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5月17日，FDA更新了其疫情下检查的指南，该指南名为“COVID-19公共卫生紧急情况下的生产、供应链以及药品和生物制品检查”。该指南的初稿发布于2020年的8月，在这个14页的指南中，针对COVID-19大流行期间的检查、生产和供应链变更，FDA解释了其相关考虑。
本次更新中，FDA解释了疫情下的检查限制对药品申请将产生何种影响，并说明了此种情况下FDA在回应药企提交的申请时，在不同情形下如何签发完整回应函（complete response letter，CRL）。CRL完整描述了FDA在药企所提交的申请资料中发现的所有缺陷和缺陷之处，用于指导药企补充资料，以便使产品能够顺利获得批准。
如何影响药品申请？
Q5: How will travel restrictions resulting from the public health emergency affect my application?
问题5：突发公共卫生事件导致的出行限制将如何影响我的申请？
A5: During the COVID-19 public health emergency, FDA is using all available tools and sources of information to support regulatory decisions on applications that include sites impacted by travel restrictions due to COVID-19. For example, FDA will continue the assessment of all applications per normal assessment operations for all disciplines, where all manufacturing facilities will be evaluated using a risk-based approach consistent with existing guidelines. Similarly, the need for and selection of sites for BIMO inspections will continue to be risk-based, considering application and site-specific factors. During this interim period, FDA is using alternative tools, where available, to determine or mitigate the need for an inspection and to support the application assessment. This includes reviewing a firm’s previous compliance history, using information sharing from trusted foreign regulatory partners through mutual recognition agreements and other confidentiality agreements, requesting records “in advance of or in lieu of” facility inspections or voluntarily from facilities and sites, and conducting remote interactive evaluations where appropriate.
解答5：在COVID-19突发公共卫生事件期间，FDA正在使用所有可用的工具和信息源来支持有关申请的法规决策，其中包括受COVID-19限制出行的场所。例如，FDA将继续按照所有学科的正常评估操作对所有申请进行评估，其中将使用与现有指南一致的基于风险的方法来评估所有生产设施。同样，考虑到申请和特定场所的因素，对BIMO检查场所的需求和选择将继续基于风险。在此过渡期内，FDA将使用其它可用工具来确定或减少检查的需要、并支持申请评估。这包括审查公司以前的合规历史，使用通过互认协议和其它保密协议，使用可信赖的外国监管合作伙伴的共享信息，“在检查之前、或代替检查”而要求设施和场所提供记录（或其自愿提供），以及适当时进行远程交互评估。
CDER and CBER are continuing to evaluate applications, strategically applying a holistic approach in the decision-making process to determine if an inspection is warranted or if an inspection is no longer needed due to information gained through the use of the alternative tools mentioned above. FDA will continue to work directly with the applicants of those impacted applications.
CDER和CBER继续评估申请，在决策过程中策略性地采用整体考虑的方法，来确定是否需要进行检查，或者由于使用上述替代工具获得的信息而不再需要检查。FDA将继续与那些申请受影响的申请人直接合作。
FDA is also working directly with facilities to communicate any issues identified through a review of records or other information requested. For example, for both CDER- and CBER regulated products, interim processes have been implemented to communicate with manufacturing facilities regarding issues identified following a review of records or other information requested “in advance of or in lieu of” a preapproval or pre-license inspection. Responses from the facility regarding these issues will, as feasible, be considered before taking an action on a pending application.
FDA还直接与设施合作，通过审查记录或其它要求的信息，来沟通发现的任何问题。例如，对于CDER和CBER管制的产品，已经实施了临时流程，针对批准前或许可前检查，“在检查之前、或代替检查”而要求设施和场所提供记录和信息，FDA将对此进行审核，之后就发现的问题进行沟通。在对未决申请采取行动之前，将在可行的情况下考虑设施对这些问题的回应。
The Agency encourages applicants to be in communication with all their facilities and sites to ensure timely responses to any inquiries to support application assessment.
FDA鼓励申请人与其所有设施和场所保持联系，以确保及时响应任何询问，以支持申请评估。
会自动收到CRL吗？
Q6: If my application includes sites that cannot be inspected because of travel restrictions resulting from the public health emergency will my application automatically receive a complete response letter?
问题6：如果我的申请中包含的场所由于公共卫生紧急事件导致的出行限制而无法检查，我的申请会自动收到完整回应函（CRL）吗？
A6: No, FDA will not automatically issue a complete response (CR) letter if FDA cannot conduct an inspection because of travel restrictions resulting from the public health emergency.
解答6：不，如果由于公共卫生紧急情况导致旅行限制，FDA无法进行检查时，FDA不会自动发出完整回应函（CRL）。
Decisions regarding applications will be based on the totality of the information available to FDA, including information obtained from use of the alternative tools as described in Q5/A5.
有关申请的决定将基于FDA可获得的全部信息，包括从使用问答5中所述的替代工具获得的信息。
Based on an assessment of the product information provided in the application and based on available information about the facility or site, FDA will take one of the following actions:
基于对申请中提供的产品信息的评估，以及基于有关设施或场所的可用信息，FDA将采取以下措施之一：
批准申请
• FDA plans to approve the application if
•FDA计划在以下情况下批准该申请：
− Available information, including information obtained from the use of alternate tools, supports the adequacy of the facilities and sites named in a pending application, no other deficiencies have been identified, and the application otherwise satisfies the requirements for approval.
