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.
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.
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.
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.
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.
