non-Japanese Companies Research Articles

Oncology drug lag in Japan: has it improved over the last decade?

Existing studies and statistics on the drug lag between Japan and the United States (US) for anti-cancer drugs indicate that it has decreased, whereas more drugs are left unapproved in Japan. This study aimed to quantify the impact of unapproved drugs on the drug lag. Information on 136 anti-cancer drugs approved in the US between 2011 and 2022 was collected. The approval lag, defined as the number of days from the date of approval in the US to the date of approval in Japan, was calculated for all selected drugs, and the median was calculated using the Kaplan-Meier method. The approval lag for drugs not approved in Japan was treated as censored data. Factors potentially associated with the approval lag were explored using Cox regression analysis. The median approval lags for the first half-period (2011-2016) and the last half-period (2017-2022) were 961 days (2.6 years) and 1547 days (4.2 years), respectively (Log-rank test: p = 0.0687). The participation of Japan in the global pivotal trial was associated with a shorter approval lag, and new drug applications by non-Japanese companies that did not rank in the global sales top 20 were associated with a longer approval lag. Drug lag has not decreased over the last decade. The percentage of pivotal trials for US approval that included Japan has increased but should be further increased in the future. Japan may require a scheme to encourage smaller non-Japanese companies to include Japan in their global clinical development plan.

Comparison of New Drug Indications Approved in the United States, Europe, and Japan from 2001 to 2020.

In Japan, there have been many requests for off-label drugs from academic societies or patient groups to the "Evaluation Committee on Unapproved or Off-labeled Drugs with High Medical Needs." Thus, drug indications in Japan may be limited compared to those in other countries. To clarify whether drug indications in Japan are limited, the drugs containing new active ingredients approved in Japan, the United States, and Europe from 2001 to 2020 and sold in these three regions as of the end of 2020 were identified and their indications were compared. The indications of antineoplastic agents, psycholeptics, drugs from non-Japanese companies, and drugs approved in Japan from 2011 to 2020 were limited in Japan and Europe compared to the United States. These trends were more notable among antineoplastic agents. Thirty-seven indications for 19 antineoplastic agents were approved in the United States but not in Japan, and the most common indications were urothelial carcinoma (4), hepatocellular carcinoma (3), and thyroid cancer (3). The numbers of indications and drugs with different indications in Japan and Europe were generally comparable, and no specific imbalance was observed. The same indications of antineoplastic agents should be made promptly available in Japan and Europe as in the United States, as malignancy is one of the leading causes of death.

Differences in Sports Sponsorship Activation between Japanese and Non-Japanese Companies in Emerging Countries : The Example of the SEA GAMES in 2017

Differences in Sports Sponsorship Activation between Japanese and Non-Japanese Companies in Emerging Countries : The Example of the SEA GAMES in 2017

Comparative Study of TQM Practices between Japanese and Non-Japanese Companies: Proposed Conceptual Framework

In todays highly competitive market, the demand for quality is a critical factor for organization to survive in the ever-expanding global marketplace. The concept of total quality management (TQM) has been developed as a result of intense global competition. Japanese companies have had superior achievement, and left their counterparts, non-Japanese far behind. One of the TQM strength practices in Japanese companies is technical aspects; tools and techniques namely statistical process control (SPC), total productive maintenance (TPM) and lean production. The purpose of this paper is to compare TQM practices between Japanese and non-Japanese companies, and develop the conceptual framework based on extensive review of the literature. Three theories; institutional theory, system theory and contingency theory have been identified and applied in this study for developing conceptual framework. Based on literature review, Japanese companies have higher TQM practices compared to non-Japanese companies. Furthermore, this study proposes that SPC, TPM and lean production are mediators for TQM in Japanese companies. This proposed research will help the academicians and industry players to have better understanding of TQM implementation in order to improve business performance effectively in the future.

Comparative study of TQM practices between Japanese and non-Japanese electrical and electronics companies in Malaysia: Survey results

Total quality management (TQM) is a crucial concept in ensuring that companies survive in this increasingly competitive global market. Japanese companies are very successful because of the adoption and implementation of TQM principles expounded by quality gurus such as Deming, Juran, Taguchi and others. In order to survive in the global market with intense competition between regions and enterprises, the adoption of TQM practices is essential to ensure business excellence. Many non-Japanese companies particularly in the Malaysian context are still in the initial stage of TQM implementation. This piece of work relates to a study on the comparison between Japanese companies and non-Japanese companies in Malaysia with regard to TQM practices. A questionnaire was prepared and sent to 370 companies from the electrical and electronics sector in Malaysia which gave a 21.9% response rate. Attempts were made at finding significant differences between Japanese and non-Japanese companies with regard to TQM practices and the companies' view of the importance thereof. It was found that there are significant differences in TQM practices between Japanese and non-Japanese companies. Management leadership, measurement and feedback, product design and education and training are the significant factors, which shows the strength of Japanese companies with superior practices in these four factors as against non-Japanese companies. There are no significant differences in perception of the importance of TQM between Japanese and non-Japanese companies except for the product design factor. This study shows that Japanese companies place high importance on product design and they believe quality starts from design and in turn will determine manufacturability, reliability and product quality. This points to the need for much greater emphasis to be placed on future quality improvement programmes for local companies. Further studies can be made focusing on the other types of industry in Malaysia, such as automotive, food processing and metal-based, to develop a comprehensive TQM implementation framework to be built upon to meet the needs of Malaysian industries in their drive towards achieving TQM practices.

