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<p>美国食品药品监督管理局已开始接受参与 FDA PreCheck 试点项目的请求。</p>
<p>FDA PreCheck 旨在通过提高监管可预测性、促进在美国建设制造基地以及简化特定产品申请前的制药制造设施评估，来加强国内制药供应链。</p>
<p>FDA 专员 Marty Makary 表示：“在全球化者将制药制造转移到海外 35 年后，FDA 正在采取大胆措施将其带回美国。PreCheck 项目是我们提供的几个强有力激励措施之一，旨在使美国制药制造行业更加有韧性和竞争力。”</p>
<p>FDA 表示，将选择一批新的制药制造设施，并于 2026 年开始进行 PreCheck 活动。设施的选择将基于与国家优先事项的整体一致性，考虑多个选择标准，如要生产的产品、设施开发阶段、为美国市场生产制药产品的时间表以及设施开发的创新性。对生产美国市场关键药物的设施将给予额外的优先考虑。</p>
<p>FDA 在项目设计中纳入了广泛的行业反馈，这些反馈基于 2025 年 9 月 30 日举行的 “药物和生物产品制造回流” 公开会议期间的评论，以及通过联邦公报发布的公众评论。行业强烈支持在设施开发早期进行参与，并简化文档流程。</p>
<p>如有意见和反馈，请联系：editorial@rttnews.com</p>
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<p>美国食品药品监督管理局（FDA）启动了 PreCheck 试点项目，旨在通过提高监管可预测性和促进制造场地建设来增强国内药品供应链。FDA 专员 Marty Makary 强调，该倡议旨在将制药制造业带回美国。该项目将根据与国家优先事项的一致性选择新的制造设施，重点关注关键药物。FDA 在项目设计中纳入了行业反馈，旨在实现早期参与和简化流程</p>

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</div><p>The U.S. Food and Drug Administration has begun accepting requests to participate in the FDA PreCheck pilot program.</p>
<div class="lb-trans"><p>美国食品药品监督管理局已开始接受参与 FDA PreCheck 试点项目的请求。</p>
</div><p>FDA PreCheck is designed to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of manufacturing sites in the U.S., and streamlining aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application.</p>
<div class="lb-trans"><p>FDA PreCheck 旨在通过提高监管可预测性、促进在美国建设制造基地以及简化特定产品申请前的制药制造设施评估，来加强国内制药供应链。</p>
</div><p>&#34;After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back,&#34; said FDA Commissioner Marty Makary. &#34;The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive.&#34;</p>
<div class="lb-trans"><p>FDA 专员 Marty Makary 表示：“在全球化者将制药制造转移到海外 35 年后，FDA 正在采取大胆措施将其带回美国。PreCheck 项目是我们提供的几个强有力激励措施之一，旨在使美国制药制造行业更加有韧性和竞争力。”</p>
</div><p>FDA said it will select an initial group of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities in 2026. Facilities will be selected based on overall alignment with national priorities across multiple selection criteria, such as products to be manufactured, phase of facility development, timeline to producing pharmaceutical products for the U.S. market, and innovation in facility development. Additional priority consideration will be given to facilities producing critical medications for the U.S. market.</p>
<div class="lb-trans"><p>FDA 表示，将选择一批新的制药制造设施，并于 2026 年开始进行 PreCheck 活动。设施的选择将基于与国家优先事项的整体一致性，考虑多个选择标准，如要生产的产品、设施开发阶段、为美国市场生产制药产品的时间表以及设施开发的创新性。对生产美国市场关键药物的设施将给予额外的优先考虑。</p>
</div><p>The FDA incorporated extensive industry feedback into the program design based on comments made during the &#34;Onshoring Manufacturing of Drugs and Biological Products&#34; public meeting held on Sept. 30, 2025, and public comments received through Federal Register publication. Industry strongly supported early engagement during facility development and streamlined documentation processes.</p>
<div class="lb-trans"><p>FDA 在项目设计中纳入了广泛的行业反馈，这些反馈基于 2025 年 9 月 30 日举行的 “药物和生物产品制造回流” 公开会议期间的评论，以及通过联邦公报发布的公众评论。行业强烈支持在设施开发早期进行参与，并简化文档流程。</p>
</div><p>For comments and feedback contact: editorial@rttnews.com</p>
<div class="lb-trans"><p>如有意见和反馈，请联系：editorial@rttnews.com</p>
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FDA 启动预检试点计划以强化制药生产