Practical Approaches to Expedite the Review and Approval Process for New Radiopharmaceuticals in Taiwan,Republic of China

Joseph C. Hung

《核子醫學雜誌》 11卷2期 (1998/03) Pp. 34-40

https://doi.org/10.6332/ANMS.1102.002

並列摘要

The legal process for obtaining official approval of anew 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[TechneScan MAG3®],99mTc-bicisate[Neurolite®],and 111In-capromabpendetide[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 muclear medicine community in Taiwan, R.O.C., for patient use.

並列關鍵字

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)