US FDA Calls on API, Generic Companies to Begin Self-Identification Process for 2014

By Zachary Brennan contact

- Last updated on GMT

US FDA: API, Generic Companies to Begin Self-ID Process for 2014

Related tags: Generic drug, Fda

The US FDA is giving generic drug facilities one month to self-identify for FY 2014 so that the agency can calculate how much to charge the companies in user fees for application reviews and inspections.

The self-identification reporting period is between May 1 and June 1, 2013. The reporting period, however, may be extended as it has in the past​.

Under the GDUFA (Generic Drug User Fee Amendments of 2012) legislation passed in 2012, companies are required to submit their information to the FDA annually. Facilities producing generic drugs and APIs, as well as “other sites and organizations that support the manufacture or approval of these products to electronically self-identify with FDA​,” the agency says.

Those sites include facilities where CROs conduct bioequivalence and bioavailability for generic firms​.

The FDA says annual self-identification is required to determine how many facilities will pay user fees and to promote global supply chain transparency. By self-identifying, the agency says it can quickly and reliably survey generic drug companies to better facilitate inspections and compliance.

This will be the second year that companies have self-identified as part of GDUFA. Last year, 1,643 companies self-identified​, leading to user fees costing domestic generic facilities more than $175,000 each, foreign generic facilities more than $190,000 each, and about $26,000 in fees for US API plants, while foreign plants paid more than $41,000 per facility.

The penalties for companies that fail to self-identify are significant and are meant to encourage companies to register, John DiLoreto, told us previously​. 

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