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題 名 | Practical Approaches to Expedite the Review and Approval Process for New Radiopharmaceuticals in Taiwan, Republic of China |
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作 者 | Hung,Joseph C.; | 書刊名 | 核子醫學雜誌 |
卷 期 | 11:2 1998.04[民87.04] |
頁 次 | 頁34-40 |
分類號 | 414.93 |
關鍵詞 | 放射性藥物; Radiopharmaceuticals; Review and approval processes; U.S. food and drug administration; FDA; Food and drug administration modernization act of 1997; FDAMA; Bureau of pharmaceutical affairs; BOPA; |
語 文 | 英文(English) |
英文摘要 | The legal process for obtaining official approval of a new drug, including radiopharmaceuticals, in any country is usually lengthy and expensive. The complexity of the regulatory process and the associated costs involved in bringing a new radioactive drug to market are the major reasons for the limited availability of radiopharmaceuticals. In Taiwan, Republic of China (R.O.C.), the number of different radiopharmaceuticals available to practicing physicians using radioactive drugs is even less than in other advanced countries. Some commonly used radiopharmaceuticals in other parts of the world, such as 99mTc-mertiatide [Techne Scan MAG3], 99mTc-bicisate [Neurolite], and 111ln-capromab pendetide[Prosta], are simply not available in Taiwan, R.O.C. There is a relatively small market for radioactive drugs in Taiwan, R.O.C., and the majority of the radiopharmaceuticals currently available in Taiwan, R.O.C., are imported from other countries. Therefore, the enticement of foreign radiopharmaceutical manufacturers who are willing to bring new radioactive drugs that have already been approved in other countries or regions to Taiwan, R.O.C., is an urgent issue that will have a significant impact on the continuous growth of the nuclear medicine field and proper patient care in Taiwan, R.O.C. It is essential for the Bureau of Pharmaceutical Affairs (BOPA), Department of Health, R.O.C., to develop a more efficient and responsive system to review and approve new radioactive drugs (especially imported radiopharmaceuticals) in order to adequately address the aforementioned critical issue. This article offers some practical approaches to assist the BOPA in streamlining the regulatory process in order to make new radiopharmaceuticals more rapidly and widely available to the nuclear medicine community in Taiwan, R.O.C., for patient use. |
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