Evaluation of research and development activites in universities, national laboratories and other governmental organizations has been implemented since the "General Guidelines for Evaluation of National Research and Development Activities"was established in August 1997. The current evaluation criteria include the number of published papers, frequency of citations and number of patents granted, which are not adequate for subject areas where the number of papers does not count, and therefore do not allow comparison between different subject areas. Another problem is that, whereas evaluation of a program before starting the research is a clear-cutone with a go/no-go result, the result of interim evaluation or evaluation of final results is not clearly reflected in the policy. In other words, the current evaluation system dose not provide a feedback mechanism to achieve more effective and efficient distribution for research resources. A system in which evaluation results are reflected in research planning, with a flexibility allowing for reevaluation, is urgently required.

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Introduction of the practice based on the International Conference on Harmonization-Good Clinical Practice(ICH-GCP)has provided an international satandard for drug development, and enabled applications for approval of new drugs to the Japanese Government on the basis of clinical trial results obtained in other countries. Actually, however, clinical trials based on ICH-GCP are almost infeasible in Japan, since the ICH guidelines, particularly the GCP, are rooted in Western healthcare systems and customs. Their incongruity with the Japanese practices has already produced confusion. The present paper discusses the problems for each of the four participants in clinical trials : administration, pharmaceutical industry, doctors and medical institutions, and patients. The author elucidates the origins of the problems and proposes possible steps to solve them. These problems belong to obstacles for Japan's "internationalization"along with many others in finance, administration, research and education.

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Life sciences including drug development will certainly be the leading industry in the 21st century, following information technology. A peculiarity of this area is requirements of ethical nature as exemplified by the problems of genetic engineering. Japan has not been successful in developing science and technology policy in the field of health care. Health care should be incorporated in a system of science and technology policy, covering all aspects in basic and clinical research along with popularization, as well as those in promotion, evaluation and regulation. This paper reviews American and European policies on life science research and health care as a first step to identify the goal and problems of the Japanese policy to be established in future.

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Development of truly epoch-making new drugs is always related to innovative discoveries or theories of highest level. Fruit of development efforts by corporate scientists, such drugs are rooted in academic research in national laboratories or universities. In resent years, however, success in basic research often leads to establishment of a small venture enterprise, which acquire a wide range of patents for its potential products. This trend, particularly prominent in the U.S., makes a published paper rather a belated starting point of a drug development program. The lead-time until commercialization of a drug, estimated to be about 13 years, is correspondingly being shortened to about five years in near future. These circumstances urge pharmaceutical companies to perform some basic research by themselves. Takeda is trying to base its target of drug development efforts on studies of orphan receptors and their ligands. Innovative pharmaceuticals should result from discovery of new orphan receptors/ligands and enzymes in genomic study. This approach will necessitate further advances in technology as well as reflections on the methodology.

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General aspects of drug development are reviewed and problems in modern drug development management are discussed in relation to global networking. Recent changes experienced in drug development have two major factors : innovative technologies derived from basic research, such as genomics, and expansion of global networking in development including clinical trials. The latter is motivated by the need to handle a large amount of data obtained in the process of development utilizing informatics. Another important aspect of modern drug development is strategy that allows timely decision making. Increased investment on drug discovery and globalized clinical studies has resulted in higher risk. The author reviews present circumstances of management in the pharmaceutical companies which have global development systems.

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Creative research and development and the resulting original business ares are necessitated in today's Japan, as never before, for economic growth, employment creation and contribution to the rest of the world. The government has recognized"risk"for the first time as a leading concept in official publications : Chapter 3 of the newest edition of the White Paper on Economy is entitled"For Creation of Ordered Risk". Innovation is the driving force of economic growth but never free from risk. Although legislative measures for promotion of venture capitals have been taken and the budget for science and technology have been increased, Japan suffers from shortage of persons with talent to lead the risky innovative developments, while the traditional education has produced a huge population for administration and control : there is a gap between supply and demand of talented people. The present work contains a survey of data and opinion related to this problem. The gap is reflected in technological trade balance(particularly the low level of patent applications to other countries), industry's view on capabilities of new employees and the present status of graduate students. The problem seems to lie in poor understanding of the competitive situation for the industry by the educational circle, as well as in the time lag between industrial innovation and academic reform. Mutual understanding of the industry and academia in a common platform is needed to fill the gap. The author states that creative people is the most important asset for Japan to obtain a status of an advanced country.

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This paper is based on an analysis of R&D globalization of 14 large corporations in the electronics and pharmaceutical sectors in Japan. It is based on a systematic analysis of bibliometric data, combined with analysis of survey data. Our findings suggest that in both industries, R&D globalization has gained momentum in the 1990s. We analyzed the R&D activities carried out by foreign-affiliated institutions independently, as well as through collaboration with foreign universities and public sector research centres. The electronics sector started the globalization process earlier than the pharmaceutical sector. The results from statistical analysis show that variation exists in the degree and pattern of R&D globalization among firms in the same sector. Analysis of the motives for R&D globalization suggests that technology factors are important for both industries. While technology factor is more important for the electronics sector, technology and demand factors are both important for the pharmaceutical sector.

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The paper aims at inquiring current competitive structure of the Japanese TV game-soft industry. Our analysis is based on our database covering 298 firms in 1997. Our hypothesis is : competitiveness of the industry depends on emergent industrial cluster seen in Tokyo, i.e."Tokyo Game-soft Cluster". Our findings include an identification of eight clusters whose attributes are characterized by participating firms'different market entry and their having different related market segments. The most competitive cluster is"Yamanote Line Cluster"located in the left-hand side of the circle line.

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