加快新药临床试验申请滚动提交流程与项目结构
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加快研究性新药（IND）滚动提交流程与项目结构 FDA加快研究性新药（IND）试点项目 滚动提交流程与项目结构 项目概述 | 滚动提交流程与结构 加快IND试点项目的大部分工作将在“pre-IND”阶段进行——即申办方提交正式30天IND申请之前的非临床开发阶段。 在试点期间，申办方仍将负责通过ESG网关向FDA提交信息，并对IND申报资料的完整性承担责任。申办方可选择通过1571表格指定 prospective QRI 作为授权代表，允许其代表申办方向FDA提交，但试点期间不强制要求。 滚动IND提交 申办方将被要求以滚动方式向其PIND提交各学科特定组成部分。在任何组成部分提交至其PIND之前，QRI应已确定该提交是否包含科学合理的依据和数据，并在必要时向申办方提供清晰、可操作的反馈，区分必须解决的问题（以避免临床试验暂停）与可进一步强化申请的机会。这意味着申办方应将QRI视为负责任的科学合作伙伴，其对提交材料的认可构成pre-IND过程中一个有意义的检查点。 申办方可通过ESG门户向其PIND提交特定学科的IND组成部分，供FDA审评。FDA将要求申办方提交滚动IND提交的拟议时间表。FDA不规定具体的提交顺序，而是允许由申办方的发展计划和QRI的指导来确定顺序。该方法旨在最大程度推进FDA与申办方之间的一致性，同时加速IND提交的进程。在高层面上，PIND特定学科组成部分的提交应由申办方/QRI构建为一个独立的、自包含的资料包，而非部分性或碎片化的数据投放，并明确说明申办方寻求达成一致的疑问和观点。关于何为IND组成部分及预期时间表的进一步指导将提供给试点参与者。 一旦所有组成部分均已完成且所有先前反馈均已纳入，申办方将提交最终的IND。如果通过滚动式Pre-IND流程提交所有剩余组成部分会延迟最终IND的提交，则不要求申办方必须通过该流程提交；任何未完成的组成部分可直接在最终IND提交中一并提交。该最终IND提交应包含此前未通过滚动流程提交的所有未完成组成部分，将构成完整的IND资料包，并标志着30天IND审评窗口的启动。在最终提交之前，申办方和QRI应对IND资料包进行最终综合评估，确保其完整性和符合适用的监管标准。 项目评估与跟踪 将要求申办方和QRI在整个试点过程中提供书面和口头反馈，从IND启动活动直至FIH试验启动，反馈内容包括整体流程、经验教训以及QRI在各阶段所发挥的具体作用，例如QRI是仅参与评估已完成的IND组成部分，还是与申办方合作进行开发。这些反馈将使FDA能够及时改进并为该项目的未来迭代提供参考。 FDA对QRI的愿景是成为一个值得信赖的科学合作伙伴。QRI应为IND开发流程带来专业知识和清晰度，帮助申办方开展正确的研究以满足监管标准，同时不引入不必要的负担或延迟。因此，FDA不打算对QRI与申办方就IND组成部分的互动，或QRI与申办方之间的合作模式，强制执行严格的时间表或要求。相反，FDA希望让业界在试点期间找到申办方与研究机构合作的最有效方式，共同目标是加速药物开发并缩短首次人体试验的时间。 更多信息请参阅常见问题解答。 内容截至日期： 09/15/2026 受监管产品 生物制品 药物
正文 · 英文原文
Expedited IND Rolling Submission Process and Program Structure FDA Expedited Investigational New Drug (IND) Pilot Program Rolling Submission Process & Program Structure Program Overview | Rolling Submission Process & Structure A majority of the Expedited IND Pilot will take place during the “Pre-IND” phase – the period of nonclinical development before the sponsor submits their official 30-day IND application. During the pilot, the sponsor will continue to be responsible for submitting information to the FDA through the ESG gateway, and will maintain accountability for the completeness of their IND package. Sponsors may choose to have prospective QRIs act as authorized representatives via Form 1571, allowing them to submit to the FDA on the sponsor’s behalf, but it will not be required during the pilot. Rolling IND Submission Sponsors will be asked to submit discipline specific components to their PIND on a rolling basis. Before any component is submitted to their PIND, the QRI is expected to have determined if the submission incorporates scientifically sound rationale and data, and provided the sponsor with clear, actionable feedback if necessary, distinguishing between issues that must be addressed to avoid a clinical hold and those that represent opportunities for further strengthening the application. This means sponsors should view the QRI as an accountable scientific partner whose endorsement of the submissions is a meaningful checkpoint in the pre-IND process. Sponsors may submit discipline specific IND components through the ESG gateway to their PIND for FDA review. FDA will ask sponsors to submit a proposed timeline for rolling IND submission. Rather than prescribing a specific submission order, FDA will allow the sequence to be determined by the sponsor’s development program and the guidance of the QRI. This approach is intended to best advance alignment between FDA and sponsors while accelerating the path to IND submission. At a high level, PIND discipline-specific component submissions should be framed by the sponsor/QRI as a discrete, self-contained package, not a partial or fragmentary data drop, with a clear statement of what questions and perspective the sponsor is seeking alignment. Additional guidance as to what constitutes an IND component and expected timelines will be provided to pilot participants. Once all components are complete and all prior feedback has been incorporated, the sponsor will submit the final IND. Sponsors are not required to submit every remaining component through the rolling Pre-IND process if doing so would delay the final IND submission; any outstanding components may be submitted directly under the final IND submission. This final IND submission, which should include all outstanding components not previously submitted under the rolling process, will constitute the complete IND package and signal the start of the 30-day IND review window. Before this final submission, the sponsor and QRI should conduct a final comprehensive evaluation of the IND package, ensuring completion and conformance with applicable regulatory standards. Program Evaluation and Tracking Sponsors and QRIs will be asked to provide both written and verbal feedback throughout the pilot from IND-initiating activities until FIH trial initiation, including on the overall process, lessons learned, and the specific role the QRI played at each stage, such as whether the QRI was involved solely in evaluating a completed IND component, or partnering with the sponsor in its development. This feedback will allow FDA to make timely improvements and inform future iterations of the program. FDA's vision for the QRI is that of a trusted scientific partner. The QRI should bring expertise and clarity to the IND development process, helping sponsors conduct the right studies to meet regulatory standards without introducing unnecessary burden or delay. Therefore, FDA does not intend to enforce strict timelines or requirements for QRI interactions with sponsors regarding IND components, or partnership models between QRIs and sponsors. Instead, FDA hopes to allow industry to find the most productive ways for sponsors and research institutions to collaborate during the pilot with the shared goal of accelerating drug development and reducing the time to first-in-human trials. For additional information, see the Frequently Asked Questions. Content current as of: 09/15/2026 Regulated Product(s) Biologics Drugs