Promotion of Life Innovation, and resolution of drug/device lag were emphasized in the final draft of combined reform on tax and social security, which was endorsed by Cabinet meeting at July 1st, 2011. Also, strengthening regulatory science, and reinforcement of human resources are required in the 4th Basic Plan for New Science and Technologies, endorsed by Cabinet meeting at August 19th.
This presentation will provide an update on the new drug review and introduce the Regulatory and Scientific Consultation for Strategic Development of Drug and Medical Device, which has just started its service from July,2011.
*Opening ceremony will be before the beginning of the seminar.

Against the backdrop of dramatic economic and political changes on a global scale, such as the substantial rise of emerging economies and unprecedented economic crisis in developed countries, the pharmaceutical industry, just like other industries, has recently been caught up in the midst of strong waves of change.
In this presentation, those changes will be shown to in fact be a good opportunity to strengthen our pharmaceutical business in the future. Consequently, the pharmaceutical industry's growth strategy will be considered mainly from two viewpoints: the product business mix, including innovative, generics, etc., and the geographical mix, including developed and emerging markets.

To introduce how Astellas saw and predicted the global pharmaceutical market in 2005 and describe Astellas' background and the strategy to be Global Category Leader (GCL).

Information is provided on definitions, similarities, differences, quality and corresponding regulations and guidance of products used in pharmaceutical production. Recent scandals, such as the melamine found in infant formula or tainted heparin — made the industry wake up and served as the catalyst for working together. Industry initiatives establishing common acceptable standards to improve product quality and patients' safety and overcome global challenges will be highlighted. Merck Millipore has foreseen the needs and requirements and launched its Emprove® brand pharmaceutical raw materials. Emprove® combines a high quality product with use-related suitable documentations.

Vaccines are drugs that prevent diseases such as infectious diseases, and Ministry of Health, Labour and Welfare is also committed to taking measures against pandemics and introducing innovative vaccines. Although improvement in the product lineup in Japan has been seen, many foreign vaccines are still unapproved in Japan, and thus the “vaccine gap”. Recently, R&D of therapeutic vaccine become active and business chance of vaccine field will expand in the near future. This lecture will present the vaccine environment and current business status in Europe, predict future vaccine business landscape in Japan and make proposals to close the vaccine gap.

For a product to be supplied in the market as a drug, pharmaceutical companies must follow set procedures, prepare necessary documents, submit applications to the Ministry of Health, Labour and Welfare, and obtain their approval. To do this, companies must have the results of a clinical study. During drug development, we will especially focus on these clinical studies, and work towards creating clinical development plans and improving their efficiency. We will also discuss challenges. Along with explaining these procedures, we will introduce the activities carried out by JPMA's Drug Evaluation Committee.

Pharmaceutical quality assurance has been to assure the quality of manufactured products complying with GMP beginning with acceptance of raw materials. In proportion to the rapid diversification of suppliers of raw materials, quality-related issues have grown rapidly in recent years. In order to achieve consistent quality assurance from upstream to downstream throughout supply chain, it is essential to verify quality management system of raw material suppliers through auditing and also to establish quality assurance system for distributing released products to customers without jeopardizing product quality.

The expectation on research and development of biologics is growing high as innovative treatment for patients who suffer from diseases with high unmet medical needs. On the other hand, biologics manufactured based on gene recombinant and cell culture technologies have various issues attribute to complexity and heterogeneity of its structure such as quality control of manufacturing and long term safety and immunogenicity. The issues in development and manufacturing characteristic of biologics will be discussed.

Under circumstances of low economic growth and progress in aging, the government promotes using generics as a one of the effective countermeasures to streamline the healthcare cost in Japan. The barrier between long-listed products and generics could be vague in the future. It will be key issue to fine-tune our business model without being bound by existing frameworks by finding out new market needs from any environmental transformations.

The landscape in the pharmaceutical industry has been rapidly changing for both innovators and generic companies over the last few years. Outsourcing/ procurement and supply chain management have become more challenging and the need for a strategic relationship between buyer and supplier has become imperative. The relationship has moved towards being a strategic business partner rather than buyer and supplier.

The use percentage of generic drugs is increasing steadily, but further promotion measures are necessary for achievement of the government goal. I introduce some main measures in FY 2012 Revision of Medical Fee for further promotion of generic drugs.

Promoting generic drug use is the current goal of 30%(volume basis) is to achieve the end of 2012. To achieve this goal, every year until now (Chairman of Japan Society of Generic Medicine) "Policy Recommendations" have been conducted for officials. Announced last year "2011 Policy Recommendations" for, for their content and effectiveness, as well as policy recommendations to support the research, I'll explain.