PROFILE

It has been fifteen years since the Japan CRO Association (JCROA) was founded in 1994 by voluntary companies engaged in CRO business. On behalf of the JCROA, I would like to express our deepest appreciation to those who have supported our activities over these years.

CRO business started in Japan more than 15 years later than in Europe and the US, and when the Association was established, CROs were not legally recognized in Japan. The JCROA therefore established "Independent Guideline for Proper Performance of Contract Services Proposed by the Japanese CRO Association" immediately after its foundation, and has steadily continued to expand and promote activities to advance the CRO business in Japan. It has also made efforts to bring promising results and win the public confidence through constant negotiation with the regulatory authorities. As a result, the new GCP issued in 1997 legally recognized CROs as providers of services involved in drug development.

The enforcement of the new GCP has obliged pharmaceutical companies to cope with the global standard and develop an infrastructure for clinical trials in Japan. Consequently, pharmaceutical companies began contracting out improvement of the infrastructure for clinical trials to CROs. Thus, CRO business is growing year by year. Meanwhile, it is expected that the strict standards applied to pharmaceutical products will be soon applicable to medical devices and food supplements. In addition to pharmaceutical products, the JCROA has recently established working groups in order to rapidly expand services involved in the development of medical devices and food supplements. In 2008, the JCROA further established the GCP Audit working group and we all are devoting ourselves to provide more promising and better quality of CRO services.

In the future, the ICH will encourage further globalization of the pharmaceutical, medical devices and food industries in Japan and urge these industries to invest in intensive research and development to advance their productivity and value. Under these circumstances, Japanese CROs are becoming increasingly important as outsourcing partners for pharmaceutical, medical devices and food industries. The JCROA hopes to further contribute toward better health and public welfare through CRO business.