The Strategies of the Health Authority (in Taiwan) when Facing the Issues of Global Supply of Drugs

• Main Authors: JAU-JIE HUANG, 黃兆杰
• Other Authors: Jen-Wei Cheng
• Format: Others
• Language: zh-TW
• Published: 2009
• Online Access: http://ndltd.ncl.edu.tw/handle/79097874859623547071

碩士 === 國立臺灣科技大學 === 管理研究所 === 97 === Owing to the Globalization, the issue of drug safety has emerged in recent years. Moreover, a series of drug, food safety incidents occurred because of the expanding of Chinese market. Most of the countries have established some policies to resolve the problems of global supply of drugs. There is no exception in Taiwan as well. In 2010, "Food and Drug Administration" will be set up under the authority of the Department of Health which is expected to perform as FDA of the USA government. That is, "Food and Drug Administration" will be in charge of the management mechanism of the safety of the food, drug and health. It is crucial for government to construct one specific department to integrate all the policies, tests and researches, and gain the synergy of administrative uniformity and efficiency. However, is it capable for government to face any crises of food, drug and health only because of the establishment of "Food and Drug Administration"? This study choose the qualitative methodology and try to discuss several issues of global supply of drugs, taken methods of facing global supply of drugs, and role playing of those international drug-related organizations or groups. In addition, this study sums up several international trends and principles then compares them to the strategies which Taiwanese government adopted in the past and present. Finally, this study presents the conclusions and recommendations. According to the conclusions of this study, the three agenda of global supply of drugs are the examination of drug, the quality of drug manufacturers, and the safety tracking of drug use. And the administration of Taiwanese government has also drawn up proper strategies for the three agenda above. Nevertheless, this study found that there is still something to be done. Therefore, the recommendations of this study are as follows: First, the merger of the drug administration couldn’t resolve the whole present situation of global supply of drugs. Instead, the empowerment of professional organization matters most. Second, the establishment of regulations is not completed enough, including the review, integration, and complementary measures. So, the future FDA may assign a particular unit to organize and make better supporting measures. Third, the demanded achievement of GMP (PIC/S GMP) during manufacturing will not reduce the risks of global supply of drugs. Therefore, the study suggests that the government re-examine the entire pharmaceutical supply chain, in particular the security of supply of raw materials. Forth, the adaptation of the latest international GMP standards won’t improve the shortage of inspection manpower, and the shortage will influence the domestic pharmaceutical industries a lot. Consequently, the complementary measures are greatly suggested. Last, especially about the safety tracking of drug use, this study recommends that the government reconstruct the corresponding organization and contact window during Taiwan's participation of World Health Organization (WHO) in 2009 again. Besides, the key to be succeeding in future assignments are the full development of human resources and well management of projects.