Jun./2010
(STRATEGIC PROPOSALS)
Challenges for Life Innovation/CRDS-FY2010-SP-01
Executive Summary

Our country has moved into a hyper-aged society, such that we are seeing soaring medical costs and greater medical needs as the size of the elderly population increases. While the rest of the world is also experiencing an aging trend, emerging countries are seeing an increase and diversification in their medical needs. Consequently, the healthcare industry's move into international markets is a trend being seen in the advanced countries. The field of medicine as an industry is expected to increasingly develop in the future due to these increased and diversified medical needs on a global scale.
The factors such as the remarkable progress in biotechnology have led to great advances in medical technology. The advances in these technology will also lead to the revitalization of the medical industry. Our country faces, however, a range of problems that hinders any revitalization, resulting in lower growth of the overall medical industry. To get past these current circumstances, it is necessary to strongly promote technological innovation in the medical, care, and health fields, that is, strive for “life innovations.” These life innovations can be expected to make it possible to provide the most up to date medical services in a safe and timely manner and with the healthcare economic validity, while the medical industry can be expected to be not only a growing and leading industry but also act as a driving force for future higher economic growth and job creation.
To realize these life innovations, it is necessary to establish and improve both systems and research environments. The government will be required to take a major role in bringing this about, in addition to government-industry-academia collaboration. Therefore, we recommend that the government apply the following five measures.

Development of human resources to be involved in clinical research
Development of human resources required for translational research and clinical research that form the foundation of life innovations, establishment of systems for assessing clinical research results etc., and the introduction of clinical research fellowships
Further promotion of clinical research and reinforcement of research?support systems
Establishment of clinical research institutions and assist centers (clinical research assist center etc.), promotion of basic research that contributes to the immediate implementation of clinical research, information exchange and mutual understanding between regulators and clinical research institutions/assist centers through personnel exchanges, and reinforcement of the registration system for cancer and other major diseases
Reformation of regulation
Unification and reinforcement of review and approvals systems for medicinal products and medical devices etc. by the introduction of a Japanese version of the IND system on the basis of the creation of a medicines agency as a government organ (a Japanese version of the FDA)
Establishment of office-ministry collaboration
Efficient use of research funds and infrastructure by revitalization and reinforcement of the existing Health Research Promotion Council, and the development of comprehensive policies for clinical research and support for the policies
Support for bio-ventures and formation of special zones
Introduction of a Japanese version of the SPA system, establishment of a system for securing research funds and support for the system by the Industry Innovation Organization etc., the formation of special zones, and the reform and deregulation of existing systems