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分享丨疫情期间FDA海外检查指南

FDA 检查指南

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美国食品和药物管理局(FDA)近日发布《常见问题解答指南》,阐明在COVID-19大流行期间检查、制造和供应链变更的方法。



关于检查


目前,FDA仍然遵循上个月布署的恢复美国国内检查的举措,并将继续推迟非关键任务国外批准前检查和有因检查。(相关报道:《FDA有望在本月恢复国内检查》,2020年7月10日)。

国内检查,是基于每个个案考虑关键任务的检查;或者,在安全情况下,优先恢复国内检查。


FDA称,“关于批准前检查,FDA打算继续采用其他措施和力所能及的方法,包括:通过相互承认保密协议,要求其他可信赖的国外监管合作伙伴提供现有的检查报告;要求申请人提供信息;以及直接索取设施和其他受检实体的记录及其他信息。”


FDA还阐明如何确定是否关键任务检查,考虑因素包括,产品是否具有突破性疗法认定、再生医学高级治疗(RMAT)认定,或其诊断、治疗或预防的严重疾病是目前无适合的治疗方案的;这些要素同样都适用于FDA在国外和国内检查方面的决策。


FDA指出,有因检查和批准前检查均可为关键任务检查。一旦决定是否执行检查,将会考虑到工作人员和现场员工以及临床试验参与者和患者的安全。


在出行限制阻止FDA进行批准前检查的情况下,FDA不会无故地发出一封完整的申请回复函。


FDA表示,申请人如因担心设施的充分性而决定有必要接受检查以获得FDA的批准,FDA将尽早通知申请人。“如果在行动日期之前,尚未完成此类设施的检查,FDA通常会发出一封完整的回复函。”


FDA表示,如果机构没有充分的资料来判定某个设施,FDA会推迟对申请的行动,直到它可以执行检查为止。



制造和供应链变更


FDA同样会处理已获批准产品的制造变更和供应链变更的相关问题。


由于COVID-19导致供应链中断,制药商期望在申请中增加或更改设施,那么,可参考FDA关于该事件的既定指南。但是,对用于治疗、预防COVID-19的或目前短缺的药物生物制剂产品,FDA表示提交文件时应说明“请求优先审查”,同时提交支持请求的资料。


同样地,FDA表示,为了应对这场大流行,期望对生产工艺或设施进行变更的制药商,应参考现有规模扩大及批准后变更指南和注释,制药公司应主动联系药品评估中心和药品质量研究办公室,或生物制剂评估与研究中心内部的责任办公室,讨论非典型或灵活的提交策略。


FDA表示,“愿意考虑申请人使用较低报告类别提交某些变更的请求”,“请求”包含用于治疗、预防COVID-19或短缺的药物生物制剂的风险缓解资料。



原文:


FDA issues pandemic inspections FAQ guidance


Posted 19 August 2020 | By Michael Mezher


The US Food and Drug Administration (FDA) on Wednesday issued an immediately effective frequently asked questions guidance explaining its approach to inspections and manufacturing and supply chain changes during the coronavirus disease (COVID-19) pandemic.


Inspections


For the time being, FDA says it is still following the approach to resuming domestic inspections it laid out last month and will continue to postpone non-mission-critical foreign pre-approval and for-cause inspections. (RELATED: FDA looks to resume domestic inspections this month, Regulatory Focus 10 July 2020).

For domestic inspections, this means conducting mission-critical inspections on a case-by-case basis or, when it can be done safely, resuming domestic inspections based on priority.


“With respect to pre-approval inspections, FDA intends to continue using other tools and approaches where possible, including requesting existing inspection reports from other trusted foreign regulatory partners through mutual recognition and confidentiality agreements, requesting information from applicants, and requesting records and other information directly from facilities and other inspected entities,” FDA explains.


FDA also explains how it determines whether an inspection is mission critical. Among the factors the agency considers are whether a product has a breakthrough therapy designation or regenerative medicine advanced therapy (RMAT) designation, or is used to diagnose, treat or prevent a serious disease without an appropriate therapeutic alternative. The same factors apply to FDA’s decision-making for both foreign and domestic inspections.


FDA notes that both for-cause and pre-approval inspections can be deemed mission critical and that it will consider the safety of its staff and employees at the site, as well as clinical trial participants and patients when deciding whether to conduct an inspection.


In situations where travel restrictions prevent FDA from conducting preapproval inspections, FDA says it will not automatically issue a complete response letter for the application and that any decisions related to an application will be based on the totality of information available to the agency.


FDA says that if it determines an inspection is necessary for approval because it has concerns about the adequacy of the facility it will notify the applicant as early as possible. “If the inspection of a facility that raises such concerns has not been completed by the action date, FDA generally intends to issue a complete response letter.”


Where the agency does not have enough information to make a determination about a facility, FDA says it may defer action on an application until it can conduct an inspection.


Manufacturing and supply chain changes


FDA also addresses issues related to manufacturing and supply chain changes for already approved products.


Drugmakers looking to add or change a facility in an application due to supply chain disruptions caused by COVID-19 are instructed to refer to FDA’s established guidance on the matter. However, for drugs and biologics used to treat or prevent COVID-19 and products currently in shortage, FDA says submissions should state “Priority Review Requested” and contain information to support the request.


Similarly, FDA says drugmakers looking to make manufacturing process or facility changes in response to the pandemic should refer to existing scale up and postapproval change guidance and notes that companies should reach out to the Center for Drug Evaluation and Research’s Office of Pharmaceutical Quality or the responsible office within the Center for Biologics Evaluation and Research to discuss atypical or flexible submission strategies.


FDA says it is “willing to consider requests from applicants to submit certain changes using a lower reporting category” with adequate risk-mitigation information for drugs and biologics intended to treat or prevent COVID-19 or that are in shortage.



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