近日，FDA 发布了《行业指南：远程监管评估（RRA）指南—问答》，该指南将远程监管评估（RRA）正式确立为常态化监管工具 —— 文件包含：哪些主体可能受到远程监管评估？远程监管评估是否正在取代其他既定的非检查获取信息的方式？FDA何时可能启动或要求进行远程监管评估？远程监管评估的要求？企业在远程监管评估期间可能预期会发生什么？远程监管评估完成后可能会发生什么？等问题的解答：

以下为指南的原文及其翻译
Guidance for Industry

行业指南

Conducting Remote Regulatory Assessments

开展远程监管评估

Questions and Answers

问答

June 2025

2025年6月

Table of Contents目录
I. Introduction一、介绍

II. Background二、背景

III. Questions and Answers三、问答

A. Remote Regulatory Assessment FundamentalsA. 远程监管评估基础

1. What is an RRA?1. 什么是远程监管评估（RRA）？

2. Who may be subject to an RRA?2. 哪些主体可能接受远程监管评估？

3. Are RRAs replacing other established means of obtaining information outside of inspections?3. 远程监管评估是否正在取代其他既定的非检查获取信息的方式？

4. Is an RRA an inspection?4. 远程监管评估是一种检查吗？

5. When may FDA initiate or request to conduct an RRA?5. 美国食品药品监督管理局（FDA）何时可能启动或要求进行远程监管评估？

6. Will FDA use RRAs during or as part of an FDA inspection of an establishment?6. FDA 在对企业进行检查期间或作为检查的一部分时会使用远程监管评估吗？

7. What are the benefits of an RRA?7. 远程监管评估的好处是什么？B. Remote Regulatory Assessment ExpectationsB. 远程监管评估预期

8. How may FDA request an RRA?8. FDA 如何要求进行远程监管评估？

9. What might an establishment expect to happen during an RRA?9. 企业在远程监管评估期间可能预期会发生什么？

10. Are there any consequences for declining to participate in an RRA?10. 拒绝参与远程监管评估会有什么后果？

11. Are there any technological expectations for an RRA?11. 对远程监管评估有哪些技术方面的预期？C. Requests for Records or Other Information as Part of Remote Regulatory AssessmentsC. 作为远程监管评估一部分的记录或其他信息请求

12. What records or other information may FDA request as part of an RRA?12. FDA 作为远程监管评估的一部分可能会要求哪些记录或其他信息？

13. For what purposes may FDA use the records and other information gathered during an RRA?13. FDA 使用在远程监管评估期间收集的记录和其他信息的目的是什么？

14. If the RRA requests records or other information, what is the timeframe for submitting the records and other information to FDA?14. 如果远程监管评估要求提供记录或其他信息，向 FDA 提交这些记录和其他信息的时间框架是怎样的？

15. How should records or other information in response to an RRA request be provided to FDA?15. 应如何向 FDA 提供对远程监管评估请求作出回应的记录或其他信息？D. Completion of a Remote Regulatory AssessmentD. 远程监管评估的完成

16. What may occur upon completion of an RRA?16. 远程监管评估完成后可能会发生什么？

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page.

本指南代表了FDA 对该主题的当前想法。它不会为任何人确立任何权利，对 FDA 或公众也没有约束力。如果满足适用法规的要求，您可以采用替代方法。若要讨论替代方法，请联系标题页所列负责本指南的 FDA 工作人员或办公室。

I. Introduction一、引言
In response to the Coronavirus Disease 2019 (COVID - 19) pandemic, FDA adapted its operations for field activities to provide oversight of regulated industry while mitigating the spread of COVID - 19. One set of tools used during the COVID - 19 public health emergency for oversight of FDA - regulated products was remote regulatory assessments (RRAs). The term “RRA” (as defined in the Question and Answers section) is used to describe a category of activities for which FDA may use different terminologies, but that are all considered to be types of RRAs, including “remote interactive evaluations” and “remote record reviews.” Such activities, along with others identified in this guidance, are considered RRAs for purposes of this guidance. When faced with travel restrictions during the COVID - 19 pandemic, FDA used RRAs to assess establishments and their compliance with applicable FDA requirements. Based on this experience FDA has noted the value of RRAs and concluded that they are a beneficial oversight tool outside the COVID - 19 pandemic and for a range of FDA - regulated products.FDA has developed this guidance to provide answers to frequently asked questions related to RRAs. This guidance is intended to help enhance industry's understanding of RRAs, thereby facilitating FDA's process for conducting RRAs. The guidance finalizes the revised draft guidance of the same title issued on January 26, 2024 (89 FR 5244).

为应对 2019 冠状病毒病（COVID - 19）大流行，FDA 调整了其现场活动的操作方式，以便在减轻 COVID - 19 传播的同时对受监管行业进行监督。在 COVID - 19 公共卫生紧急事件期间，用于监督 FDA 监管产品的一套工具是远程监管评估（RRAs）。“RRA” 一词（在问答部分定义）用于描述一类活动，FDA 可能会使用不同术语来称呼这类活动，但它们都被视为 RRA 的类型，包括 “远程互动评估” 和 “远程记录审查”。就本指南而言，此类活动以及本指南中确定的其他活动被视为 RRA。在 COVID - 19 大流行期间面临旅行限制时，FDA 使用 RRA 来评估企业及其对适用 FDA 要求的合规情况。基于这一经验，美国食品药品监督管理局（FDA）已认识到远程监管评估（RRAs）的价值，并得出结论：在新冠疫情之外，对于一系列 FDA 监管的产品而言，RRAs 是一种有益的监管工具。FDA 制定了本指南，以解答与 RRAs 相关的常见问题。本指南旨在帮助加强行业对 RRAs 的理解，从而促进 FDA 开展 RRAs 的流程。该指南最终确定了 2024 年 1 月 26 日发布的同名修订草案指南（《联邦公报》第 89 卷，第 5244 页）。

Throughout this guidance, the terms, “FDA,” “the Agency,” “we,” “us,” and “our” refer to the Food and Drug Administration. In this guidance, the term “establishment” includes any facility, entity, person, importer, or site, whether foreign or domestic, subject to the laws administered by FDA.在本指南中，“FDA”、“机构”、“我们”、“我们的” 等术语均指美国食品药品监督管理局（Food and Drug Administration）。在本指南中，“企业” 一词包括受 FDA 监管法律约束的任何场所、实体、个人、进口商或地点，无论其位于国外还是国内。

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended but not required.FDA 的指南文件，包括本指南，并不构成具有法律强制执行力的责任。相反，指南文件描述了我们对某一主题的当前想法，应仅被视为建议，除非引用了特定的法规或法定要求。机构指南中 “应该”（should）一词的使用意味着某事物是被建议或推荐的，而非强制要求的。

