需事先批准的补充申请（Prior Approval Supplements，PAS）：对已批准的申请发生变更的补充申请，包括三种申报形式：需事先批准的补充申请Prior Approval Supplement、生效变更的补充申请 Changes Being Effected, Changes Being Effected in 30 Days、年报Annual Report；详见FDA Guidance Changes to an Approved NDA or ANDA。该MAPP仅针对需事先批准的补充申请。
参考资料：
MaPP 5310.3 on Expedited Review of PAS Supplements for NDAs and BLAs Tracks the Generic Process，2018-04-23，lachman blog
FDA MAPP 5310.3 Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes
