Implementation In Japan Research Articles

Electronic Common Technical Document Implementation in Japan

The main missions of the Pharmaceuticals and Medical Devices Agency (PMDA) are the review of drug applications and also being in charge of the electronic common technical document (eCTD) regulations in the review process. However, we believe that we should consider enhancing eCTD implementation with other activities in electronic standardization of clinical trials. With this sense, the Ministry of Health, Labor and Welfare (MHLW) and PMDA are cooperating to enhance eCTD and e-clinical trials in Japan. This article introduces eCTD implementation in Japan, and also our concept for enhancing eCTD submissions in view of the Japanese government initiative for supporting the development of new drugs by the electronic standardization of clinical trials. PMDA is keen to have eCTD submissions and hopes these activities for eCTD will enhance the understanding of our concepts and support the activities of developing drugs in Japan.

ＪＯＧＭＥＣによる金属鉱物資源の探査・環境事業と技術開発 豊羽鉱山におけるペースト充填導入試験とペースト充填が持つ省エネ効果・コスト削減効果について

The paper describes the first attempt of introducing paste backfill in Japan at the Toyoha mine. In 1997, the Metal Mining Agency of Japan (MMAJ), which was reorganized in February of 2004 and currently works as the Japan Oil, Gas and Metals National Corporation (JOGMEC), launched a five year long research program to innovate mining technologies and systems required to save and efficiently use energy in mines. As a part of the program, studies on paste backfill technology and its implementation in Japan were involved.The Toyoha mine was selected as the site for testing paste backfill, since the mine is being operated under an extremely high rock temperature environment. In order to improve the underground climate, the mine decided to introduce paste backfilling and effectively reduce heat flows from mined-out stopes.The first flow test was performed on surface in 1998 and the second flow test was carried out underground in 2001 after having installed the paste fill plant and underground pipelines. The underground test was, however, abruptly discontinued by a mechanical failure, which happened to the PPSM thickener whose bolts holding the drive head at the top of the thickener were broken.After the unpredicted interruption of the paste backfilling test, we have carried out a series of ventilation analyses to evaluate the energy saving effects with paste backfilling under a high rock temperature condition. And we have clarified that remarkable energy saving can be expected by reducing heat flows from mined-out stopes and energy consumption required for underground refrigeration. In addition, it is found that significant cost saving can be also anticipated by curtailing volume of the tailings impoundment and its construction cost.

Shop-Floor Automation and Market Strategy in Japanese Shipbuilding

Effective development and implementation of shop-floor automation is one of the keys to continued Japanese shipbuilding competitiveness. Manufacturing technology is implemented to serve a market strategy, and in many heavy industries (e.g., the manufacture of automobiles and commercial transport airplanes) heavily mechanized production processes are correlated with an exclusive dependence on repeat production. In the case of the Japanese shipbuilding industry, however, extensive automation has not had this result. Instead, shipbuilding automation in Japan is generally designed to support a variety of products, including comparatively simple ship types plus certain kinds of high-value products. Although high-value markets are pursued, the ability to build simpler ship types in a cost-effective manner cannot be abandoned lightly, due to the need to maintain capacity utilization. This position contrasts with that of some European shipyards, which have decided to specialize in high-value special products, such as cruise ships, ferries, and so forth. In this paper, specific cases of automation development and implementation in Japan are reviewed, and we discuss how these types of automation support a two-pronged market strategy.

Monetary Policy Implementation in Japan: What They Say versus What They Do

Since the 1970s, many central banks – including the Bank of England, the Bank of France, the Bank of Korea and the Bank of Japan – have announced that they have ceased direct credit controls. Researchers have tended to accept ‘what they say’, without gathering empirical evidence on ‘what they do’. The Bank of Japan announced that it was abandoning direct credit controls in 1982. Since then, the monetary policy literature on Japan has focussed on formal policy tools, such as interest rates. This paper presents empirical research on the actual implementation of monetary policy by the Japanese central bank. The emphasis is on the period in the mid‐ to late‐1980s when monetary policy was stimulatory and real‐estate‐related lending expanded rapidly, and the period in the early 1990s, when asset prices fell, resulting in the subsequent banking crisis and recession. The paper first briefly surveys the literature. Empirical research is then presented in three parts. Secondary sources are accessed to gain information on the mechanism of monetary policy conduct. New field work is then presented, which uses primary sources to probe the details of monetary policy implementation. Finally, econometric evidence is gathered to test various hypotheses concerning monetary policy procedures. The research successfully establishes the details and nature of the Bank of Japan’s monetary policy implementation during the 1980s and early 1990s. The findings suggest the need for a modification of the generally prevailing view, as well as the need for further research on the actual implementation of monetary policy in other countries.

地球環境問題とランドスケープ 渡り鳥とその生息地保全に係わる国際的活動レベルと地域活動レベルの視点の共有について

Interests of stakeholders of international frameworks for conservation and stakeholders of implementation at site level were analysed by using case studies of the East Asia-Australasia Shorebird Site Network implementation in Japan. We found that the interests of local level stakeholders did not match those of national level proponents of the conservation framework. However identification of potential common interests between the two and execution of appropriate campaign strategy by national-level proponents, which targeted at the common interests, brought mutual benefits and helped to achieve goals of the international framework.

Efficacy of donor screening for HTLV-I and the natural history of transfusion-transmitted infection.

It has been 10 years since the implementation in Japan of donor blood screening for human T-cell lymphotropic virus type I (HTLV-I). This report reviews the effectiveness of screening in preventing transmission of HTLV-I through blood transfusion and the current status of patients with confirmed seroconversion due to transfusions given before the implementation of screening. Patients who received blood at Kyushu University Hospital from 1990 to 1997 were followed. Serum samples were collected before transfusion and 60 days or more after transfusion. Seroconversion was determined by a second-generation particle agglutination test. Confirmation tests were an immunofluorescence assay, enzyme-linked immunosorbent assay, and immunoblotting. Confirmed seroconverted patients were followed by a search of hospital records. Seroconversion was found in one of 4672 transfused patients, but the donor was identified and confirmed to be negative for anti-HTLV-I and virus genome by nested polymerase chain reaction. A total of 23,323 red cell concentrates and 17,237 platelet concentrates were transfused to these 4672 patients. Therefore, the anti-HTLV-I prevalence in blood for transfusion after screening was estimated at 1 in 45,560 (0.0022%; the upper 95% CI was 0.0080%). One hundred two seroconverted patients who were transfused before donor screening for HTLV-I were followed. One patient developed HTLV-I-associated myelopathy, diagnosed 18 weeks after seroconversion, and another patient developed uveitis 1 month after seroconversion. No patients developed adult T-cell lymphoma, and the survival rate of seroconverted patients was 92.5 percent 15 years after transfusion. This study confirmed that the present donor screening program for HTLV-I by the new particle agglutination test can almost completely prevent virus transmission by transfusion. Complications of HTLV-I transmission were at lower rates than expected.

UN Economic Sanctions and Domestic Implementation in Japan

UN Economic Sanctions and Domestic Implementation in Japan