Ⅱ. Background二、背景
FDA uses a variety of tools5 for oversight of FDA-regulated products and establishments. During the COVID-19 pandemic, FDA used RRAs to help the Agency conduct oversight, mitigate risk, and meet critical public health needs with respect to certain FDA-regulated products. RRAs have included: (1) mandatory6 RRAs involving review of records or other information submitted by certain establishments upon request from FDA under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); (2) mandatory reviews of records from food importers subject to section 805 of the FD&C Act 7 (hereinafter referred to as “requests for Foreign Supplier Verification Program (FSVP) records under 21 CFR 1.510(b)(3) or 1.512(b)(5)(ii)(C)”); and (3) voluntary RRAs involving remote requests for records and/or interactive evaluations (such as remote livestreaming video of operations, teleconferences, and screen sharing).FDA 使用多种工具对受其监管的产品和企业进行监督。在新冠疫情期间，FDA 使用远程评估（RRAs）来帮助该机构进行监督、降低风险，并满足对某些受 FDA 监管产品的关键公共卫生需求。远程评估包括：（1）根据《联邦食品、药品和化妆品法案》（FD&C 法案）第 704 (a)(4) 条，应 FDA 要求，某些企业提交的记录或其他信息的强制性远程评估；（2）根据《联邦食品、药品和化妆品法案》第 805 条（以下简称 “外国供应商验证计划（FSVP）记录要求”，见 21 CFR 1.510 (b)(3) 或 1.512 (b)(5)(ii)(C)'）对食品进口商记录的强制性审查；以及（3）涉及远程记录请求和 / 或互动评估（如远程操作视频直播、电话会议和屏幕共享）的自愿远程评估。
FDA has identified significant benefits in using RRAs. For instance, RRAs have assisted FDA in verifying corrective actions taken in response to inspections of previously compliant manufacturers8 and in gaining compliance insight when it was not practicable to inspect. RRAs have also provided information about deficient practices, leading FDA to take regulatory actions and/or conduct inspections, as well as informing future inspection planning. RRAs were used to help support review and promote timely approval or authorization of marketing submissions for FDA-regulated products. In the food programs, RRAs have assisted in determining compliance with veterinary feed directive regulations, assessing foreign manufacturing process records, adding foreign establishments to import alerts, and issuing warning letters.美国食品药品监督管理局（FDA）已确定使用远程评估（RRAs）具有显著益处。例如，远程评估协助 FDA 核实先前合规的制造商针对检查所采取的纠正措施，并在实地检查不可行时获取合规情况的见解。远程评估还提供了有关缺陷做法的信息，促使 FDA 采取监管行动和 / 或进行检查，同时也为未来的检查规划提供信息。远程评估被用于支持审查并促进及时改进或纠正营销宣传声明。在食品计划中，远程评估有助于确定是否符合兽药饲料指令法规，评估国外生产过程记录，将国外机构添加到进口预警名单中，以及发布警告信。
Based on these experiences, FDA has determined that RRAs are valuable oversight tools and, therefore, under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements.基于这些经验，FDA 认定远程评估是有价值的监管工具，因此，在某些情况下，能够协助 FDA 履行保护公众健康、监督受监管行业以及确保受监管产品符合 FDA 要求的使命。
With respect to section 704(a)(4) of the FD&C Act, this provision, as amended by the Food and Drug Omnibus Reform Act of 2022 (FDORA),9 gives FDA authority to request (and requires establishments to provide) any records or other information that FDA may inspect under section 704 of the FD&C Act, in advance of or in lieu of inspections of such establishments that engage in the manufacture, preparation, propagation, compounding, or processing of a drug or device,10 or a site or facility that is subject to inspection under section 704(a)(5)(C) of the FD&C Act (i.e., sites, entities, or facilities subject to bioresearch monitoring (BIMO) inspections).关于《联邦食品、药品和化妆品法案》（FD&C Act）第 704 (a)(4) 条，经 2022 年《食品药品综合改革法案》（FDORA）修订后的该条款，赋予 FDA 权力要求（并要求相关机构提供）FDA 根据《联邦食品、药品和化妆品法案》第 704 条在检查之前可能检查的任何记录或其他信息，前提是这些机构参与药品或器械的制造、制备、传播、调配或加工，或参与受《联邦食品、药品和化妆品法案》第 704 (a)(5)(C) 条检查的生物研究监测（BIMO）检查的场所或设施（即受此类检查的场所、实体或设施）。
The Agency believes that FDA’s use of both mandatory and voluntary RRAs, as applicable, for FDA- regulated products is in the interest of the public health, and the Agency is issuing this guidance to provide further transparency to interested parties about the circumstances in which the Agency may opt to use mandatory and voluntary RRAs.该机构认为，FDA 在适用情况下对受其监管的产品同时使用强制性和自愿性远程评估，符合公众健康利益，并且该机构发布本指南是为了向相关方进一步说明该机构可能选择使用强制性和自愿性远程评估的情形。
The Agency is also issuing this guidance to promote greater consistency in the manner RRAs are conducted, including by explaining processes for responding to an RRA request, and by outlining factors we use for evaluating whether an establishment has responded timely and appropriately to a mandatory request.该机构发布本指南也是为了促进远程评估实施方式的更大一致性，包括解释对远程评估请求的回应流程，以及概述用于评估机构是否及时、适当地回应强制性远程评估请求的因素。
 

Ⅲ. Questions and Answers三、问答
This section is intended to provide FDA’s current thinking regarding the requesting, conducting, and use of RRAs by FDA.本节旨在提供美国食品药品监督管理局（FDA）目前对于请求、开展和使用远程监管评估（RRA）的想法。
A.Remote Regulatory Assessment FundamentalsA. 远程监管评估基本原理
 

1.What is an RRA?1.什么是远程监管评估（RRA）？
An RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. RRAs assist in protecting human and animal health, informing regulatory decisions, and verifying certain information submitted to the Agency.远程监管评估是对受 FDA 监管的机构及其记录进行的完全远程检查，以评估其是否符合适用的 FDA 要求。远程监管评估有助于保护人类和动物健康，为监管决策提供信息，并核实提交给该机构的某些信息。
RRAs are a tool FDA may use to support regulatory decisions and oversight activities. Mandatory RRAs are those conducted under legal authorities mandating the establishment’s participation. Requests for records or other information from establishments subject to section 704(a)(4) of the FD&C Act, and requests for FSVP records under 21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C), are included among mandatory RRAs.11 RRAs that are not conducted under statutory or regulatory authorities mandating an establishment’s participation are voluntary in that an establishment can decline to participate or withdraw participation during the RRA, in which case the Agency may consider other tools for evaluating compliance with FDA requirements.远程监管评估是 FDA 可用于支持监管决策和监督活动的一种工具。强制性远程监管评估是指根据法律授权要求机构参与的评估。根据《联邦食品、药品和化妆品法案》（FD&C Act）第 704 (a)(4) 节向机构索取记录或其他信息的请求，以及根据《联邦法规汇编》（CFR）第 21 篇第 1.510 (b)(3) 和 1.512 (b)(5)(ii)(C) 节对外国供应商验证计划（FSVP）记录的请求，均属于强制性远程监管评估。在没有法定或监管授权要求机构参与远程监管评估的情况下进行的远程监管评估是自愿性的，在这种情况下，机构可以选择不参与或退出，此时 FDA 可能会考虑使用其他工具来评估其是否符合 FDA 的要求。

RRAs complement FDA’s authority to conduct inspections under section 704(a)(1) of the FD&C Act and other applicable FDA authorities. RRAs do not limit the authority of FDA to conduct inspections under section 704(a)(1) of the FD&C Act and other applicable FDA authorities.

