Generic drugs offer a significant cost savings to patients and payors, and one reason they cost less is the path to FDA approval is shorter. Any proposed drug product that can be shown to be the same as a Reference Listed Drug (RLD) “with respect to active ingredient(s), dosage form, route of administration, strength, previously approved conditions of use, and, with certain exceptions, labeling” can be submitted under an Abbreviated New Drug Application (ANDA). This application must demonstrate the proposed drug product is bioequivalent (provides the same dose of drug when taken as directed on the label) to the RLD and its manufacturing process has the controls required to ensure its identity, strength, quality, and purity. If these criteria are met, the agency must approve the ANDA for the product. 

Not surprisingly, there are format requirements for ANDAs, including a requirement for electronic submissions. Readers will remember from my previous post there is a Common Technical Document (CTD) format developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to streamline the submission requirements across the US, Europe, and Japan (the three largest pharmaceutical markets). This format presents the quality, safety, and efficacy data on a drug product in a standardized format acceptable to the regulatory agencies of all three regions (and frequently many other regions). The eCTD is an electronic version of the CTD. The FDA issues guidance to clarify the agency’s interpretation of the CTD/eCTD format, and the latest to issue is a guidance for the content and format for ANDAs. The purpose of the guidance is to improve the quality of ANDAs, increase the number of original ANDAs submitted, and decrease the review cycles for any particular ANDA (with a target of a single cycle). 

Under this guidance, an application consists of five sections:

• Module 1 is an administrative module, consisting of agency specific information such as standard application forms, a cover sheet, and administrative information such as information about the RLD and how the proposed new drug product is similar to the RLD. Only modules 2-5 are part of the CTD; each regulatory agency has its own requirements for Module 1. 
• Module 2 provides the summaries of the chemistry, manufacturing and controls for the drug substance and drug product (the Quality Overall Summary), and the clinical data supporting bioequivalence (the Clinical Summary). Complete details on the drug product for each of these areas are included in Modules 3 (Quality) and 5 (Clinical). 
• Nonclinical Study Reports (Module 4) are generally not part of an ANDA, but this section may be needed for nonclinical reports to qualify impurities, residual solvents, leachables, or extractables. The guidance ends with a template for cover letter format.

Text Copyright © 2018 Katrina Rogers