−可用信息，包括从使用替代工具获得的信息，支持在待决申请中指定的设施和场所的充分性，未发现其它缺陷，并且该申请还满足批准要求。
− In this case, the need for an inspection could be sufficiently mitigated by the FDA’s use of alternate tools, including a firm’s responses to outstanding issues identified from the use of alternate tools (see Q5/A5).
−在这种情况下，可以通过FDA使用替代工具来充分减少检查的需要，包括公司对使用替代工具发现的未决问题的回应（请参阅问答5）。
签发含设施或场所缺陷的CRL
• FDA plans to issue a CR letter with facility- or site-related deficiencies if
•如果满足以下条件，则FDA计划签发带有设施或现场相关缺陷的CRL：
− Available information from a prior FDA or mutual recognition agreement inspection or the use of alternate tools identifies concerns about the adequacy of a facility or site, and an inspection needed to address those concerns cannot be completed during the review cycle, or
−基于先前FDA或互认协议检查中的可用信息、或使用替代工具，确定了设施或场所的充分性存有疑问，而对此需要展开的检查在评审周期内无法完成，或者
− Responses to outstanding issues identified from requested records and other alternate sources are not sufficient to address the issues identified for a facility or site.
−对于从要求的记录和其它替代来源中发现的未决问题，回应缺陷以解决为设施或场所中所确定的问题。
− In this case, FDA intends to inform the applicant of the facility or site issues as soon as possible during the review cycle. Specifically, FDA intends to inform the applicant that an inspection will be needed before the application can be approved and that the inspection may not be conducted before the action date due to restrictions on travel.
−在这种情况下，FDA打算在评审周期内尽快将设施或场所问题通知申请人。特别是，FDA打算通知申请人，在批准申请之前将需要进行检查，并且由于出行限制，可能在行动日期之前不会进行检查。
− FDA generally intends to issue a CR letter, including a deficiency related to the facility or site, if the inspection has not been conducted by the action date.
−如果尚未在行动日期之前进行检查，则FDA通常打算签发CRL，包括与设施或场所有关的缺陷。
签发不含设施或场所缺陷的 CRL
• FDA plans to issue a CR letter without facility or site deficiencies if
•如果满足以下条件，FDA计划签发不含设施或场所缺陷的 CRL
− An inspection is necessary because there is insufficient information currently available to make a determination on the acceptability of a facility or site and other deficiencies have been identified.
–检查是必要的，因为当前没有充分的信息，来确定设施或场所的可接受性，并确定存有其它缺陷。
− In this case, FDA will not include a facility or site deficiency in the CR letter if the needed inspection cannot be completed by the action date due to travel restrictions. Rather, in the CR letter FDA will list the other deficiencies and also include a non-deficiency facility or site comment stating that an inspection will be needed to support approval of the application because there is insufficient information available to make a determination on the acceptability of a facility or site.
−在这种情况下，如果由于出行限制而无法在行动日期之前完成所需的检查，则FDA将不会在CRL中包括设施或场所的缺陷。而是，在FDA的CRL中，FDA将列出其它缺陷，并包括一个设施或场所非缺陷的评论，指出需要进行检查以支持对申请的批准，因为没有充分的信息来确定设施或场所的可接受性。
− During the review cycle, FDA intends to inform the applicant of the facility or site issues as soon as possible. Specifically, FDA intends to inform the applicant that the inspection may not be conducted before the action date due to restrictions on travel.
−在评审周期中，FDA打算尽快将设施或场所问题通知申请人。特别是，FDA打算通知申请人，由于出行限制，可能在行动日期之前不会进行检查。
推迟对申请采取行动
• FDA generally plans to defer action (i.e., miss the goal date) on an application if an inspection is necessary because there is insufficient information currently available to make a determination on the acceptability of a facility or site and other deficiencies have not been identified.
•FDA通常计划在需要检查时推迟对申请采取行动（即错过目标日期），因为目前没有充分的信息来确定设施或场所的可接受性，并且尚未发现其它缺陷。
− FDA intends to inform the applicant of the facility or site issues as soon as possible during the review cycle. Specifically, FDA intends to inform the applicant that the inspection may not be conducted before the action date due to restrictions on travel.
− FDA打算在评审周期内尽快将设施或场所问题通知申请人。特别是，FDA打算通知申请人，由于出行限制，可能在行动日期之前不会进行检查。
− If FDA defers action on the application, the project manager will contact the applicant to explain that FDA continues to monitor the public health situation, as well as travel restrictions, and that FDA will schedule the outstanding inspections once safe travel resumes. The scheduling will be based on public health need and other factors. In this case, therefore, there is no submission or communication needed by the applicant to ensure that an inspection will be scheduled to support application approval.
−如果FDA推迟对该申请采取行动，则项目经理将与申请人联系，以解释FDA将继续关注公共卫生状况以及出行限制，并且一旦安全出行恢复，FDA将安排未完成的检查。该计划将基于公共卫生需求和其它因素。因此，在这种情况下，申请人不需要提交或沟通任何信息，来确保检查得到安排以支持申请批准。
文章来源：Pharmlink
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