远程监管评估补充了 FDA 根据《FD&C Act》第 704 (a)(1) 节及其他适用的 FDA 授权进行检查的权力。远程监管评估并不限制 FDA 根据《FD&C Act》第 704 (a)(1) 节及其他适用的 FDA 授权进行检查的权力。

 

2.Who may be subject to an RRA?

2.哪些对象可能接受远程监管评估？

·Mandatory RRAs·强制性远程监管评估

Mandatory RRAs include those conducted for: (1) establishments that are subject to section 704(a)(4) of the FD&C Act;12 and (2) importers, as defined in 21 CFR 1.500, that are subject to FSVP under section 805 of the FD&C Act and to the records review requirements in 21 CFR 1.510(b)(3) or 1.512(b)(5)(ii)(C) , as applicable.

强制性远程监管评估包括以下情况：(1) 受《FD&C Act》第 704 (a)(4) 节约束的机构；(2) 如《CFR》第 21 篇第 1.500 节所定义的进口商，其受《FD&C Act》第 805 节下的外国供应商验证计划（FSVP）以及《CFR》第 21 篇第 1.510 (b)(3) 或 1.512 (b)(5)(ii)(C) 节中记录审查要求的约束（如适用）。

Upon initiating a mandatory RRA, FDA intends to make clear the authorities under which the RRA is being requested.

在启动强制性远程监管评估时，FDA 打算明确提出该评估所依据的授权。

·Voluntary RRAs·自愿性远程监管评估（RRA）

If an RRA is not mandated by statute or regulation (or FDA opts against exercising its mandatory RRA authority in a certain instance), FDA may request that any establishment subject to FDA jurisdiction participate in a voluntary RRA.

如果一项RRA并非由法规或条例强制要求（或者美国食品药品监督管理局（FDA）在特定情况下选择不行使其强制RRA权力），FDA 可能会要求受其管辖的任何企业参与自愿性远程监管评估。

 

3.Are RRAs replacing other established means of obtaining information outside of inspections?

3. 远程监管评估是否正在取代检查之外的其他既定信息获取方式？

No, RRAs are not intended to limit or replace other established means of obtaining information necessary for FDA to accomplish its public health mission outside of inspections, including, among other things, applicant information request letters, registration information and updates meetings, product submissions, application assessments, or follow-up communications during outbreaks or other emergencies. Similarly, if, for example, FDA contacts an applicant to inform it that an application or other submission is missing certain information, this is not an RRA. Although these activities may be conducted remotely, the Agency does not consider these activities to be RRAs.

不，远程监管评估并非旨在限制或取代 FDA 在检查之外为实现其公共卫生使命所需的其他既定信息获取方式，其中包括但不限于申请函、监管信息请求、更新会议、产品申报、申请评估，或在疫情爆发或其他紧急情况下的跟进沟通。同样，例如，如果 FDA 联系申请人告知其某项申请或其他申报缺少某些信息，这些活动并非远程远程监管评估。尽管这些活动可能以远程方式进行，但 FDA 并不将其视为远程监管评估。

 

4. Is an RRA an inspection?

4. 远程监管评估是一种检查吗？

An RRA is not an inspection under sections 704(a)(1) or 704(a)(5) of the FD&C Act. Generally, an inspection, such as described in section 704(a)(1) of the FD&C Act, involves duly designated officers or employees of the FDA physically entering (at reasonable times and in a reasonable manner), establishments subject to regulation under the FD&C Act to determine compliance with applicable requirements.

远程监管评估并非《联邦食品、药品和化妆品法案》（FD&C Act）第 704 (a)(1) 或 704 (a)(5) 节所定义的检查。一般而言，如 FD&C 法案第 704 (a)(1) 节所述的检查，涉及 FDA 正式指定的官员或雇员（在合理时间以合理方式）实际进入受 FD&C 法案监管的企业，以确定其是否符合适用要求。

However, because remote requests for FSVP records are under the authority of section 805 of the FD&C Act and FDA’s implementing regulations,16 these record requests function as inspections in that FDA uses these record requests to evaluate a food importer’s compliance with FSVP.

然而，由于对外国供应商验证计划（FSVP）记录的远程请求是依据 FD&C 法案第 805 节以及 FDA 的实施条例授权进行的，这些记录请求在功能上等同于检查，因为 FDA 利用这些记录请求来评估食品进口商是否遵守 FSVP 要求。

5.When may FDA initiate or request to conduct an RRA?

5. FDA 何时可以发起或要求进行远程监管评估？

FDA may initiate or, in the case of a voluntary RRA, request to conduct, an RRA whenever we determine an RRA is appropriate to help fulfill the Agency’s regulatory responsibilities and to protect human and animal health. For example:

FDA 可以在确定进行远程监管评估是适当的情况下发起，或者在自愿远程监管评估的情况下要求进行远程监管评估，以履行该机构的监管职责并保护人类和动物健康。例如：

·When FDA cannot conduct an inspection due to travel limitations brought on by public health emergencies, natural disasters, or other situations making travel infeasible.·当 FDA 因公共卫生紧急情况、自然灾害或其他使出行不可行的情况导致的出行限制而无法进行检查时。
·When FDA determines that an RRA will assist us in conducting elements of establishment oversight or support regulatory decisions. Examples include preparing for an already planned inspection, following up on a consumer complaint, assisting in verifying that an establishment has completed certain corrective actions (e.g., in response to a previous inspection, or previous RRA), or supporting the review of a marketing submission.当美国食品药品监督管理局（FDA）确定远程监管评估（RRA）将有助于我们开展对企业的监管工作或支持监管决策时。例如为已计划好的检查做准备、跟进消费者投诉、协助核实企业已完成某些纠正措施（例如，针对之前的检查或之前的远程监管评估），或支持对上市申报材料的审查。

FDA intends to use a risk-based approach to determine whether to initiate or request an RRA. Factors that may be considered include, but are not limited to, establishment location, inspection history, complexity of product and process, and travel restrictions. Programs and centers within FDA may assess risk in the context of a potential RRA differently based on those and other factors.

美国食品药品监督管理局（FDA）打算采用基于风险的方法来决定是否发起或要求进行远程监管评估（RRA）。可能考虑的因素包括但不限于企业所在地、检查历史、产品和生产流程的复杂程度以及出行限制。FDA 内部的项目和中心可能会根据上述及其他因素，以不同方式评估潜在远程监管评估中的风险。

The above examples are illustrative, and the ultimate decision to initiate or request an RRA rests with FDA, as we retain discretion to use RRAs as appropriate. FDA does not accept requests to perform an RRA. When FDA determines an inspection (as opposed to an RRA) is necessary, FDA intends to perform an inspection.

