20150722 ECA新闻：FDA：生产中断必须提前6个月报告

20150722 ECA新闻：FDA：生产中断必须提前6个月报告

GMP News
22/07/2015

FDA: Manufacturing Disruptions must be reported six Months in Advance

FDA：生产中断必须提前6个月报告

Drug shortage has become a serious problem. Besides problems in the distribution chain, reasons could be manufacturing and quality problems, delays, and discontinuations. The U.S. Food and Drug Administration (FDA) takes more and more efforts to address and prevent drug shortages. In the case of shortage, FDA works closely with manufacturers to communicate the issue and to help restore availability. FDA also works with other firms who manufacturer the same drug, asking them to increase production, if possible, in order to prevent or reduce the impact of a shortage.

药品短缺已成为一个严重的问题。除了销售链的问题外，还可能是因为生产和质量问题、延误以及停产。美国FDA正在采取更多努力来防止药品短缺的发生。在短缺发生时，FDA与生产商紧密合作，沟通相关问题，协助恢复供货。FDA还与其它生产相同药品的公司合作，要求他们在可能的情况下增加生产，以防止或减少药品短缺的影响。

To do so, the FDA needs information about a potential drug shortage as soon as possible and the majority of drug shortage information is provided to FDA by manufacturers. To ensure information is current, the FDA has now published a final rule (FDA-2011-N-0898 Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products) that requires all drug and biologic manufacturers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance, or as soon as is practical, before the disruption causes a shortage.

为此，FDA需要尽可能地获得潜在的药品短缺信息。主要的药品短缺信息由生产商提供给FDA的。为了保证信息及时，FDA现在公布了一份规定终搞（FDA-2011-N-0898永久停产或中断某种药品或生物药品生产），要求所有药品和生物制品生产商采用电子方式提前6个月通知官方其永久停产或生产中断决定，或在可行的情况下，在生产中断会导致药品短缺时通知官方。

多谢楼主分享，谢谢