Health policy in new drug development in Taiwan: A preliminary report of a case study.

摘要

Successful research and development of new pharmacological therapeutics require effective integration of scientific, clinical, and government regulatory abilities. The Republic of China on Taiwan is a newly-industrializing economy whose government regards the pharmaceutical sector as a high value-added, low pollution profile industry. In fact, the government of Taiwan has declared participation in the global pharmaceutical drug development industry a priority. A significant policy-based commitment is development of the Good Clinical Practice (GCP) executive order. GCP standards are commonly practiced by nations with an established full-scale pharmaceutical industry. By comparison, neither Taiwan's domestic pharmaceutical sector nor the government regulatory authority is familiar with the practice or enforcement of GCP standards.; The purpose of this dissertation is to evaluate the implementation of GCP standards in Taiwan. A major challenge is Taiwan's lack of history and culture in the GCP-standardized clinical development and enforcement process. The significance of the research is contribution of knowledge about an emerging health policy in Taiwan with local, regional, and worldwide public health implications. Information is derived from interviews and participant observations conducted with government, industry, and academic opinion-leaders in the United States and Taiwan. Limitations of the research methodology, while present, do not significantly impact the preliminary research findings.; Empirical evidence suggests the presence of emerging capabilities in the political, economic, and public health environments. Specifically, effective implementation of the GCP mandate in Taiwan depends upon: (1) Taiwan's development of an NCE or a technology platform in all phases of clinical investigation through request for regulatory approval; (2) consolidation of Taiwan's chemical, pharmaceutical, scientific, and clinical research entities into an integrated R&D system; (3) the development of regulatory expertise in the DOH in technical content, management, and enforcement of GCP standards; (4) modification of cultural characteristics to accommodate the needs of the pharmaceutical industry in conformance with GCP standards.; This dissertation reviews Taiwan's initial efforts in the practice and enforcement of GCP standards. Further research is needed to evaluate the long-term impact of the GCP executive order on Taiwan's evolving public health environment.