以上示例仅作说明之用，最终是否发起或要求进行远程监管评估（RRA）的决定权在 FDA，因为我们保留在适当情况下使用 RRA 的自由裁量权。FDA 不接受进行 RRA 的请求。当 FDA 判定有必要进行检查（而非 RRA）时，FDA 打算进行检查。

 

6.Will FDA use RRAs during or as part of an FDA inspection of an establishment?

6.美国食品药品监督管理局（FDA）在对企业进行检查期间，会将远程监管评估（RRA）作为检查的一部分来使用吗

No, FDA does not plan to conduct RRAs and inspections17 of an establishment under sections 704(a)(1) or 704(a)(5) of the FD&C Act18 simultaneously. An RRA is conducted remotely by FDA staff, without FDA staff present at an establishment conducting an inspection. However, an RRA could precede, prompt, or be a follow-up to, an inspection. When an RRA precedes an inspection, FDA will generally conclude the RRA prior to initiating the inspection. FDA may combine any information gained from the RRA with any resulting observations from the subsequent inspection. In such circumstances, FDA would confirm any observations from the RRA during the subsequent inspection before including them on any Form FDA 483, Inspectional Observations, issued at the conclusion of the subsequent inspection.

不，美国食品药品监督管理局（FDA）不计划同时根据《联邦食品、药品和化妆品法案》（FD&C Act）第 704 (a)(1) 或 704 (a)(5) 节对企业进行远程监管评估（RRA）和检查。RRA 由 FDA 工作人员远程进行，FDA 工作人员无需亲自到企业现场开展检查。不过，RRA 可能在检查之前进行、促成检查或作为检查的后续行动。当 RRA 在检查之前进行时，FDA 通常会在启动检查前完成该 RRA。FDA 可能会将从 RRA 中获得的任何信息与后续检查中产生的任何观察结果结合起来。在这种情况下，FDA 会在后续检查结束时发布的任何《FDA 483 表格：检查观察结果》中纳入 RRA 的观察结果之前，在后续检查中确认这些观察结果。

Additionally, FDA may conduct an RRA following an inspection to conduct follow-up activities with the establishment or to assist in verifying corrective actions, if appropriate.

此外，美国食品药品监督管理局（FDA）可能在检查后开展远程监管评估（RRA），以与企业进行后续活动或在适当情况下协助核实纠正措施。

FDA may seek to conduct an RRA (e.g., livestreaming) during oversight activities independently conducted by state or foreign regulatory partners.

美国食品药品监督管理局（FDA）可能会在州或外国监管合作伙伴独立开展的监管活动期间，寻求进行远程监管评估（RRA，例如直播）。

 

7.What are the benefits of an RRA?

7.远程监管评估（RRA）的好处有哪些？

FDA, industry, and the public can all benefit from RRAs as RRAs help the Agency to meet critical public health needs. These potential benefits may include, but are not limited to:

·美国食品药品监督管理局（FDA）、行业和公众均可从远程监管评估（RRA）中受益，因为 RRA 有助于该机构满足关键的公共卫生需求。这些潜在益处可能包括但不限于：
Allowing FDA to remotely evaluate compliance of FDA-regulated products, clinical studies, and establishments, as appropriate. This may identify issues that lead establishments to promptly make corrective actions, which in addition to addressing such issues, may enhance the establishment’s preparedness for their next FDA inspection.·允许美国食品药品监督管理局（FDA）在适当情况下远程评估受其监管的产品、临床研究和企业的合规性。这可能发现促使企业及时采取纠正措施的问题，除解决这些问题外，还可能增强企业对下一次 FDA 检查的准备。
·Reducing resource expenditure. For example, when an RRA precedes an inspection under section 704(a) of the FD&C Act, FDA may not need to review as many records during the inspection, reducing the time FDA is present at the establishment.·减少资源支出。例如，当远程监管评估（RRA）先于《联邦食品、药品和化妆品法案》（FD&C Act）第 704 (a) 节规定的检查进行时，FDA 可能无需在检查期间审查过多记录，从而缩短 FDA 驻留企业的时间。
·Helping to support timely regulatory decisions (including the approval of an application or authorization for emergency use), without an inspection, when appropriate conditions are fulfilled, such as the ability to verify information in the marketing submission through use of an RRA. In such cases, the application approval, or the authorization, must still meet applicable standards.·在适当条件满足时（例如能够通过远程监管评估（RRA）核实上市申报材料中的信息），帮助支持无需进行检查即可及时做出监管决策（包括批准申请或紧急使用授权）。在此类情况下，申请批准或授权仍必须符合适用标准。

·Providing FDA additional information to incorporate into a risk-based inspection schedule, thereby helping FDA use inspectional resources more efficiently and effectively.·为美国食品药品监督管理局（FDA）提供额外信息以纳入基于风险的检查计划，从而帮助 FDA 更高效且有效地利用检查资源。协助美国食品药品监督管理局（FDA）核实纠正措施。
·Assisting FDA in verifying corrective actions.·协助美国食品药品监督管理局（FDA）核实纠正措施。

B.Remote Regulatory Assessment Expectations

B.远程监管评估要求

 

8.How may FDA request an RRA?

8.美国食品药品监督管理局（FDA）如何请求进行远程监管评估（RRA）？

FDA generally intends to use the following processes for requesting voluntary or initiating mandatory RRAs.

美国食品药品监督管理局（FDA）通常打算采用以下流程来请求自愿性或发起强制性远程监管评估（RRA）。

FDA’s request will state whether the RRA is mandatory or voluntary (and in the case of a mandatory RRA, the authorities under which it is being requested).

FDA 的请求将说明远程监管评估（RRA）是强制性还是自愿性的（如为强制性 RRA，还会说明提出请求所依据的授权）。

·In general, for voluntary RRAs

·一般而言，对于自愿性远程监管评估（RRA）

oFDA expects to contact an establishment through the establishment’s point of contact,22 by email or phone, once we determine a voluntary RRA is appropriate.

o一般来说，对于自愿性远程监管评估（RRA），美国食品药品监督管理局（FDA）预计在确定适合开展自愿性 RRA 后，通过企业的联系人以电子邮件或电话方式与企业取得联系。

oFDA may use the establishment’s registration, establishment information provided in a marketing submission, or additional information available to FDA, to identify the point of contact, authorized official, or U.S. agent.

o美国食品药品监督管理局（FDA）可能会利用企业的注册信息、上市申报材料中提供的企业信息，或 FDA 可获得的其他信息，来确定联系人、授权官员或美国代理人。

oFDA will obtain the establishment’s consent to the voluntary RRA before we begin the RRA. Where practicable, FDA generally intends to seek to obtain such consent in writing.

o美国食品药品监督管理局（FDA）将在开始自愿性远程监管评估（RRA）前获得企业对该 RRA 的同意。在可行的情况下，FDA 通常会力求以书面形式获得此类同意。

oObtaining the establishment’s consent typically includes:

o获得企业的同意通常包括：

·notifying the establishment’s point of contact of the purpose and planned scope of the RRA and of the right to refuse consent; and

·通知企业联系人远程监管评估（RRA）的目的和计划范围，以及拒绝同意的权利；

·requesting that such person confirm that the establishment voluntarily consents and has the ability to participate in the voluntary RRA requested.

