近日，F(xiàn)DA更新了其政策和程序手冊（MAPP）——5014.1 Rev. 1《CDER基于風險的選址模型》。該文件詳細說明了FDA將如何根據(jù)選址模型（SSM）優(yōu)先考慮受檢查單位。本次更新增加了一個風險考慮因素：公司所在國家或地區(qū)的合規(guī)歷史，包括該國家或地區(qū)出口的（受此類法規(guī)約束的）產(chǎn)品相關的違規(guī)歷史。
原文如下：
The SSM will use risk factors consistent with section 510(h)(4) of the FD&C Act. This provision identifies specific risk factors and allows FDA to determine additional ones, as follows:
SSM（選址模型）將使用符合FD&C法案第510（h）（4）條的風險因素。該條款確定了特定的風險因素，并允許FDA確定其他風險因素，如下：
a) The compliance history of the establishment.
公司的合規(guī)歷史。
b) The record, history, and nature of recalls linked to the establishment.
與該公司相關的召回記錄、歷史和性質(zhì)。
c) The inherent risk of the drug or device manufactured, prepared, propagated, compounded, or processed at the establishment.
該公司藥物或器械的固有風險。
d) The inspection frequency and history of the establishment, including whether the establishment has been inspected pursuant to section 704 of this title [the FD&C Act (21 U.S.C. 374)] within the last 4 years.
該公司的檢查頻率和歷史，包括在過去4年內(nèi)是否根據(jù)FD&C法案（21 U.S.C. 374）第704條對該公司進行了檢查。
e) Whether the establishment has been inspected by a foreign government or an agency of a foreign government recognized under section 809 of this title [the FD&C Act (21 U.S.C. 384e)].
該公司是否已接受外國政府或根據(jù)FD&C法案（21 U.S.C. 384e）第809條認可的外國政府機構的檢查。
f) The compliance history of establishments in the country or region in which the establishment is located that are subject to regulation under this Act [the FD&C Act], including the history of violations related to products exported from such country or region that are subject to such regulation.
該公司所在國家或地區(qū)的合規(guī)歷史，包括該國家或地區(qū)出口的（受此類法規(guī)約束的）產(chǎn)品相關的違規(guī)歷史。
g) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.4
為分配檢查資源而必要和適當?shù)娜魏纹渌麡藴省?/span>
另一項更新為：藥品質(zhì)量辦公室（OPQ）內(nèi)一個部門名稱由“監(jiān)督辦公室”變更為“質(zhì)量監(jiān)督辦公室（OQS）”。
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