The hike was made under Generic Drug User Fee Amendments of 2017 (GDUFA II)
Citing high workload, the US Food and Drug Administration (US FDA) has increased fee for processing Abbreviated New Drug Application (ANDA) by over $1 lakh to $1.71 lakh for the fiscal year 2018.
The hike was made under Generic Drug User Fee Amendments of 2017 (GDUFA II). The fee in FY17 was $70,480.
According to a notification on US FDA’s website, fee for Drug Master File was reduced to $47,829 for 2017-18 from $51,140 in the last fiscal.
“The FY 2018 application fee is estimated by dividing the number of FAEs that will pay the fee in FY 2018 (948) into the fee revenue amount to be derived from ANDA application fees in FY 2018 (USD 162,888,000). The result, rounded to the nearest dollar, is a fee of $171,823 per ANDA,” FDA said in a statement.
These fees are effective on October 1 2017, and will remain in effect through September 30, 2018.
The move is expected to put pressure on Indian drug-makers selling in the US market, a senior official of a city-based pharma company said.
However, the FDA has reduced the inspection fee for overseas Finished Dosage Firms to USD 2,26,087 from previous $2,72,646. Similarly, the inspection fee for overseas API (Active Pharma Ingredient) plant was fixed at $60,367 from previous $59,234.
The revenue base for GDUFA II is $493.6 million versus $323 million in the final year of GDUFA I – ANDAs are the primary workload driver of the program. GDUFA I was built on the assumption that FDA would receive 750 ANDAs per year,” the FDA said.
“Over the first four years of GDUFA I, ANDA receipts have averaged approximately 1,000 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,” it said.
The GDUFA-II will be tentatively applicable till 2022.
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