FDA publishes revised Guidance for Applicants of Marketing Authorisations for Generics

The GDUFA (Generic Drug User Fee Act), the new act on fees due for the processing of marketing authorisation applications and the inspection of production sites came into force on 9 July 2012. This serves the accelerated processing of marketing authorisation applications for generic products and the reduction of application delays, both due to the growing torrent of applications and the lack of personnel in the review departments of the FDA. Thanks to additional funding - generated by the new fees collected by the Agency - new reviewers are currently being hired.

The provisions laid down in the GDUFA needed to be clarified and the FDA published in August last year a Guidance for Industry in the Question and Answer format. On 2nd September 2013, a revised version of this guidance entitled "Generic Drug User Fee Amendments of 2012: Questions and Answers" was released, including some new questions/answers.

The Guidance addresses the following topics:

  • Fees
  • Self-identification of sites and organisations
  • Review of generic drug submissions
  • Inspections and compliance

The largest part of the document is dedicated to questions and answers about the various fees. In this part, the FDA provides detailed answers about why, who and when fees have to be raised (see also our News from 11 September 2013). Questions about the terms of payment are also clarified. Full payment of the fees (no instalment payment) must be made in U.S. Dollar, on time, and without being requested (the FDA doesn't issue any invoice). No reduced fees are available for small and medium-sized businesses.

The significant topic "self-identification" is dealt with 11 questions in total. In this part, the deadlines for self-identification for the respective following fiscal year are provided until 2016. The deadlines always begin on 1st May and end on 1st June and have to be strictly adhered to, otherwise preparations marketed in the U.S.A.  will be deemed misbranded.

The section on the review of generic drug submissions clarifies procedural issues. Among other things, one learns that certain applications for particularly urgently needed medicinal products will be reviewed in priority to get a marketing authorisation as quick as possible, e.g. products under special review programs, such as the President's Emergency Plan for AIDS Relief (PEPFAR), or products for which a nationwide shortage has been identified.

The chapter on inspections and compliance addresses 3 questions only. The answer to the first question links to the document in which the FDA commits itself to inspect foreign facilities as frequently as domestic ones according to risk-adjusted parity. In the Guidance, the link leads to this document entitled "Generic Drug User Fee Act Program Performance Goals and Procedures".

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