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The Affiliate was inaugurated in June 2002 largely in response to the rapidly increasing need in Japan for a more complete understanding of overseas regulations and guidelines applying to the pharmaceutical industry, notably in the US and Europe. It was well recognized that ISPE International would be the ideal conduit for up-to-the-minute information on the quickly-evolving demands made of manufacturers.

Meanwhile, the Japanese pharmaceutical market continued to expand as a result of its graying population, and the Affiliate found considerable favor with its program of Seminars and Conferences. Moreover, it soon began to play the key role of providing translations of technical documents already published in the English language, promoting a further enhanced understanding of overseas requirements by the membership.

To accomplish its goals, the Affiliate has in recent years energetically reorganized itself. The Board of Directors comprising five (5) Officers, twenty (20) Directors and three (3) Adjunct Directors draws widely from the pharmaceutical industry in Japan. The majority of functions are conducted by one or more of the 13 COPs, each under a leader, while certain specialty tasks/events are undertaken by dedicated Committees.

The Affiliate takes pride in the direct involvement in its COPs by approximately 60% of the country-wide membership. This is the engine for the successful program of events and tasks accomplished. However, it never fails to recognize the high level of support received from pharmaceutical neighbors, both near and far, and looks forward to a further enhanced collaboration in the years to come.