·要求该人员确认企业自愿同意并具备参与所请求的自愿性远程监管评估（RRA）的能力。

oAs part of the request, FDA will typically offer the establishment the opportunity to have a discussion to inform the establishment’s decision on whether to provide consent for the voluntary RRA. Such a discussion might cover considerations, as applicable and appropriate, including:

o作为请求的一部分，FDA 通常会为企业提供讨论机会，以帮助企业决定是否同意自愿性 RRA。此类讨论可能会在适用且适当的情况下涵盖以下考量因素，包括：

·FDA’s expectations for, and any establishment limitations in participating in, the RRA.

·美国食品药品监督管理局（FDA）对远程监管评估（RRA）的预期，以及企业参与 RRA 的任何限制。

·The scheduling of virtual interviews and meetings.

·虚拟访谈和会议的时间安排。

·Technological capabilities.

·技术能力。

·The process and timeline for requesting records or other information for review.

·请求记录或其他信息以供审核的流程和时间安排。·

·How and when FDA will provide feedback to the establishment.

·美国食品药品监督管理局（FDA）将如何及何时向企业提供反馈。

·The general process and other aspects related to logistics and capabilities

·与后勤和能力相关的一般流程及其他方面。

·In general, for mandatory RRAs

·一般而言，对于强制性远程监管评估（RRA）

oFDA will initiate the request in accordance with the relevant legal authority and intends to follow any established procedures.

o美国食品药品监督管理局（FDA）将根据相关法律授权发起请求，并打算遵循任何既定程序。

oThe point of contact listed in the establishment’s registration may be used as the point of contact for the RRA request.

o企业注册中列出的联系人可作为远程监管评估（RRA）请求的联系人。

oFDA will use Form FDA 4003 to request records or other information under section 704(a)(4) of the FD&C Act.

o美国食品药品监督管理局（FDA）将根据《联邦食品、药品和化妆品法案》（FD&C Act）第 704 (a)(4) 条的规定，使用 FDA 4003 表格来请求获取记录或其他信息。

oFor pre-approval and pre-licensing inspections, there may be situations when, in advance of the inspection, records are requested of an establishment under section 704(a)(4) of the FD&C Act related to products named in multiple applications. In these situations, FDA intends to issue one Form FDA 4003 to the establishment to cover requests for records or other information for the relevant products in the applications being assessed.

o对于上市前批准和上市前许可检查，可能存在以下情况：在检查前，FDA 会根据《联邦食品、药品和化妆品法案》（FD&C Act）第 704 (a)(4) 条，向企业索要与多个申请中所列产品相关的记录。在此类情况下，FDA 拟向该企业签发一份 FDA 4003 表格，以涵盖对所评估申请中相关产品的记录或其他信息的请求。

oWhen making a request under section 704(a)(4) of the FD&C Act, FDA will provide a sufficient description of the records or other information requested, as well as our rationale for requesting such records or other information in advance of, or in lieu of, an inspection.

o当美国食品药品监督管理局（FDA）根据《联邦食品、药品和化妆品法案》（FD&C Act）第 704 (a)(4) 条提出请求时，将充分描述所请求的记录或其他信息，并说明在检查前请求此类记录或其他信息（或以此替代检查）的理由。

oUpon receipt of the requested records, we will provide confirmation of receipt to the establishment.

o收到所请求的记录后，我们将向企业提供收到确认。

 

9.What might an establishment expect to happen during an RRA?

企业在远程监管评估（RRA）过程中可能预期会发生什么？

RRAs may entail, but are not limited to, any combination of the following, depending on the type of RRA involved:

根据所涉及的远程监管评估（RRA）类型，其可能包括但不限于以下任何组合：

·FDA requests and reviews records and other information (this may include records or information from electronic systems, and source records from non-clinical and clinical studies).

·FDA要求并审核记录及其他信息（这可能包括来自电子系统的记录或信息，以及非临床和临床研究的原始记录）。

·Virtual meetings between FDA and responsible establishment personnel to review, where appropriate, the information provided to FDA, the establishment’s electronic systems, the establishment’s operations, and/or the establishment’s standard operating procedures. Interactions beyond the virtual meetings between FDA and an establishment may continue throughout an RRA.

·FDA与企业负责人员举行线上会议，在适当情况下审查向FDA提供的信息、企业的电子系统、运营情况及/或标准操作规程。FDA与企业在线上会议之外的互动可能贯穿整个远程监管评估（RRA）过程。

·Use of livestream and/or pre-recorded video, where appropriate, to examine facilities, operations, data, and other information.

·在适当情况下，使用直播和/或预录视频检查设施、操作、数据及其他信息。

FDA may review electronic systems and source records, including by screen sharing and livestream/video.27 FDA may provide updates to the establishment on observations and outstanding issues, whenever feasible, throughout the RRA. FDA expects to make reasonable and appropriate efforts to discuss observations with the management of the establishment, to minimize surprises, errors, and misunderstandings.- FDA可通过屏幕共享和直播/视频等方式审核电子系统及原始记录。在整个远程监管评估（RRA）过程中，FDA会在可行时向企业更新检查发现和未决问题。FDA将采取合理适当的措施与企业管理层讨论检查发现，以最大程度减少意外、错误和误解。
While mandatory RRAs that are conducted under relevant legal authorities involve activities detailed by such authorities, an establishment required pursuant to such authorities to participate in a mandatory RRA could agree to participate in activities beyond what is required. For instance, FDA may request that an establishment subject to a records request under section 704(a)(4) of the FD&C Act instead voluntarily participate in an RRA that accommodates review through interactive technologies such as video streaming.尽管根据相关法律授权开展的强制性远程监管评估（RRA）包含此类授权所详细规定的活动，但被该授权要求参与强制性 RRA 的企业可同意参与超出规定要求的活动。例如，FDA 可能会要求某企业（其记录请求依据《联邦食品、药品和化妆品法案》第 704 (a)(4) 条）自愿参与 RRA，通过视频流等互动技术配合审核。

10.Are there any consequences for declining to participate in an RRA?10. 拒绝参与远程监管评估（RRA）会有什么后果吗？
·Voluntary RRAs

·自愿性远程监管评估（RRA）

Because of the voluntary nature of these assessments, FDA will not take enforcement action solely based on an establishment declining a voluntary RRA.28 FDA may consider other activities necessary to exercise our oversight responsibilities regarding that establishment, such as an inspection, based on considerations such as when the establishment was last inspected, our assessment of risks, and other relevant factors. An establishment may decline to participate in a voluntary RRA, but an establishment may not opt out of an FDA inspection.

