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The Generic Drug User Fee Amendments (GDUFA) has helped reduce the backlog of pending applications, cut the average time required to review generic drug applications towards safety and improvement in risk based inspections, according to pharmaceutical companies exporting to regulated markets.
Industry experts informed that GDUFA fee has increased the ability of the US FDA to perform critical programme functions and to reduce costs considering the reduced review timelines. The GDUFA was introduced by the US FDA to weed out non-serious pharma players who used to get production registration but were not well equipped in terms of manufacturing capacities.
Manufacturers in India used to get product registration from the US FDA free of cost. The fee came into effect from October 2, 2012 under the GDUFA. The US regulations require the exporting drug companies to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities.
The Generic Drug User Fee Act is a law designed to speed access to safe and effective generic drugs to the public, and reduce costs to industry. Up until October 2012, the law only required user fees for firms submitting new drug applications (NDAs).
Up until October 2012, the law only required user fees for firms submitting new drug applications (NDAs).
As of October 1, 2012, under GDUFA, all firms that manufacture human generic drug products, and active ingredients for human generic drug products, that are distributed in US commerce are subject to FDA user fees.
The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2023 rates for GDUFA III fees. These fees are effective on October 1, 2022, and will remain in effect through September 30, 2023.
For FY 2023, the generic drug fee rates are: ANDA ($240,582), DMF ($78,293), domestic API facility ($37,544), foreign API facility ($52,544), domestic FDF facility ($213,134), foreign FDF facility ($228,134), domestic CMO facility ($51,152), foreign CMO facility ($66,152), large size operation generic drug applicant programme ($1,620,556), medium size operation generic drug applicant programme ($648,222), and small business generic drug applicant programme ($162,056). These fees are effective on October 1, 2022, and will remain in effect through September 30, 2023.
GDUFA II provides that user fees should total $493,600,000 annually adjusted each year for inflation. For FY 2022, the generic drug fee rates are: ANDA ($225,712), DMF ($74,952), domestic API facility ($42,557) foreign API facility ($57,557), domestic FDF facility ($195,012), foreign FDF facility ($210,012), domestic CMO facility ($65,004), foreign CMO facility ($80,004), large size operation generic drug applicant program ($1,536,856), medium size operation generic drug applicant program ($614,742), and small business generic drug applicant programme ($153,686). These fees are effective on October 1, 2021, and will remain in effect through September 30, 2022.
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