文章詳目資料

Annals of Nuclear Medicine and Molecular Imaging

  • 加入收藏
  • 下載文章
篇名 Commentary on the Current Regulations of Compounded PET Drugs in the United States
卷期 13:1
並列篇名 評論美國的正子造影藥物法規
作者 洪家瑤Jacobson, Mark-S.
頁次 49-55
關鍵字 FDAMAFDANDA/ANDACGMP'scompounded PET drugs正子造影藥物調劑
出刊日期 200003

中文摘要

美國政府於1997年11月21日頒佈“食品藥物管理局(FDA)革新法案",第121項法令專門針對正子造影藥物。該項法規雖然開宗明義將調劑正于這影藥物予以明確詮釋,可是忽略了葉帥對於正子造影藥物之基本調劑權利,於是又緊接著將“優良製造規範(CGMP's(及“新藥審核(NDA/ANDA)"加諸於正于造影藥物的調劑行為。FDA並於1999年9月22日公告\"正于造影藥物優良製造規範"草案。這一連串的法規公佈對於美國核子醫學正子造彩的生存與未來發展帶來相當大的街擊。這些法規將正子造影藥物的調劑行為列為製造及新藥來管理。將來FDA會不會將此案加諸於非正子造彩的藥物仍是個未知數。本文特別討論這幾項新的法令及管理條例,期望為我國葉政主管機關借鏡,將來在制訂國內正子進影藥物管理法案時能建立一套合情合理的法規,提昇國內正子進影科技的發展與順利推廣,造福國人健康。

英文摘要

The U.S. Food and Drug Administration (FDA) is currently developing its regulatory framework for positron emission tomography (PET) drug products in accordance with Section 121 of the Food and Drug Modernization Act (FDAMA), which was issued by the U.S. Congress and signed by the U.S. President into law on November 21,1997. This act directs the FDA to develop procedures [i.e.,new drug application (NDA) and abbreviated new drug application (ANDA)] for approval of PET drugs and current good manufacturing practices (CGMP's) for their production. However, there are several controversial issues related to this law. Not only does it fail to recognize the fundamental right of a pharmacist to compound a PET drug product, but it also stipulates that the compounding process of any PET drug must meet the NDA/ANDA and CGMP requirements which are normally associated with a manufacturing process. The issue of the FDAMA includes a clear directive for the FDA to take into account the relevant differences between commercial and non-profit organizations. The evolution of PET drug production into a viable commercial entity has lead to a polarization of PET facilities in the US. Successful commercial enterprises are able to use their resources to develop CGMP frameworks while institutions dedicated to research or clinical/research programs have, in gen-
eral, scant resources to support such a policy. The idea that non-profit organizations may compound as opposed to the manufacture of PET drugs would result in two sets of standards for PET drug production, which is unacceptable to both the PET community and the FDA. The recently issued draft CGMP's for PET drug products by the FDA on September 22, 1999 provides some clues with regard to the future regulatory mechanism for PET drug products in the US. The document does not directly distinguish between profit and nonprofit organizations as required by FDAMA. However, the draft CGMP regulations try take due account of both types of organizations by not making the regulatory process too restrictive. In this way, the FDA is hoping to make the regulatory process more palatable for all PET drug production facilities. However, when the “one-forall" CGMP regulations are so broad, they become ambiguous, ineffective, and open to misinterpretation. We would like to offer our comments and suggestions as stated in this article to the PET community in Taiwan, Republic of China (R.O.C.) and especially to the Board of Pharmaceutical Affairs, Department of Health, R.O.C. We hope that this article will assist with the development of a sensible and practical regulatory mechanism for PET drugs in Taiwan, R.O.C.so that PET drug products can be used more effectively, affordably, and wideIy in Taiwan, R.O.C.

相關文獻