On September 24, 2018, FDA issued final guidance on ANDA Submissions – Content and Format. The guidance outlines recommendations for the information that should be provided in each section of the common technical document (CTD) for human pharmaceutical product applications and identifies supporting guidance documents and recommendations issued by FDA to assist applicants in preparing their ANDA submission. The guidance seeks to assist ANDA applicants in improving the quality of their submissions, to increase the number of original ANDAs acknowledged for receipt upon initial submission, and to decrease the number of ANDA review cycles.

The CTD consists of five modules: Administrative Information and Prescribing Information, Summaries, Quality, Nonclinical, and Clinical. This guidance provides additional detail about the information that should be submitted in the applicable modules, sections, and subsections. Each regulatory authority that accepts the CTD uses its own Module 1, while Modules 2 through 5 are common for all regions.

FDA recommends the Summaries module include a Quality Overall Summary section, which provides an overview of the chemistry, manufacturing, and controls (CMC) section of the application and summarizes information about the drug substance (i.e., the API) and the drug product. This module should also include a Clinical Summary section, which contains summary data critical to the determination of bioequivalence (BE). The Quality module should contain all the CMC information necessary to support the application, including information supporting and verifying what was set forth in the Summaries section. This includes information, such as regional information, related to the drug substance and drug product. Regarding the Nonclinical module, this guidance suggests that ANDAs do not generally contain data typically included in this module, but if nonclinical study reports or safety assessments are submitted in support of a proposed specification, they should be included. Finally, FDA recommends the Clinical module contain all the clinical study report data needed to support the application and to demonstrate that the generic drug product is BE to the reference listed drug (RLD).

Readers are encouraged to read the final guidance, also available on FDA’s website.