GDUFA II Proposed Fee Structure(GDUFA II阶段收费结构变化概述).pdf

GDUFA II Fee Structure Summary To achieve GDUFA II commitments, FDA must increase the overall capacity and capabilities of the generic drug application review program through a user fee structure that provides stable, predictable funding, is efficient in design and feasible to execute. FDA and industry agreed to jointly recommend these proposed changes for GDUFA II. I. Agreed Upon Enhancements A. Increased Funding GDUFA I was built on the assumption that FDA would receive 750 Abbreviated New Drug Applications (ANDAs) per year. ANDAs are the primary workload driver of the program. Over the first 4 years of GDUFA I, ANDA receipts have averaged approximately 1000 per year. To address the increased workload, FDA hired additional staff and is projected to spend about $430 million in the final year of GDUFA I. In order to maintain FDA’s current productivity and implement negotiated improvements, Industry and FDA agreed that user fees should total $493.6 million annually adjusted each year for inflation. B. Modifications to the User Fee Structure 1. Introduction of GDUFA Program Fees In order to maintain its generic drug review program, FDA’s user fee collections must be predictable. Whereas application volume can fluctuate from year to year, there is a relatively stable universe of generic drug facilities and ANDA sponsors. Therefore, in order to improve the predictability of the fee base and to more closely align fee responsibility with program costs and fee-paying ability, FDA and industry have agreed to shift the burden more toward annual program fees. Firms that sponsor one or more approved ANDAs will pay an annual fee. Finished Dosage Form (FDF) and Active Pharmaceutical Ingredient (API) facilities will continue