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    • v.25 no.2
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    • pp.367-402
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    • 2018
  • This study analyzed the relationship between the act on the guarantee of rights of and support for persons with developmental disabilities(Act for PWDD) and the similar ordinance of the local governments based on this law and focused on the correspondence(the rate of reflection) and the autonomy(differentiation). As of October 2017, 63 local government regulations and Act for PWDD were analyzed in this study. The results of the analysis are as follows: First, the rate of reflection in the ordinance of Act for PWDD was different according to the clause. In the aspect of emphasizing welfare support, the agreement between local ordinance and rate was high. While the Act for PWDD emphasized the rights of persons with developmental disabilities, there was little information about their right in the ordinance of local governments. This is evidence that current ordinance is based on the protective point of view for people with developmental disabilities. In the future, policy measures will be needed to ensure that respect for decision-making by persons with developmental disabilities and rights guarantees are included in the bylaws. Second, there is a provision that the rate of ordinance reflection is 0%, which may be guaranteed by other laws in the area, so it does not mean the absence of related system in the region, but there is possibility of institutional blind spot. In the future, consideration should be given to the complementarity of other legal systems in the area with developmental disabilities, so that persons with developmental disabilities should not be placed in institutional blind spots. Third, the autonomy(differentiation) of local ordinance was examined from the contents aspect and the administrative aspect to help practical implementation. The differentiation between the ordinances vary. Emphasizing the responsibilities of the head of the organization, emphasizing the fact-finding survey, setting up the welfare committee, or adding local needs were included to the ordinance. Local governments considering the enactment of ordinances in the future should refer to these cases and establish enactable local ordinances that take advantage of the characteristics of local autonomy.

Study on Improvement of Family Assistance System for Victim's Family of Air Traffic Accident (항공사고 피해자 가족지원 제도개선 연구)

  • Jeon, Jong-Jin;Kim, Hui-yang;Yoo, Kwang-Eui
    • The Korean Journal of Air & Space Law and Policy
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    • v.33 no.2
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    • pp.315-343
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    • 2018
  • In the event of an air accident, the media and members of the general public pay attention to the victim of the accident and are deeply concerned about their actions and rewards. However, through the accident of Air China(CCA) Flight 129, which occurred in 2002, we were able to confirm that it is a real problem that the victims of the air accident as well as the victims suffer much suffering and serious aftermath. Nevertheless, Korea's system for assistance the families of victims of air accident is very poor. On the other hand, when Trans-World Airlines(TWA) Flight 800 exploded and crashed over the Atlantic Ocean in 1996, the United States enacted a law to assistance the families of the victims of the accident. According to this law, systematic assistance and management of not only the victims of the accident but also their families, minimize the additional damage of victims and victims' families and help them to get rid of the accident after the accident. In particular, the measures taken by the US authorities in response to an accident in which an Asiana Airlines flight(AAR) 214 crashed during a landing at San Francisco International Airport in 2013, made a lot of suggestions for us to assistance the victims and their families in an air accident. The purpose of this paper is to suggest the necessity of improving the system for victims and victim's family assistance in air accident. In this paper, we analyze the domestic and foreign legal systems and related cases in past accidents, identify the deficiencies of the Korean system, and derive the necessity to improve the related system. It is also important to make sure that victims' families are relieved from early psychological and economic shocks and that the results of accident investigations are reliable. Relevant ministries, airlines, and related agencies should recognize that prompt and systematic assistance and cooperation is needed to ensure that victims and families are relieved of the impact and confidence in the investigation, as is the case in the United States. In addition, efforts should be made to supplement the related laws for the assistance of aircraft victims and victims' families, to establish manuals for implementation, to plan and to implement them promptly in the event of an accident. To achieve this, it is necessary to establish regulations for the legal institutionalization of the roles and responsibilities of national and state agencies on victims of aviation accidents and family assistance. And the victim and family assistance plan that the airline has to submit to it, as specified in the current law, need to specify that item. In addition, new and supplemented contents should be integrated into a single clause or proposed as a separate special law for the purpose of applying a clear law.

