All Generic Facilities Must Re-Register With FDA Starting Next Month, Agency Says

Posted 16 April 2013 | By Alexander GaffneyRF News Editor

The US Food and Drug Administration (FDA) has announced a self-identification reporting period for the generic pharmaceutical industry during the upcoming fiscal year (FY), part of new requirements established under the FDA Safety and Innovation Act's (FDASIA) generic drug user fee provisions.

Background

In the lead-up to the 2012 passage of FDASIA, FDA's regulators had a problem: Increasing trends in globalization had resulted in many manufacturers of generic drugs and their active pharmaceutical ingredients locating themselves beyond US borders, making it difficult for FDA to inspect facilities and, worse, determine where drug products were being manufactured in many cases.

The Generic Drug User Fee Act (GDUFA) of FDASIA, modeled off of similar user fee provisions long enacted for pharmaceuticals and medical devices, aimed to remedy this situation in part by instituting two main requirements.

The first were user fees, levied on companies with pending applications, new abbreviated new drug applications (ANDAs), manufacturing facilities, and active pharmaceutical ingredient facilities, as well as yearly maintenance fees.

The second involved registration requirements, meant to ferret out companies and manufacturing facilities not yet known to FDA to make sure that regulators could both inspect those facilities and make sure they knew which ingredients and products they manufactured.

New Timeline

Now FDA has issued a notice to the generic pharmaceutical industry, instructing it on the requirements for the coming 2014 fiscal year.

That self-identification period will fall between 1 May 2013 and 1 June 2013, during which time all facilities, sites and organizations "identified in a generic drug submissions" will be required to submit, update or reconfirm all information reported to FDA under GDUA.

While many generic pharmaceutical companies have recently identified with FDA-the last deadline was in December 2012-FDA said that those companies will need to self-identify once again for FY2014 in the coming months.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe