不需要支付2018财年的设施费；应该支付2019年设施费。

 

在 GDUFA 2 期，是针对 ANDA获批后“approved”引用的设施，不是“pending or approved generic drug submission”。

但是缴费原则在GDUFA 1期都说明白了。

见指南FDA Guidance Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments 2016/11。

 

Q37. If a facility is first identified, or intended to be identified, in a pending or approved generic drug submission after the due date for payment of the facility fee for a fiscal year, is it required to pay the fee for that year? 

No. The obligation to pay the fee depends on the status of the facility on the due date, the first business day on or after October 1 of each fiscal year. In most cases the critical question will be whether there is a generic drug submission pending or approved on the due date in which the facility is referenced. 

If the facility is first identified, or intended to be identified, in a pending or approved generic drug submission after the due date, its owner will be first obligated to pay a facility fee on the next due date. However, if a facility is identified, or intended to be identified, in a pending or approved generic drug submission on the due date, and that reference to the facility is later withdrawn, or the drug submission is later withdrawn, the fee will not be refunded.

 

Q37. 若某工厂是在该财年设施费用支付缴纳期限后，首次出现在待定、或获批ANDA，其是否需要支付该年度的费用？ 

不需要。是否需要支付该年度设施费主要取决于在该交设施费的日期的状态，（一般为每财年10月1日或之后的第一个工作日）。

若某工厂在该财年设施费用支付缴纳期限后，首次出现在待定、或获批ANDA，该工厂在下一个费用支付缴纳期支付设施费用。缴纳设施费后，若引用被取消或药品申请被撤回的，费用将不被退还。