Background

The objectives of pharmacy administration that the Department of Health is diligently pursuing are to keep up with the current trend in global pharmacy administration, to seek the greatest welfare for the health of the populace, and to improve the quality of life. In order to achieve rapid growth and development of the pharmaceutical industry in Taiwan, and to enter and compete in the international markets, it is necessary to improve the quality and quantity of new drug approval through combined wisdom and efforts of the government, the researchers, the industry, and the public. ............<more>

Current Status

The Department of Health (DOH) of the Executive Yuan issued an announcement on December 12, 2000, the so-called “Double Twelve Announcement”.  A Guidance of Bridging Study “Ethnic Factors in the Acceptability of Foreign Clinical Data” was announced on May 29, 2002.  The bridging study evaluation was implemented completely since January 1, 2004, according to the Double Twelve Announcement.  The sponsor should apply the bridging study evaluation in accordance with the Double Twelve Announcement, and design the appropriate bridging study protocol(s) to DOH for evaluation in accordance with the recommendation of evaluation.............<more>