In a bid to supply the nation with the world's top-level pharmaceuticals and have the industry serve as a growth engine, we formulated a five-year strategy in 2007, which was positioned in the New Growth Strategy drawn out in 2009. We are now taking measures to realize the aim. More specifically, the measures include improvement of the pharmaceutical review system aiming for faster and better review , promotion of global clinical trials for simultaneous development and approval throughout the world, and clarification of approval standards such as establishing guidelines on vaccines, regenerative medicines and others.

NHI drug pricing system, which determines drugs covered by insurance and their prices for reimbursement has affected to some extent research and development of new drugs in Japan. I will present impact of the recent NHI drug pricing system reform on research and development of new drugs in the future. In particular, I will focus on "premium for the development of new drugs and elimination of off-label drug use" which will be introduced on a trial under the reform in FY2010 in order to promote the development of innovative new drugs and to deal with pressing issues such as "drug lag".

R&D strategies for drugs have been changing depending on the advancement of life science. This presentation will focus on a future outlook of drug development with an eye to this change. Pharmaceutical business strategies for which the industry, government and academia work together will be indispensable for Japan to show the existence value in drug development toward the world.

EFPIA Japan has had the reduction of the drug lag as its priority objectives for many years. Some progress has been made in the recent past thanks to the effort of innovative pharmaceutical companies and regulators.
It is critical for Japanese patients to have access to drugs approved in the USA and Europe and not yet in Japan. Multiple approaches need to be taken but clear regulations and guidelines as well as rational incentives would contribute to the resolution of the drug lag.
The presentation will cover several suggestions on the regulatory front as well as on the design of the incentives.

The pharma industry is one for which there are great expectations. But the R&D cost of medicine, especially bio-medicine, is increasing rapidly. And international competition is growing more intense. Last November the Ministry of Economy, Trade and Industry (METI) established a council to discuss programs to stimulate the pharma industry, especially bio-medicine. The findings of this council will be announced in this lecture.

The pharmaceutical industry is facing crucial issues such as patent expirations of blockbusters, low R&D efficiency, slow market growth in developed countries, and high growth in emerging countries. Consequently, companies are searching for new strategies. To establish a new business model for the pursuit of diversity and efficiency, Chugai joined the Roche group in 2002 and has achieved growth, particularly from biopharmaceuticals in the areas of cancer and arthritis. Here, further growth strategies will be presented for Chugai, which aims to be a top Japanese pharmaceutical company.

Kyowa Hakko Kirin (KHK) was newly launched as R&D based company in Japan on October 1, 2008 by consolidation of two bio-pharmaceutical companies. KHK has original technologies to create first-in-class antibody pipelines; POTELLIGENT® for enhancing ADCC, KM-Mouse for making fully human antibodies, and so on. Several antibodies applied with these technologies were developing by the ideal strategies (in-house development, out-license, and technology alliance) for each antibody to accelerate product development. KHK will strive for delivery of innovative therapeutic antibodies to patients with an incurable disease.

PhRMA's main goal in Japan is to bring innovative medicines to patients in a way that maximizes safety, efficacy, and speed. Last year saw a number of positive developments, including greater recognition of the importance of innovation with agreement on a new drug pricing system, increased understanding that healthcare is an investment in people and society and not just a budget cost, continuing improvements in the drug review process, and an increased emphasis on preventive care. However, despite these developments, much still needs to be done in 2010.

The share of generic drugs has already reached 60%-70% of the market for prescription drugs in the United States, Canada, Germany, and Britain, respectively. However, it still remains in 20% in Japan. Under these situation, the Japanese government has set 30%, by 2012 as the target of the generic drug's utilization rate.
At this seminar, we will look at the current market situation of generic drugs in Japan. Furthermore we will discuss the promotive campaign for generic drug's utilization by the Japanese government such as the reimbursement fee revision in 2010, flat payment system and change of prescription form.

Teva-KOWA Pharma was established as a joint venture of Kowa Company, Ltd. which has a half century history in Japanese pharmaceutical industries and Teva Pharmaceutical Industries Ltd., No. 1 Generic Maker in the world. Our sales activity has started from January 2010. We would like to explain overview of our business strategy in Japanese generic industry where changing the circumstances.

Needs of Generic drugs is increasing in Japan, at the same time in the global Generics market, leading multinational originator companies have started entering Generics market. In this seminar, the global Generics market trend as well as Japanese market from the global point of view will be shared. In addition, our business strategy as a Global generics company, as well as the strategy for Japanese market will be presented.

The Japanese generic drug market is attractive to multi-national generic firms in respect of its market potential, but it is also a difficult market as these companies have to better deal with various structural factors pertaining to this market.
In fact, top companies on a global basis have gained a very small market share in Japan. In other words, generic products that are commonly used in the world are not used very much in Japan.
This speech intends to provide a source of perspective on success factors for multi-national generic firms in the Japanese market.

Key persons involved with the generic drugs market in Japan discuss the regulations and strategies necessary for the wide scale use of generic drugs.

Are you still facing difficulties or have questions regarding the registration of Master File System for Drug Substances, the process of accreditation of foreign manufacturers, or the application for GMP Compliance Inspection for Foreign Manufacturers? Under cooperation of, the Japan Generic Medicines Association, the Japan Pharmaceutical Traders Association, established in 1963 as the only organization of pharmaceutical importers authorized by the Minister of Health and Welfare, will respond to your questions and provide you with practical advice based on their experiences of trading business to assist you with your future business development in Japan. Representatives from the Pharmaceuticals and Devices Agency, the regulatory body that reviews marketing authorization applications for pharmaceuticals and medical devices, will also participate in this session.
*We will send registered participants a questionnaire form in order to collect your questions or information about obstacles you have encountered in complying with the Revised Pharmaceutical Affairs Law. Please feel free to inform us what you want to know about the law before your attending the workshop. 　

2010 will be the year of "CHANGE" in the world of Chemical Substance Management. The first REACH registration deadline in November this year is approaching for substances produced and imported into the EU in the volume above 1,000t/yr. Furthermore, taking measures to meet the requirements of CLP regulation in Europe, Revision of Chemical Substance Control Law in Japan, Indirect Food Additives and New Chemical Substance Management Law in China will become necessary. Meeting the challenges of regulatory compliance is a differential business strategy in itself and infallible decision is crucial for indusutries.