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近日，F(xiàn)DA 宣布擴(kuò)大對(duì)國(guó)外食品、藥品及醫(yī)療產(chǎn)品制造工廠的不預(yù)先通知檢查（突擊檢查或飛行檢查）范圍，旨在消除雙重標(biāo)準(zhǔn)，使外國(guó)公司與美國(guó)國(guó)內(nèi)公司接受同等監(jiān)管。FDA 還將改進(jìn)相關(guān)政策和做法，明確檢查人員需拒絕受監(jiān)管企業(yè)提供的差旅住宿，以維護(hù)監(jiān)督公正性。

原文及翻譯如下

FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

美國(guó)食品藥品監(jiān)督管理局宣布擴(kuò)大對(duì)國(guó)外制造工廠的不預(yù)先通知檢查的使用范圍

Today, the U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients. This change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.

今天，F(xiàn)DA宣布將擴(kuò)大對(duì)食品、基本藥物和其他醫(yī)療產(chǎn)品的國(guó)外制造工廠進(jìn)行不預(yù)先通知檢查的范圍。這一變化是基于該機(jī)構(gòu)在印度和中國(guó)的檢查和調(diào)查辦公室的國(guó)外不預(yù)先通知檢查試點(diǎn)項(xiàng)目，旨在確保外國(guó)公司受到與國(guó)內(nèi)公司相同水平的監(jiān)管監(jiān)督和審查。

“For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track,” said FDA Commissioner Martin A. Makary, M.D, M.P.H.

“長(zhǎng)期以來(lái)，外國(guó)公司一直享受雙重標(biāo)準(zhǔn) —— 在工廠檢查前收到預(yù)先通知，而美國(guó)制造商則在沒有此類通知的情況下被要求達(dá)到嚴(yán)格的標(biāo)準(zhǔn)。這種情況從今天起結(jié)束。這是 FDA 在使國(guó)外檢查重回正軌的更廣泛戰(zhàn)略中的關(guān)鍵一步，” 美國(guó)食品藥品監(jiān)督管理局局長(zhǎng)馬丁?A?馬卡里醫(yī)學(xué)博士、公共衛(wèi)生碩士說(shuō)。

In addition, the FDA will evaluate the agency’s policies and practices for improvements to the foreign inspection program to ensure that the FDA is the gold standard for regulatory oversight. These changes will include clarifying policies for FDA investigators to refuse travel accommodations from regulated industry including lodging and transportation arrangements (taxi, limousine, and for - hire vehicle transit), to maintain the integrity of the oversight process.

此外，F(xiàn)DA 將評(píng)估該機(jī)構(gòu)的政策和做法，以改進(jìn)國(guó)外檢查計(jì)劃，確保 FDA 成為監(jiān)管監(jiān)督的黃金標(biāo)準(zhǔn)。這些變化將包括明確 FDA 檢查人員拒絕受監(jiān)管企業(yè)提供的差旅住宿的政策，包括住宿和交通安排（出租車、豪華轎車和租車運(yùn)輸），以維護(hù)監(jiān)督過(guò)程的完整性。

The FDA conducts approximately 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. While U.S. manufacturers undergo frequent, unannounced inspections, foreign firms have often had weeks to prepare, undermining the integrity of the oversight process. Despite the advanced warning that foreign firms receive, the FDA still found serious deficiencies more than twice as often than during domestic inspections.

FDA 每年在 90 多個(gè)國(guó)家進(jìn)行約 12,000 次國(guó)內(nèi)檢查和 3,000 次國(guó)外檢查。美國(guó)制造商經(jīng)常接受不預(yù)先通知的檢查，而外國(guó)公司通常有幾周的時(shí)間準(zhǔn)備，這破壞了監(jiān)督過(guò)程的完整性。盡管外國(guó)公司收到了預(yù)先通知，但 FDA 發(fā)現(xiàn)嚴(yán)重缺陷的頻率仍然是國(guó)內(nèi)檢查的兩倍多。

Only in specific programs and cases are the FDA’s domestic inspections pre - announced to assure that appropriate records and personnel will be available during the inspection. But regulated companies do not have the authority to negotiate the day or time of the inspection— nor should foreign companies have the capability to do so either.

