GDUFA: FDA's new Guidance on Self-Identification of Generic Drug Manufacturers

The GDUFA (Generic Drug User Fee Amendments) is a legislative package which came into force in 2012 and entitles the US-American FDA to collect fees from generic drug manufacturers, who strive for a marketing authorisation for the American market. An annual fee has to be paid after the successful registration.

The core of the document is the obligation to "Self-Identify" for those companies that have to submit essential site-related information to the FDA. The details of this self-identification are set in a Guidance for Industry entitled "Self-Identification of Generic Drug Facilities, Sites, and Organizations" published on 22 September 2016 by the FDA in the finalised form.

The Guidance describes the following elements:

1. Which types of generic facilities, sites, and organizations are required to self-identify?

2. What information is requested?

3. What technical standards are to be used for electronically submitting the requested information?

4. What is the penalty for failing to self-identify?

Hereinafter, you will find a short summary of these four topics:

1. Companies that manufacture finished generic medicinal products for human use or the APIs for them, or both are required to self-identify as well as companies that package the finished generic drug into the primary container and label it. Besides, sites that - pursuant to a contract with the applicant (generic drug manufacturer) - repack/redistribute the finished drug from a primary container  into a different primary container are also required to submit a self-identification as well as sites that perform bioequivalence/bioavailability studies. Last but not least, the obligation to self-identify also concerns sites that are listed in the application dossier as contract laboratories for the sampling and performing of analytical testing.

2. Essential data are: the D-U-N-S number (a unique nine-digit sequence specific for each site / each distinct physical location of an entity), the "Facility Establishment Identifier, FEI" (an identifier used by the FDA for the planning and tracking of inspections) and general information with regard to the facility (company owner, type of business operation, contact data, information about the manufacture of non generic drugs).

3. The HLS standard (Health Level Seven Structured Product Labeling) requested for generic applications (ANDAs)  has to be also used for the submission of self-identification information. A detailed description of this standard can be found in the Guidance "Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Drug Listing".

4. Companies that fail to self-identify do not have to expect an explicit penalty. However, such a failure leads to two drawbacks: first, the likelihood of a site inspection by the FDA prior to approval is higher. The second drawback which is much more serious is that all the APIs or finished drugs from a manufacturer who hasn't self-identified are deemed misbranded. For the FDA, such products are not allowed for importation in the USA.

To the satisfaction of the FDA, the regulations set in the GDUFA and the provisions laid down in the new Guidance represent a major contribution to an enhanced transparency in particular of complex supply chains.

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