FDA修订仿制药申请审评质量管理规范手册MAPP 5241.3
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FDA修订仿制药申请审评质量管理规范手册MAPP 5241.3
笔记 2023-10-18 美国 FDA 于 10 月 6 日发布了 MAPP 5241.3 《ANDA 评估质量管理规范》的更新版本Rev.1。此次升版主要反映了GDUFA III 中的变化,并未对 ANDA 批准的监管要求进行任何本质上的更新。 MAPP 初始版本于 2018 年 1 月发布,识林将前后两版本对比,总体变化不大,对比内容如下所示。 作为申请人,可关注以下①和②两点中对初始 ANDA 评估期间,一级评估员工作程序中新增的两点要求。两点均旨在减少等待时间,缩短评估周期。 政策部分 MAPP 5241.3 (2018.01发布) Regulatory requirements for approval exist in relevant statutory provisions and regulations but may also be addressed in guidance documents. 相关法律规定和法规中给出了批准的监管要求,但指导文件中也会提及。 MAPP 5241.3 Rev. 1 (2023.10发布) Requirements for approval are primarily specified in relevant statutory provisions and regulations, while guidance documents may provide clarity on the existing requirements or recommendations on how to meet these requirements. 批准要求主要在相关法定条款和法规中明确规定,而指南文件可能提供关于如何满足这些要求的现有要求或建议。 备注说明:澄清并明确法律法规和指南文件在对批准要求上所起指导作用的区别。 MAPP 5241.3 (2018.01发布) Primary assessors, secondary assessors, and division directors have distinct, but closely related and complementary roles and responsibilities. 一级评估员、二级评估员、和部门主任具有不同但密切相关且互补的角色和职责。 MAPP 5241.3 Rev. 1 (2023.10发布) Primary assessors, secondary assessors, branch chiefs (OPQ) and division directors (supervisors) have distinct and complementary roles and responsibilities. 一级评估员、二级评估员、分部主任(OPQ)和部门主任(主管)具有不同且互补的角色和职责。 备注说明:增加 branch chief 的角色。 职责部分 MAPP 5241.3 (2018.01发布) Primary assessors recommend whether ANDAs meet the regulatory requirements for approval. 一级评估员提议ANDA是否符合批准的监管要求。 MAPP 5241.3 Rev. 1 (2023.10发布) Primary assessors assess the ANDA, draft communications to the ANDA applicant, recommend whether the ANDA meets the regulatory requirements for approval and document the assessment. 一级评估员评估ANDA,起草给ANDA申请人的沟通信函,提议ANDA是否符合批准的监管要求,并记录评估。 备注说明:细化详述一级评估员的职责,增加“与申请人沟通”以及“记录评估”。 程序部分 — 原始ANDA MAPP 5241.3 (2018.01发布) 一级评估员: ① If primary assessors have questions about the appropriate extent of their assessment and documentation, they consult their supervisor. 如果一级评估员对他们的评估和文件记录的适当程度有疑问,他们应咨询其主管。 MAPP 5241.3 Rev. 1 (2023.10发布) 一级评估员: ① If primary assessors have questions about the appropriate extent of their assessment and documentation, they should consult the secondary assessor or the supervisor. 如果一级评估员对其评估和文件记录的适当范围有疑问,他们应咨询二级评估员或主管。 备注说明:一级评估员不仅可咨询主管,还可咨询二级评估员。 MAPP 5241.3 Rev. 1 (2023.10发布) ② Make an initial determination as to whether any potential consults will be necessary and whether there are complex issues that require prioritization or the involvement of multiple disciplines. 初步确定是否有必要进行任何潜在的咨询,以及是否存在需要优先排序或多个学科参与的复杂问题。 备注说明:增加要求:将优先事项或复杂问题提早提出,有助于缩短评估周期。 MAPP 5241.3 Rev. 1 (2023.10发布) ③ When deficiencies, information gaps or discrepancies are identified during the assessment cycle, draft information requests or deficiencies to be conveyed to the applicant in a mid-cycle letter. 当在评估周期中发现缺陷、信息差距或差异时,应在评估中期信函中向申请人发送信息请求草案或缺陷项。 备注说明:增加要求:评估中期与申请人沟通,有助于缩短评估周期。 MAPP 5241.3 (2018.01发布) Division Director的工作内容 MAPP 5241.3 Rev. 1 (2023.10发布) Branch chiefs的工作内容 Division Director的工作内容 备注说明:增加branch chief的角色并把原有的Division Director部分职责分配给branch chief。Division Director更多承担解决问题的职责。 程序部分 — 增补 MAPP 5241.3 (2018.01发布) If the amendment contains information not requested in or related to a discipline review letter or complete response letter, the primary assessor contacts the appropriate project manager. 如果增补包含学科审评函或完整回复信中未要求或与之相关的信息,则一级评估员应联系相应的项目经理。 MAPP 5241.3 Rev. 1 (2023.10发布) If the amendment contains information not requested in or related to a discipline review letter or complete response letter, FDA will act on the unsolicited amendment by the later of the goal date for the original submission/solicited amendment or the goal date assigned for the unsolicited amendment. 如果增补包含学科审评函或者完整回复函中未要求与之相关的信息,FDA将在原始申报/缺陷信回复的目标日期或主动增补的目标日期中较晚者对主动增补采取行动。 备注说明:说明了对主动增补的评估时限的制定依据。 作者:向导@大块头 识林®版权所有,未经许可不得转载 适用岗位:
工作建议:
适用范围: 文件要点:
以上仅为部分要点,请阅读原文,深入理解监管要求。 |