Drug development in Japan: Opportunities and challenges in drug development

As Japan becomes more integrated into the global market, pharmaceutical research and development (R&D) in the country faces considerable challenges. While global simultaneous drug development including Asian countries has become a common feature for multinational pharmaceutical companies, Japan has also been frequently set aside because of its unique regulatory requirements and provincial clinical trial infrastructure. To counter this, pharmaceutical companies operating in Japan have been working to improve their efficiency. As a result, a gradual but measurable improvement in the clinical trial environment has been witnessed over the past several years - including a reduction in average study duration. Meanwhile, a tremendous number of improvement programmes focussed on the biopharmaceutical industry have been initiated in conjunction with Prime Minister Shinzo Abe's vision of innovation for Japan. With this increased scrutiny, significant improvements in regulatory process, clinical trial costs and site performance are anticipated over the next few years. At the same time, efforts to promote the field of pharmaceutical medicine in Japan are ongoing. A number of academic institutions have established education and training programmes in drug development and regulatory science. In addition, collaborative initiatives between academia and industry to set standards and establish qualification for the specialists in drug development are continuing with the hope that the number of experts in drug development in Japan will increase. It is hoped that, together, these positive trends will revitalise Japan as a leading global player in pharmaceutical R&D in the Asian region and beyond. © 2007 Adis Data Information BV. All rights reserved.