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Japan Bioindustry Letters

Vol.23 No.3-1 Japan Association of Bioindustries Executives (JABEX) Announces Clinical Study Reform Proposals

The Japan Association of Bioindustries Executives (JABEX), chaired by Mr. Katsuhiro Utada, established a committee in October 2006 to promote reforms in clinical research. The committee, chaired by Mr. Osamu Nagayama of Chugai Pharmaceutical Company president, is focusing on fundamental solutions that will enable broad-scale reforms in clinical trial frameworks.
At the committeefs meeting on December 21, 2006, it concluded with the following interim proposals related to boosting clinical trial activity and accelerating the new drug approval process by way of system reforms and other pertinent strategies.

(1) Establishment of a committee whose goal is to improve the competitive strength of the medical and health industries as a mechanism for achieving national consensus
? Overall policies and methods for resolving issues concerning clinical trials should be determined followed by discussions among cabinet-level policymakers and representatives from the medical industry and others
? How industrial policies can best serve society and people is to be discussed
? The role as a conning tower is desired

(2) Establishment of two gnational clinical trial promotion model centersh
? Goal is to establish a suitable clinical trial framework as a business model
? Devote substantial resources to these centers and operate independently from existing organizations and frameworks
? Cooperate with core clinical trial hospitals and leading medical organizations to promote the model nationwide

(3) Develop a globally competitive system for examination/approval of new drugs
? Complete to double the staff number of Pharmaceuticals and Medical Devices Agency (PMDA) by 2010
? Deregulate PMDA employment conditions and implement other improvements
? Review GCP standards, establish examination guidelines and improve examination/approval processes in order to promote joint international clinical trials and stimulate clinical trial activity in Japan

(4) Increase government spending in clinical research and unify life science policies to promote constant innovation and commercialization

The committee plans to release a final report on its finings by March 2007.



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