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Regulatory Focus™ > News Articles > FDA Looks to Improve Generic Drug Submission Quality in New Guidance

FDA Looks to Improve Generic Drug Submission Quality in New Guidance

Posted 11 June 2014 | By Alexander Gaffney, RAC

FDA Looks to Improve Generic Drug Submission Quality in New Guidance

The US Food and Drug Administration (FDA) has released a new draft guidance document on the content and format of generic drug submissions using the common technical document (CTD).


Generic drug applications are regulated under Section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act), and are submitted to FDA using an Abbreviated New Drug Application (ANDA). A successful application will show that a drug is the same (as defined by FDA) as an already-approved drug or drug listed in FDA's Orange Book, often referred to a Reference-Listed Drug (RLD).

Most of these applications are submitted to FDA using the Common Technical Document (CTD), a module-based application developed by the International Conference on Harmonisation (ICH), which counts the US, EU and Japan as members. The CTD, and its digital equivalent, the eCTD, are intended to make the process of filing an application in multiple regions easier. Prior to the CTD, each region had its own application format, which required changing the information contained in the initial filing (say, in the EU) to fit the new format—an arduous process that served to slow down filings while raising drug costs. The CTD solves this by harmonizing most of the application, with a single "module" of the application containing region-specific information that cannot be harmonized.

The application collects information about a product's quality, efficacy, safety and the process used to manufacture it (QESM), and is divided into the following modules:

  • Module 1: Administrative information
  • Module 2: CTD Summaries
  • Module 3: Quality
  • Module 4: Nonclinical study reports
  • Module 5: Clinical study reports

New Guidance

FDA's new draft guidance document, ANDA Submissions — Content and Format of Abbreviated New Drug Applications, is meant to help industry increase the quality of its submissions, the agency said in a Federal Register notice. The agency's hope is that by helping industry to increase submission quality, it can help it to meet the agency's obligations under the Generic Drug User Fee Act (GDUFA), which required the agency to approve an increasing number of ANDA submissions within 10 months of submission.

What follows in the guidance is an extensive section-by-section breakdown of what the CTD application should look like, including what information should be contained within each section and what to do if certain conditions are met.

The guidance also includes a three-page appendix with a list of 31 guidance documents referenced by FDA throughout its CTD submission guidance, as well as a stock ANDA cover letter which provides a recommended format desired by FDA.

Comments on the guidance are due in 60 days.


ANDA Submissions — Content and Format of Abbreviated New Drug Applications

Federal Register Notice

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