General Review of Clinical Trial Environment in Japan 2014

In Japan, companies begin researching and developing pharmaceutical products by looking at novel compounds that show promising activity. Then - once they have determined the effectiveness, properties, movement within the body, and toxicity of certain compounds through non-clinical trials - the researchers can progress to human subjects in clinical trials.

The results are submitted to the Minister of Health, Labour, and Welfare for approval, and if the product is approved, it can be commercialized. There are a variety of tasks that exist when implementing clinical trials, and typically these tasks are carried out by an expert from each relevant field. Pharmaceutical companies traditionally used in-house resources to carry out R&D tasks, but what originally became popular mainly among foreign companies, the outsourcing of such tasks to CRO and other such organizations, has now begun to take hold among domestic companies as well.

For quite a while, and until recently, the number of clinical trials within Japan had stagnated, but this trend has begun to be reversed as government initiatives, beginning in 2003, to improve the clinical trial environment for multinational studies has been successful. A number of issues affecting the clinical trial environment within Japan have been indicated previously, including that trials take too long, that the quality is poor, and that they are too costly.

In order to achieve a breakthrough in this situation, the government (MEXT and MHLW) created the 'National Clinical Trial Revitalization Plan' in April of 2003. In addition, striving to further improve the clinical trial environment in Japan, they created the 'New 5-year Clinical Trial Revitalization Plan' in March of 2007.

There has been a certain amount of success based on these initiatives, including an increasing trend in multinational studies, but improvements in study environments in Asian countries such as China and Korea have been progressing at a speed greater than in Japan, and speaking from a global perspective, it is hard to say that the environment for clinical trials in Japan has been greatly improved.

This report talks about the overview of the environment surrounding clinical trials in Japan. As the local professionals have conducted on-the ground research as well as academic research, readers will see what is really going on in Japan. The report also touches some information about other Asian countries such as Korea, China and Taiwan, readers will be able to see overall trend in Asian region.


Key Topics Covered:

I. Summary

II. Pharmaceutical R&D Flow

III. Definition of Clinical Trial

IV. Main Tasks involved in Clinical Trials

V. Laws and Regulations relating to Clinical Development

VI. Outsourcing to External Organizations

VII. Shift in the Number of Clinical Trials

VIII. Issues

IX. Future Outlook

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