由于这些评估的自愿性质，FDA 不会仅因企业拒绝自愿性远程监管评估（RRA）而采取执法行动。FDA 可能会基于企业上次检查时间、风险评估及其他相关因素，考虑采取其他必要的监管措施（如 inspections 检查）来履行对该企业的监督职责。企业可拒绝参与自愿性 RRA，但不得拒绝 FDA 的检查。

However, if an establishment declines to participate in a voluntary RRA, FDA may not be able to assess the establishment’s activities until we exercise other oversight tools. Indeed, a voluntary RRA may be the most expedient means for FDA to assess the establishment, especially when factors prevent FDA from conducting a timely inspection. For example, in circumstances which temporarily limit FDA’s ability to conduct an inspection, such as travel restrictions, it may take FDA longer to assess an establishment or, for example, a marketing submission in which an establishment is referenced, absent an RRA, because we lack necessary information.

然而，若企业拒绝参与自愿性远程监管评估（RRA），FDA 可能无法评估其活动，除非启用其他监管工具。事实上，自愿性 RRA 可能是 FDA 评估企业的最便捷方式，尤其是当某些因素导致无法及时开展检查时。例如，在旅行限制等暂时影响 FDA 检查能力的情况下，若缺乏 RRA，FDA 可能需要更长时间来评估企业，或审核涉及该企业的上市申请，因为我们缺乏必要信息。

·Mandatory RRAs

·强制性远程监管评估（RRA）

FDA may consider the following actions, among others, as declining to participate in a mandatory RRA: failing to respond, withdrawing participation, or refusing to provide records, upon a request made in accordance with relevant legal authorities. There can be consequences for declining mandatory RRAs.

- FDA可将以下行为（包括但不限于）视为拒绝参与强制性远程监管评估（RRA）：未响应、退出参与，或在依据相关法律授权提出请求时拒绝提供记录。拒绝强制性RRA可能面临后果。

For example, an establishment that refuses a request for records or other information under section 704(a)(4) of the FD&C Act may be in violation of the FD&C Act.

例如，企业若拒绝根据《联邦食品、药品和化妆品法案》第704(a)(4)条提出的记录或其他信息请求，可能违反该法案

Similarly, if an importer refuses FDA’s written request for FSVP records under 21 CFR 1.510(b)(3) or 1.512(b)(5)(ii)(C), the importer may be in violation of section 805 of the FD&C Act, and the food offered for import by the importer may be subject to refusal under section 801(a)(3) of the FD&C Act.

- 同样，若进口商拒绝FDA根据《美国联邦法规》第21编第1.510(b)(3)或1.512(b)(5)(ii)(C)条提出的外国供应商验证计划（FSVP）记录书面请求，可能违反《联邦食品、药品和化妆品法案》第805条，且该进口商申报进口的食品可能依据该法案第801(a)(3)条被拒绝入境。

FDA intends to take appropriate action against persons32 and products that are in violation of the FD&C Act.

- FDA 拟对违反《联邦食品、药品和化妆品法案》的相关人员³²及产品采取适当行动。

 

11.Are there any technological expectations for an RRA?

11. 远程监管评估（RRA）对技术有何要求？

The technological expectations will vary depending on the type of RRA and its scope. Certain RRAs involve records requests, and the records may be submitted electronically or through other means, as applicable. Other RRAs may require additional technological capability. For example, if FDA expects that the RRA could include the use of live streaming video, FDA may inquire about hardware or internet connectivity to assess IT operability, security, and privacy controls to protect the confidentiality of the data. The quality of the remote connection (e.g., connectivity, image quality, cameras used) should be adequate for FDA to review, observe, examine, and evaluate the requested records, documents, and other information (including electronic systems). To the extent practicable, technologies employed should also allow access for remotely viewing and evaluating operations at the establishment, as appropriate (e.g., aseptic practices, equipment cleaning and set up, material weighing and dispensing, instrument set up, sampling, and testing).

技术要求将因远程监管评估（RRA）的类型和范围而异。某些 RRA 涉及记录请求，记录可根据适用情况以电子方式或其他手段提交。其他 RRA 可能需要额外技术能力。例如，若 FDA 预期 RRA 可能包含直播视频使用，将询问硬件或网络连接情况，以评估信息技术的可操作性、安全性及隐私控制措施，从而保护数据机密性。远程连接质量（如连接稳定性、图像清晰度、所用摄像头等）应足以支持 FDA 审查、观察、检查和评估所需记录、文件及其他信息（包括电子系统）。在可行范围内，所采用的技术还应允许适当远程查看和评估企业操作（如无菌操作、设备清洁与调试、物料称量与分配、仪器架设、采样及检测等）。

If an establishment is unable to support streaming video or other live virtual interactions, or if FDA determines that the streaming video or any other virtual interaction during the RRA does not permit a sufficient examination of the establishment or of a corrective action, FDA may use other available tools or may terminate the RRA and consider other actions necessary to exercise our oversight responsibilities regarding that establishment, such as an inspection.

- 若企业无法支持视频直播或其他实时线上互动，或FDA判定在远程监管评估（RRA）过程中通过视频直播或其他线上互动无法充分检查企业情况或纠正措施，FDA可能会使用其他可用工具，或终止RRA并考虑采取其他必要行动以履行对该企业的监管职责（如开展检查）。

Recommendations for sending records or other information are further explained in Question 15, below.

- 关于提交记录或其他信息的建议将在下文第15问中进一步说明。

C.Requests for Records or Other Information as Part of Remote Regulatory Assessments

C. 作为远程监管评估（RRA）一部分的记录或其他信息请求

 

12.What records or other information may FDA request as part of an RRA?

12. 作为远程监管评估（RRA）的一部分，FDA可能请求哪些记录或其他信息？

For voluntary RRAs, FDA may request records or other information appropriate to determine whether an establishment or FDA-regulated product is in compliance with applicable requirements. The records and other information will typically be similar to what FDA would request during an inspection under section 704(a)(1) of the FD&C Act.

- 对于自愿性远程监管评估（RRA），FDA可能会请求适当的记录或其他信息，以确定某企业或FDA监管的产品是否符合适用要求。这些记录和其他信息通常与FDA根据《联邦食品、药品和化妆品法案》第704(a)(1)条开展检查时可能请求的内容类似。

In the case of mandatory RRAs, the records or other information we request, and the circumstances under which we request them, will conform to the relevant legal authority. For example, under section 704(a)(4) of the FD&C Act, FDA may request any records or other information subject to inspection under section 704 of the FD&C Act. For mandatory RRAs under 21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C), FDA may request any and all records that are required to be maintained under 21 CFR Part 1, Subpart L.

