為應(yīng)對新型冠狀病毒肺炎（COVID-19）突發(fā)公共衛(wèi)生事件，2020年3月，F(xiàn)DA發(fā)布“FD&C法案506C規(guī)定的永久停產(chǎn)和生產(chǎn)中斷報告指導原則”。該指導原則為申請人和生產(chǎn)企業(yè)及時和詳盡地報告藥品和生物制品生產(chǎn)變化提出建議，以便FDA采取及時有效的措施應(yīng)對可能的短缺藥品，保障美國藥品供應(yīng)鏈穩(wěn)定。該指導原則對完善我國藥品生產(chǎn)中斷報告制度具有參考價值。

In light of the Coronavirus Disease 2019 (COVID-19) public health emergency in America, FDA issued Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry in March 2020. This guidance aimed to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain drugs and biological products, in turn, help the Agency in its efforts to prevent or mitigate shortages of such products, so as to ensure the stability of the medical product supply chain in America. This guidance was still useful for perfecting interruption in manufacturing reporting system of China.