只有在特定的計(jì)劃和情況下，F(xiàn)DA 的國(guó)內(nèi)檢查才會(huì)預(yù)先通知，以確保在檢查期間有適當(dāng)?shù)挠涗浐腿藛T在場(chǎng)。但受監(jiān)管的公司無(wú)權(quán)協(xié)商檢查的日期或時(shí)間 —— 外國(guó)公司也不應(yīng)該有這樣的權(quán)利。

With this shift, the FDA is further ensuring that every product entering the U.S. is safe, legitimate, and honestly made. Unannounced inspections will also help expose bad actors—those who falsify records or conceal violations—before they can put American lives at risk. The FDA is authorized to take regulatory action against any firm that seeks to delay, deny, or limit an inspection, or refuses to permit entry for an unannounced drug or device inspection.

通過(guò)這一轉(zhuǎn)變，F(xiàn)DA 進(jìn)一步確保進(jìn)入美國(guó)的每一種產(chǎn)品都是安全、合法和誠(chéng)信制造的。不預(yù)先通知的檢查還將有助于在不良行為者（那些偽造記錄或隱瞞違規(guī)行為的人）危及美國(guó)人的生命之前揭露他們。FDA 有權(quán)對(duì)任何試圖拖延、拒絕或限制檢查，或拒絕允許進(jìn)行不預(yù)先通知的藥品或器械檢查的公司采取監(jiān)管行動(dòng)。

“The FDA’s rigorous, science - based global inspections of manufacturing facilities ensure that the food and drug products that enter the U.S. marketplace, and the homes of American consumers, are safe, trusted, and accessible,” said FDA Assistant Commissioner for Inspections and Investigations Michael Rogers. “These inspections provide real - time evidence and insights that are essential for making fact - based regulatory decisions to protect public health.”

“FDA 對(duì)制造工廠進(jìn)行的嚴(yán)格的、基于科學(xué)的全球檢查確保了進(jìn)入美國(guó)市場(chǎng)和美國(guó)消費(fèi)者家庭的食品和藥品是安全、可靠且可獲取的，”FDA 負(fù)責(zé)檢查和調(diào)查的助理局長(zhǎng)邁克爾?羅杰斯說(shuō)。“這些檢查提供了實(shí)時(shí)證據(jù)和見解，對(duì)于做出基于事實(shí)的監(jiān)管決策以保護(hù)公眾健康至關(guān)重要。”

The FDA’s global inspections generate real - time intelligence that strengthens enforcement and keeps American families safe. Every inspection goes through a classification assignment process to enable an appropriate regulatory response. Even inspections that yield a “No Action Indicated” provide important regulatory intelligence that strengthens the safety net for American consumers.

FDA 的全球檢查生成實(shí)時(shí)情報(bào)，加強(qiáng)了執(zhí)法力度，保障了美國(guó)家庭的安全。每次檢查都要經(jīng)過(guò)分類分配過(guò)程，以便做出適當(dāng)?shù)谋O(jiān)管反應(yīng)。即使是得出 “無(wú)需采取行動(dòng)（NAI）” 結(jié)論的檢查也能提供重要的監(jiān)管情報(bào)，加強(qiáng)了美國(guó)消費(fèi)者的安全保障。

This expanded approach marks a new era in FDA enforcement—stronger, smarter, and unapologetically in support the public health and safety of Americans.

這種擴(kuò)大的檢查方式標(biāo)志著 FDA 執(zhí)法進(jìn)入了一個(gè)新時(shí)代 —— 更強(qiáng)大、更明智，并且毫不含糊地支持保障公眾的健康和安全。