Abstract
Since 1993, the government of Taiwan has allocated approximately $60 million to help the pharmaceutical industry in the area of biotechnology and pharmaceutical science research and development. The government has chosen to promote drug research and development as part of a national policy to target the pharmaceutical manufacturing industry as one of Taiwan's strategic industries. To cope with this development, it is essential that more efforts are made to improve policies and regulations relating to drug regulatory affairs. After the International Conference on Harmonization III (ICH 3), held in Japan in 1996, a consensus among academia, industry, and Taiwan's Department of Health (DOH) was reached that a steering committee called ICH Taiwan should be established to deal with global trends.
It is anticipated that ICH Taiwan will integrate all the individual efforts described in this paper to harmonize with ICH. It will also serve as an efficient mechanism and organization to participate in future ICH activities.
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