Delays in New Drug Applications in Japan and Industrial R&D Strategies

The gap between Japan and both the United States (US) and the European Union (EU) with regard to access to new drugs is becoming a major issue in Japan. We analyzed the time lags involved in new drug application (NDA) and biological license application submissions in Japan, the US, and the EU in order to identify the causes of delayed access. The time lag related to submission of applications ("submission lag") was longer for in-licensed products and for non-Japanese companies. Factors related to costs of clinical studies and potential volumes of sales were not associated with the submission lag. A bridging strategy (extrapolative use of foreign clinical data in the clinical data package based on International Conference on Harmonisation guideline E5) seemed to reduce submission lag, but the association between the two diminished when the cause-and-effect relationship was specifically investigated. These results suggest that multinational companies are likely to place more emphasis on the choice of development strategies that successfully lead to their goal rather than on direct costs and expected sales when deciding to introduce their pharmaceutical products in Japan. Our findings indicate that the clinical development guidances that helps pharmaceutical companies decide on investment and strategies are also the key to narrowing the gap in access to new drugs.

The effects of the keiretsu on the export performance of Japanese companies: help or hindrance?

This study investigates the effect that membership in a financial keiretsu has on the export performance of Japanese manufacturing companies. Companies that belong to one of the six major financial keiretsu are found to have lower export ratios than similar companies who are not members. The negative effects of keiretsu membership appear confined to producer goods companies where intergroup linkages such as preferential trading relationships are tightest. Additional evidence from the producer goods sector showing that keiretsu members do less well on other measures of company performance supports the argument that the cartel-like properties sometimes ascribed to the keiretsu actually reduce competitiveness, thus dampening export performance. In general, the data do not support recommendations that non-Japanese companies might look to keiretsu-type alliances as an organizational strategy that will lead to competitive advantage in global markets. © 1998 John Wiley & Sons, Ltd.

The Relative Importance of Supplier Selection Criteria: The Case of Electronic Components Procurement in Japan

INTRODUCTION In academic articles, and even more so in the popular business press, Japanese industrial purchasing behavior has been painted with a single brush. The Japanese purchaser-supplier relationship is typically described as cooperative, interdependent, integrated, and, often, exclusive. Outside sellers, especially non-Japanese companies, are rarely able to penetrate this relationship. However, this characterization of Japanese industrial purchasing was always overstated. It may have accurately depicted purchaser-supplier relations in a small number of industries, most notably the automobile industry. But the portrayal failed to distinguish between different sectors of the Japanese economy, not to mention individual companies or products. Furthermore, although the pace has been painfully slow, many segments of the Japanese market have been opening up to foreign competition. This study examined purchasing behavior in the Japanese electronic (SIC 3600) and office equipment (SIC 3570) industries. The research objective was to asses and compare the relative importance of several vendor selection criteria used by Japanese electronic and office equipment companies when making purchases of two different types of components: standard switches and printed circuit boards. A switch was selected as representative of standard components. A printed circuit board, on the other hand, is often customized, and electronic firms generally rely on outside suppliers' technologies.[1] Two sets of hypotheses are presented. The first seeks to determine whether or not purchasers in the electronic and office equipment industries accord more weight to maintaining relationships with current suppliers than to so-called rational factors such as price, quality, and delivery. Furthermore, does the answer depend upon whether companies are purchasing standardized or customized components? The second group of hypotheses examines and compares the relative importance of several rational product and supplier attributes when companies purchase these two different types of components. LITERATURE REVIEW AND HYPOTHESES Supplier Relationship There have been several recent studies of purchaser-supplier alliances in the Japanese automotive industry.[2] Japanese manufacturers within each of the keiretsu have established close subcontracting relationships with some of their suppliers. In this partnership, the purchasing firm gives the supplier an exclusive or semi-exclusive contract. The supplier in turn invests in customized machinery or other facilities. The relationship is often enhanced by mutual shareholding. This emphasis upon maintaining the purchaser-supplier relationship gives rise to the following hypotheses: H1a: When purchasing standard switches, purchasers attach significantly greater importance to cross-shareholding, reciprocity, and the fact that the supplier is a subsidiary than to rational purchase decision-making factors (quality, price, and delivery). H1b: When purchasing printed circuit boards, purchasers attach significantly greater importance to cross-shareholding, reciprocity, and the fact that the supplier is a subsidiary than to rational purchase decision-making factors (quality, price, and delivery). H2a: When purchasing standard switches, purchasers attach significantly greater importance to cross-shareholding, reciprocity, and the fact that the supplier is a subsidiary than to a supplier's performance attributes (manufacturing, technical and design capabilities). H2b: When purchasing printed circuit boards, purchasers attach significantly greater importance to cross-shareholding, reciprocity, and the fact that the supplier is a subsidiary than to a supplier's performance attributes (manufacturing, technical, and design capabilities). Parallel Sourcing A number of studies[3] have concluded that single-source purchasing (a company purchases a component from only one supplier) is common in Japan. …

The adoption of international best practices in a Western culture: East meets West

Contemporary organizations facing changing economic and strategic realities have considered many models of organizational performance, in particular those based on ‘actices’odels of best practice have emanated from the USA, some European countries and Japan; however, the question remains –ternational best practices be transferred to Australia or elsewhere? Since companies in Japan, in particular, have been seen as harbingers of these best practices, we compare the level of adoption in Japanese and non-Japanese companies in three Australian industries. Differences between Japanese and non-Japanese companies were more apparent in the automotive industry with only a few differences found for the information and tourism industries. The main differences between the two ownership categories were in areas of unionization and management–elations, that is, areas that may be influenced more by institutional arrangements than by cultural differences. Perhaps the most interesting finding from the comparative research...