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FDA issues guidance on self-identification for generics makers Posted 04/11/2016

The US Food and Drug Administration (FDA) announced on 22 September 2016 that it had published a guidance document clarifying its expectations on self-identification for generics makers.

FDA requires that generics makers self-identify so that it can calculate the user fees to be paid. Legislation to allow FDA to collect user fees from industry was passed by US Congress in September 2012 [1]. Generics drug facilities, facilities that package generic drugs and certain sites and organizations identified in a generic drug submission are required by the Generic Drug User Fee Amendments of 2012 (GDUFA) to submit, update or reconfirm identification information to FDA annually. The agency collected its first user fees as part of the GDUFA for FY 2013 [2].

The agency has issued this guidance to help generics makers meet the requirements for self-identification.

Self-Identification of Generic Drug Facilities, Sites and Organizations
Date: September 2016
www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm316672.pdf

Topics discussed in the guidance include:
• which types of generics facilities, sites and organizations are required to self-identify;
• what information is requested;
• what technical standards are to be used for electronically submitting the requested information; and
• the penalty for failing to self-identify.

Although FDA admits that there are no explicit penalties for failing to self-identify as a generic drug facility, it says that noncompliance ‘may raise significant concerns about that site’. Such failure to self-identify, says the agency, ‘may raise the likelihood of a site inspection prior to approval’. This could delay approval, as FDA states that it ‘does not expect to give priority to completion of inspections that are required simply because sites fail to comply with self-identification requirements’.

Related articles
FDA names and shames firms for failing to pay generics fees

FDA issues first warning letter for unpaid generics user fees

References
1. GaBI Online - Generics and Biosimilars Initiative. Generic drug user fees come into effect [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 4]. Available from: www.gabionline.net/Policies-Legislation/Generic-drug-user-fees-come-into-effect
2. GaBI Online - Generics and Biosimilars Initiative. Generics makers to self-identify for FY2014 generics fees [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 4]. Available from: www.gabionline.net/Policies-Legislation/Generics-makers-to-self-identify-for-FY2014-generics-fees

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Source: US FDA

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