The Generic Drug User Fee Amendments/Act (GDUFA) is a law enacted by the government of the United States of America (USA), on 9th July 2012, under the Food and Drug Administration Safety and Innovation Act (FDASIA) to accelerate the access of safe and effective generic drugs to the public and reduce the overall cost to the industry. The act is a result of the increasing challenges in the Regulatory landscape which needs to be re-authorized every five years. According to the law, all the generic drugs manufacturers, including manufacturers of active ingredients for generic drugs, are required to submit a user fee to the FDA. The purpose of the act is three-fold: safety and effectiveness, access, transparency. In simple words, the act is to ensure that the manufacturers fulfill the quality standards of the US commerce and provide the general public with high-quality drugs at a lower cost. With the help of GDUFA, FDA can fund programs for generic drugs and its enhancement in order to increase the predictability and timeliness of the review process of generic drugs.
Types of GDUFA fees
- Drug master file (DMF) Fee – DMF fee is applicable when a DMF is referenced by a letter of authorization (LOA) for the first time.
- Abbreviated New Drug Application (ANDA) Fee – The fee applicable for applications which are submitted to the agency.
- Active Pharmaceutical Ingredient (API) Facility – The fee is applicable, if a facility has one or more APIs which are part of a generic drug that has been approved.
- Finished Dosage Form (FDF) Facility - The fee is applicable if a facility produces one or more FDFs which are part of a generic drug that has been approved.
- GDUFA Program Fee – It is an annual fee which is applicable to all the manufacturers of generic drugs.
Fees Guidelines as per GDUFA II (the latest re-authorization)
- If a firm sponsors one or more approved ANDAs, it is subject to an annual fee
- After the re-authorization, Prior Approval Supplement (PAS) fee has be eliminated
- Fees submitted by a firm is a one-time fee, despite of any number of ANDAs, i.e., sponsors do not have to pay per-ANDA fee
- If a CMO is hired by a sponsor for the manufacturing of the drug, the CMO will have to pay one-third of the annual fee
- If a sponsor falls under both the API and FDF facility, it will have to pay only the FDF fee
- Facilities outside the FDA jurisdiction will have to pay a foreign fee differential
Are you looking to market a generic drug in US? Then GDUFA might be applicable to your manufacturing unit. To know how GDUFA affects your business, reach out to us at email@example.com.