- 对于强制性远程监管评估（RRA），我们所请求的记录或其他信息及其请求的情形，将符合相关法律授权。例如，根据《联邦食品、药品和化妆品法案》第704(a)(4)条，FDA可请求《联邦食品、药品和化妆品法案》第704条规定的任何可接受检查的记录或其他信息。 - 对于依据《美国联邦法规》第21编第1.510(b)(3)和1.512(b)(5)(ii)(C)条开展的强制性RRA，FDA可请求《美国联邦法规》第21编第1部分L子部分要求保存的任何及所有记录。

Examples of records or other information the Agency may request during a voluntary or mandatory RRA may include, but are not limited to:

- FDA在自愿性或强制性远程监管评估（RRA）中可能请求的记录或其他信息示例包括但不限于：

·Records of specific production lots or batches as well as product-specific information, such as periodic product reviews, product quality reports, equipment records, process validation records and reports, test results, records of product postmarket defects, or other information related to compliance with Current Good Manufacturing Practice requirements.

·特定生产批次记录及产品相关信息，例如定期产品审核、产品质量报告、设备记录、工艺验证记录与报告、检测结果、产品上市后缺陷记录，或其他与符合现行良好生产规范（CGMP）要求相关的信息。

·Certain summary records or lists of records, such as a summary of batches manufactured and their disposition, or a summary of discrepancies and investigations related to manufacturing and testing.

·特定汇总记录或记录清单，例如已生产批次及其处理情况的汇总，或与生产和检测相关的偏差及调查汇总。

·Read-only access to electronic databases or a request that an establishment walk us through information in their database or provide data queries or summary data generated by the establishment from their databases.

·电子数据库的只读访问权限，或要求企业引导我们查看其数据库中的信息，或提供企业从数据库生成的数据查询结果或汇总数据。

·Standard Operating Procedures and records generated by the establishment to document control of quality systems and/or to demonstrate compliance with FDA requirements.

·企业制定的标准操作程序（SOP）及相关记录，用于记录质量体系控制情况和/或证明符合FDA要求。

·For FSVP importers, records related to hazard analysis, the importer’s determination of appropriate supplier verification activities, performance of supplier verification activities, and/or corrective actions.

·对于外国供应商验证计划（FSVP）进口商，相关记录包括危害分析、进口商对适当供应商验证活动的判定、供应商验证活动的执行情况，及/或纠正措施记录。

·For establishments subject to BIMO inspection, records or data related to the reporting or conduct of FDA-regulated research.

·对于需接受生物研究监控（BIMO）检查的企业，与FDA监管研究的报告或实施相关的记录或数据。

Where applicable, FDA intends to take appropriate efforts to minimize the quantity of records or other information requested and may request that establishments take reasonable efforts to facilitate and expedite FDA’s collection and review of records. See Questions 14 and 15 for additional details.

在适用情况下，FDA拟采取适当措施尽量减少所请求记录或其他信息的数量，并可能要求企业合理协助以加快FDA对记录的收集和审核。更多详情见第14问和第15问。

 

13.For what purposes may FDA use the records and other information gathered during an RRA?

13.FDA可将远程监管评估（RRA）过程中收集的记录和其他信息用于哪些目的？

Depending on the scope of the RRA, the records and other information may be used by FDA for, among other things,35 the following purposes:

根据远程监管评估（RRA）的范围，FDA可将记录和其他信息用于以下目的（包括但不限于）：

·Support FDA’s assessment of pending marketing submissions, including whether to approve an application or whether to issue a response, such as a complete response letter.

·支持FDA对待审上市申报资料的评估，包括决定是否批准申请或是否发出回复（如完整回复函）。

·Determine whether an establishment or product is or is not in compliance with certain FD&C Act or Public Health Service Act requirements, and other applicable requirements.

·判定某企业或产品是否符合《联邦食品、药品和化妆品法案》《公共卫生服务法案》的特定要求及其他适用要求。

·Facilitate assessment of the need for an inspection in follow-up to a reported concern or defect.

·协助评估针对所报告问题或缺陷开展后续检查的必要性。

·Support actions such as a regulatory meeting, warning letter, import action, recall activity, or other advisory action, or to support an administrative or judicial action.

·支持监管会议、警告信、进口措施、召回行动或其他咨询行动等举措，或为行政或司法行动提供支持。

·Determine the priority of establishments for inspection, particularly a surveillance inspection.

·确定企业的检查优先级，尤其是监督检查的优先级。

 

14.If the RRA requests records or other information, what is the timeframe for submitting the records and other information to FDA?

14. 若远程监管评估（RRA）要求提供记录或其他信息，向FDA提交这些记录和信息的时间框架是怎样的？

For mandatory RRAs, FDA will request that records and other information be submitted within a timeframe consistent with the relevant legal authority.37 For voluntary RRAs, FDA may suggest timeframes to ensure the RRA is completed in a reasonable amount of time and expects establishments to work diligently to provide the requested records and other information. If necessary, establishments should communicate to the FDA point of contact as soon as possible if there is a need for an extension.The circumstances that relate to FDA’s expectations for reasonable request timeframes may include:

对于强制性远程监管评估（RRA），FDA会要求在符合相关法律授权的时间框架内提交记录和其他信息。对于自愿性RRA，FDA可能会建议时间框架以确保在合理时间内完成RRA，并期望企业积极努力提供所请求的记录和其他信息。如有必要，若企业需要延期，应尽快与FDA联系人沟通。与FDA对合理请求时间框架的预期相关的情形可能包括：

·The size, available resources, and capabilities of the establishment, including those that might exist for small businesses.

·企业的规模、可用资源及能力，包括小企业可能具备的资源与能力。

·The type, complexity, and volume of the records and other information being requested.

·所请求记录及其他信息的类型、复杂程度和数量。

·The reason for the request, such as an application action goal date, deadline, or other time- sensitive reasons.

·请求的原因，例如申请行动目标日期、截止期限或其他有时效性的原因。

·Need for translation of records.

·记录翻译的需求。

 

15.How should records or other information in response to an RRA request be provided to FDA?

15. 针对远程监管评估（RRA）请求的记录或其他信息应如何提供给FDA？

Except as provided below, requested records or other information generally should be submitted in an electronic format. FDA intends to identify and use a secure means to send requested records and information. For electronic documents, establishments should identify any limitations on external access and ensure that encrypted and password-protected files can be accessed by FDA. FDA will follow federal laws and regulations governing the confidentiality and retention of records and information submitted to the Agency (see, e.g., 5 U.S.C. 552(b)(4), and 18 U.S.C. 1905, 21 CFR Part 20).

除非另有规定，所请求的记录或其他信息通常应以电子格式提交。FDA拟确定并使用安全方式发送所请求的记录和信息。对于电子文档，企业应注明外部访问限制，并确保FDA可访问加密和受密码保护的文件。FDA将遵循管理提交至该机构的记录和信息的保密性及保存的联邦法律法规（例如，参见《美国法典》第5编第552条(b)(4)款、第18编第1905条，以及《联邦法规汇编》第21编第20部分）。

FDA recognizes that some establishments maintain documents in paper format. Requested documents maintained in paper format should be scanned as searchable Portable Document Format (PDF) files, when possible, and sent by the secure means identified by FDA. If a paper format is the only option for sending copies of records, FDA will provide the name and contact information of the FDA staff member to whom the records should be sent.