A Study on Differentiation and Improvement in Arbitration Systems in Construction Disputes (건설분쟁 중재제도의 차별화 및 개선방안에 관한 연구)

  • Lee, Sun-Jae
    • Journal of Arbitration Studies
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    • v.29 no.2
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    • pp.239-282
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    • 2019
  • The importance of ADR(Alternative Dispute Resolution), which has the advantage of expertise, speed and neutrality due to the increase of arbitration cases due to domestic and foreign construction disputes, has emerged. Therefore, in order for the nation's arbitration system and the arbitration Organization to jump into the ranks of advanced international mediators, it is necessary to research the characteristics and advantages of these arbitration Organization through a study of prior domestic and foreign research and operation of international arbitration Organization. As a problem, First, education for the efficient promotion of arbitrators (compulsory education, maintenance education, specialized education, seminars, etc.). second, The effectiveness of arbitration in resolving construction disputes (hearing methods, composition of the tribunal, and speed). third, The issue of flexibility and diversity of arbitration solutions (the real problem of methodologies such as mediation and arbitration) needs to be drawn on the Arbitration laws and practical problems, such as laws, rules and guidelines. Therefore, Identify the problems presented in the preceding literature and diagnosis of the defects and problems of the KCAB by drawing features and benefits from the arbitration system operated by the international arbitration Institution. As an improvement, the results of an empirical analysis are derived for "arbitrator" simultaneously through a recognition survey. As a method of improvement, First, as an optimal combination of arbitration hearing and judgment in the settlement of construction disputes,(to improve speed). (1) A plan to improve the composition of the audit department according to the complexity, specificity, and magnification of the arbitration cases - (1)Methods to cope with the increased role of the non-lawyer(Specialist, technical expert). (2)Securing technical mediators for each specialized expert according to the large and special corporation arbitration cases. (2) Improving the method of writing by area of the arbitration guidelines, second, Introduction of the intensive hearing system for psychological efficiency and the institutional improvement plan (1) Problems of optimizing the arbitration decision hearing procedure and resolution of arbitration, and (2) Problems of the management of technical arbitrators of arbitration tribunals. (1)A plan to expand hearing work of technical arbitrator(Review on the introduction of the Assistant System as a member of the arbitration tribunals). (2)Improved use of alternative appraisers by tribunals(cost analysis and utilization of the specialized institution for calculating construction costs), Direct management of technical arbitrators : A Study on the Improvement of the Assessment Reliability of the Appraisal and the Appraisal Period. third, Improvement of expert committee system and new method, (1) Creating a non-executive technical committee : Special technology affairs, etc.(Major, supports pre-qualification of special events and coordinating work between parties). (2) Expanding the standing committee.(Added expert technicians : important, special, large affairs / pre-consultations, pre-coordination and mediation-arbitration). This has been shown to be an improvement. In addition, institutional differentiation to enhance the flexibility and diversity of arbitration. In addition, as an institutional differentiation to enhance the flexibility and diversity of arbitration, First, The options for "Med-Arb", "Arb-Med" and "Arb-Med-Arb" are selected. second, By revising the Agreement Act [Article 28, 2 (Agreement on Dispute Resolution)], which is to be amended by the National Parties, the revision of the arbitration settlement clause under the Act, to expand the method to resolve arbitration. third, 2017.6.28. Measures to strengthen the status role and activities of expert technical arbitrators under enforcement, such as the Act on Promotion of Interestments Industry and the Information of Enforcement Decree. Fourth, a measure to increase the role of expert technical Arbitrators by enacting laws on the promotion of the arbitration industry is needed. Especially, the establishment of the Act on Promotion of Intermediation Industry should be established as an international arbitration agency for the arbitration system. Therefore, it proposes a study of improvement and differentiation measures in the details and a policy, legal and institutional improvement and legislation.