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Reasons for Establishing Association

The association was established to facilitate the healthy development of the clinical reagent industry by seeking to strengthen our organizational structure and improve our operational capabilities in our role as the industry body, with an important obligation to satisfy public expectations by studying the underlying purpose of in vitro diagnostics and acting in compliance with the relevant statutes while also working toward the development and wider adoption of high-quality and high-performance products through the development and adoption of advanced technologies.


Clinical reagent committees have been sitting as standing committees of the Pharmaceutical Manufacturers’ Association of Tokyo and Osaka Pharmaceutical Manufacturers Association and investigating the legal role of clinical reagents since 1965, with further ongoing deliberations into the clarification of this following the designation of these reagents as pharmaceuticals under the Pharmaceutical Affairs Law. In the clinical reagent industry, meanwhile, a decision was made to consult on and actively engage in bringing together interested parties and unifying the industry, which was going through period of major transformation in which there were calls for greater consolidation, leading to the establishment of the Japan Association of Clinical Reagents Industries with the approval of the Minister for Health and Welfare on May 2 1989, building on groundwork laid in the form of an industry body established in November 1983 with a membership of 87 companies active in the field of in vitro diagnostics. In April 2012 approval was received to change from a “shadan hojin” (incorporated association) to an “ippan shadan hojin” (general incorporated association), with the association’s Japanese name being changed accordingly. As of October 2015, the association had 127 member companies with collective sales of more than 500 billion yen, and it serves as a major pillar of the industry that contributes to clinical testing in Japan and the progress of the industry. The association also continues to establish and actively run a variety of expert committees in order to identify the issues associated with clinical reagents both internally and externally and to pursue further targeted and forward-looking activities while also taking ongoing steps to work with other relevant industry bodies, including membership of the Federation of Pharmaceutical Manufacturers’ Associations of Japan, which represents the Japanese pharmaceutical industry, to encourage a wider range of business activities in accordance with its objectives.