On December 15, 2025, the U.S. Food and Drug Administration issued two final guidances, “Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices” and “Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.”
The first guidance is intended for investigators, industry, and institutional review boards (IRBs). This final guidance provides recommendations to help clinical investigators comply with the safety reporting requirements for investigational new drug application (IND) studies and investigational device exemption (IDE) studies as part of their responsibility to protect the rights, safety, and welfare of study participants. The guidance also streamlines and incorporates information from previous guidances to aid stakeholders in easily referencing key information.
The second guidance provides recommendations to help sponsors comply with the expedited safety reporting requirements for human drug and biological products that are being investigated under an IND, or as part of a bioavailability (BA) or bioequivalence (BE) study that is exempt from the IND requirements.
These two final guidances replace the recommendations for investigators and sponsors to comply with safety reporting requirements previously provided in the final guidance documents “Safety Reporting Requirements for INDs and BA/BE Studies” (December 2012) and “Adverse Event Reporting to IRBs—Improving Human Subject Protection” (January 2009); accordingly, FDA has withdrawn the 2012 and 2009 guidance documents.
An unofficial translation of this announcement is provided below.
翻译参考：
FDA 发布两项关于安全性报告要求和安全性评估的指导原则
2025年12月15日，美国食品药品管理局（FDA）发布了两份最终指南，分别为《研究者职责——研究性药品和医疗器械的安全性报告》和《申办方职责——IND及生物利用度/生物等效性研究的安全性报告要求与安全性评估》。
第一份指南适用于研究者、产业界以及伦理审查委员会（IRB）。该最终指南提出建议，旨在帮助临床研究者履行其保护研究参与者权利、安全与福祉的职责，以符合研究性新药申请（IND）和研究性医疗器械豁免申请（IDE）研究中的安全性报告要求。同时，该指南对以往相关指南文件中的内容进行了整合与简化，便于相关方查阅和参考关键信息。
第二份指南提出相关建议，旨在帮助申办方遵守加速安全性报告的要求。这些要求适用于在 IND监管框架下开展的人用药品和生物制品的研究，或适用于免于 IND 要求的生物利用度（BA）或生物等效性（BE）研究中的相关产品。
这两份最终指南取代了此前在《IND 及 BA/BE 研究的安全性报告要求》（2012 年 12 月）和《向 IRB 报告不良事件——加强受试者保护》（2009 年 1 月）两份最终指南中针对研究者和申办方提出的安全性报告的合规建议。因此，FDA 已正式撤回上述 2012 年和 2009 年的指南。
Sincerely,
Sarah McMullen
Country Director
FDA China Office
Office of Global Operations
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