FDA认识到部分企业以纸质形式保存文件。对于以纸质形式保存的被请求文件，应尽可能扫描为可检索的PDF（便携式文档格式）文件，并通过FDA指定的安全方式发送。如果只能以纸质形式发送记录副本，FDA将提供接收记录的FDA工作人员姓名及联系方式。

FDA may request that records and other information submitted to FDA be in English or accompanied by an English translation. If translated, there should be a verification that the translation is complete and accurate, and, when applicable, should include the name, address, and a brief statement of the qualifications of the translator. Copies of the original records and information should also be included in the response, where appropriate. For certain RRAs, if a verified39 translation is not immediately available, FDA may request that the initial translation be followed up with a verified translation as soon as practicable.

FDA可能要求提交至该机构的记录及其他信息为英文或附英文翻译件。若提供翻译件，需验证翻译内容完整准确，适当时应包含翻译人员的姓名、地址及资质简要说明。必要时，回复中还应附上原始记录和信息的副本。对于特定远程监管评估（RRA），若无法立即提供经核实的翻译件，FDA可能要求在初步翻译后尽快补充经核实的翻译件。

If the records or other information are provided as part of a request under section 704(a)(4) of the FD&C Act, the records and information may be submitted in either electronic or physical form. FDA will provide confirmation upon receipt of the records.40 In general, FDA intends to maintain open communications to discuss any records received over the course of the RRA.

若记录或其他信息是根据《联邦食品、药品和化妆品法案》第704(a)(4)条的要求提供，这些记录和信息可通过电子或纸质形式提交。FDA收到记录后将予以确认。总体而言，FDA拟保持沟通渠道畅通，以讨论在远程监管评估（RRA）过程中收到的任何记录。

For RRAs under 21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C), records must be sent electronically, or through any other means that delivers the records promptly upon written request from FDA.

- 对于《联邦法规汇编》第21编第1.510(b)(3)条和第1.512(b)(5)(ii)(C)条规定的远程监管评估（RRA），记录必须以电子形式发送，或通过FDA书面请求中指定的任何其他能及时送达记录的方式提交。

D.Completion of a Remote Regulatory Assessment

D. 远程监管评估的完成

 

16.What may occur upon completion of an RRA?

16. 远程监管评估（RRA）完成后可能会发生什么？

Upon completion of an RRA, FDA may have a closeout meeting41 with the establishment’s management. At the closeout meeting, FDA may present a written list of RRA observations, if any, and describe and discuss such observations in sufficient detail to enable understanding and foster an appropriate response. For purposes of this guidance, RRA observations are defined as conditions and/or practices observed during the RRA that indicate, in the judgment of the FDA employee(s) conducting the RRA, a potential violation of the laws enforced by FDA. FDA does not intend to issue a Form FDA 483, Inspectional Observations, for an RRA. (See Question 6 for a discussion of how observations from an RRA may be confirmed during an inspection and included on a Form 483).

- 远程监管评估（RRA）完成后，FDA可能会与企业管理层召开结案会议⁴¹。在结案会议上，FDA可能会提供一份书面的RRA观察结果清单（如有），并对这些观察结果进行充分详细的描述和讨论，以确保理解并促进适当回应。在本指南中，RRA观察结果的定义为：在RRA过程中观察到的条件和/或实践，经开展RRA的FDA工作人员判断，表明可能违反FDA执行的法律。FDA不打算为RRA签发FDA 483表格（检查观察结果）。（有关RRA观察结果如何在检查中确认并列入483表格的讨论，见问题6）。

An establishment should be aware that a written list of RRA observations may be subject to a request under the Freedom of Information Act at the time the disclosure to the establishment is first made (see 21 CFR 20.101(a)) and may be made publicly available, with applicable redaction of information that is exempt from public disclosure (see, e.g., 5 U.S.C. 552(b), 18 U.S.C. 1905, 21 U.S.C. 331(j), 360j(c), 360nn(e), and 387f(c), and 21 CFR Part 20).

- 企业应当知晓，RRA观察结果的书面清单可能在首次向企业披露时被依据《信息自由法》提出公开请求（参见《联邦法规汇编》第21编第20.101(a)条），且在对依法免于公开披露的信息进行适当 redaction（删改）后可能向公众公开（例如，参见《美国法典》第5编第552条(b)款、第18编第1905条、第21编第331(j)条、第360j(c)条、第360nn(e)条、第387f(c)条，以及《联邦法规汇编》第21编第20部分）。

FDA encourages establishments to respond during a closeout meeting, and/or provide written responses to observations received at the closeout meeting within fifteen (15) U.S. business days. Responses or corrective actions submitted to FDA during that timeframe in response to the issues identified during the RRA generally will be considered before further Agency action or decision. Establishment responses are available for public disclosure as described in 21 CFR 20.103 with redaction of non-public information, as appropriate.

- FDA鼓励企业在结案会议期间作出回应，和/或在十五（15）个美国工作日内针对结案会议中收到的观察结果提供书面回复。在该时间框架内就RRA期间发现的问题提交给FDA的回复或纠正措施，通常会在FDA采取进一步行动或作出决定前得到考虑。企业回复可按《联邦法规汇编》第21编第20.103条的规定公开披露，并对非公开信息进行适当删改。

FDA’s written list of RRA observations is not a final Agency action or decision. However, information collected during an RRA may be used in support of such actions or decisions. Following an RRA, FDA may conduct an inspection or may consider other actions, as appropriate, including an enforcement action.

- FDA的RRA观察结果书面清单并非该机构的最终行动或决定。然而，RRA期间收集的信息可能用于支持此类行动或决定。在RRA之后，FDA可能会视情况进行检查或考虑其他行动，包括执法行动。

As part of the RRA process, FDA intends to ordinarily prepare a report consisting of a narrative and supporting documents that summarizes information reviewed, conditions and practices found, and RRA observations identified. In general, FDA expects to provide a written copy of the narrative portion of the RRA report43 to the establishment, following the determination that the RRA is closed (see 21 CFR 20.64(d)(3)). At that time, the RRA report and its supporting documents may also be subject to public disclosure, with applicable redactions, in response to a FOIA request.

- 作为远程监管评估（RRA）流程的一部分，FDA通常会准备一份报告，包含叙述性内容及支持性文件，总结所审查的信息、发现的条件和实践，以及确定的RRA观察结果。一般而言，FDA预计在确定RRA结案后，向企业提供RRA报告叙述部分的书面副本（参见《联邦法规汇编》第21编第20.64(d)(3)条）。届时，RRA报告及其支持性文件也可能在回应《信息自由法》（FOIA）请求时，经适当删改后予以公开披露。

 

来源：Internet

关键词： 远程监管评估 问答