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CVM eSubmitter Resource Center


On this page:

What is the FDA Electronic Submissions Gateway (ESG)?
How do I register for the FDA ESG?
What is the CVM Electronic Submission System (ESS)?
How do I register for the CVM ESS?
What are the standards for submitting electronic documents through the CVM ESS?
What messages will I receive after submitting an electronic document through the CVM ESS?
What are the CVM eSubmitter Programs?
How do I start using the CVM eSubmitter Programs?
What are the benefits of the CVM eSubmitter Tool?
How do I use the CVM eSubmitter Tool?
Additional Training Resources Related to ADUFA and AGDUFA Reauthorization
Collection of Establishment Information Related to Chemistry, Manufacturing, and Controls Submissions
Original Type V Veterinary Master File Webinar
CVM eSubmitter Webinar Series Resources
Need Help?


What is the FDA Electronic Submissions Gateway (ESG)?

The FDA Electronic Submissions Gateway (ESG) is the central transmission point for sending information electronically to the agency. Within that context, the FDA ESG is a conduit, or "highway", along which submissions travel to reach their final destination. It doesn’t open or review submissions; it merely routes them to the proper destination, such as to FDA’s Center for Veterinary Medicine (CVM). 

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How do I register for the FDA ESG?

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What is the CVM Electronic Submission System (ESS)?

When the FDA ESG receives a submission intended for CVM, the gateway routes it to the CVM Electronic Submission System (ESS). This system then authenticates the submission and also performs a preliminary validation of the submission (for example, it validates the document type, makes sure that the submission number is correct, and validates that the submitter is indeed the owner of the document). 

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How do I register for the CVM ESS?

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What are the standards for submitting electronic documents through the CVM ESS?

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What messages will I receive after submitting an electronic document through the CVM ESS?

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What are the CVM eSubmitter Programs?

The CVM eSubmitter programs allow users to electronically and securely submit information to the center. With the help of templates, these programs walk users through the process of building and submitting a complete and structured submission to CVM for review.  The programs contain a number of question-based tools that capture information in a structured format and provide helpful dialog boxes to reduce redundant responses. 

Users can easily download the programs for free directly from FDA’s website, and the programs require minimal configuration by users. 

There are currently three CVM eSubmitter programs for various types of submissions: 

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How do I start using the CVM eSubmitter Programs?

To use any of the above programs, you must complete these three steps:

  1. Register for the FDA Electronic Submission Gateway.
  2. Register for the CVM Electronic Submission System.
  3. Download and install the CVM eSubmitter tool

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What are the benefits of the CVM eSubmitter Tool?

The CVM eSubmitter tool has the following benefits:

  • It helps CVM more quickly respond to feedback from stakeholders on the templates, fix bugs, and make improvements.
  • It is focused strictly on the specific needs of CVM’s stakeholders when submitting electronic submissions to the center.
  • It helps CVM meet the goals set by the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act.
  • It helps CVM improve the process for reviewing regulatory information. 
  • It helps CVM integrate the eSubmitter technology with the center’s internal IT systems.

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How do I use the CVM eSubmitter Tool?

  • Getting Started with eSubmitter – This guide explains the 5 steps to get started with the CVM eSubmitter tool.
  • CVM eSubmitter Quick Guide – This guide goes over the basics of using the CVM eSubmitter tool to send electronic documents to CVM.
  • CVM eSubmitter Frequently Asked Questions – Answers to your frequently asked questions about how to use the CVM eSubmitter tool to send electronic documents to CVM.
  • Creating an Adobe Digital Signature Quick Guide – The CVM eSubmitter tool allows you to digitally sign your submissions after you create an Adobe self-sign digital ID to identify yourself. This guide shows you how to create a digital ID in Adobe Reader and Adobe Acrobat. 
  • CVM eSubmitter Preferences Quick Guide – This guide explains how you can adjust your preferences (settings) in the CVM eSubmitter tool so you can configure your submission to best suit your needs. 
  • CVM eSubmitter New Product Description and Product Book Quick Guide – This guide explains the improvements that CVM made to the eSubmitter tool to increase the consistency in how a drug product is described across submissions for the same drug product. 
  • CVM eSubmitter New File Attachment Quick Guide – This guide explains the current features for including external files in your submission.
  • CVM eSubmitter Packaging Quick Guide – This guide explains how to package your submission into a zip format to send to CVM.
  • CVM eSubmitter File Import Quick Guide – This guide details the data import capability which alleviates the task of manually performing data entry of large amounts of data that already exists elsewhere by allowing it to be imported automatically into the submission where the data import functionality is enabled.
  • CVM eSubmitter Data Book Quick Guide – This guide shows how to us the Data Book to store information from within a section of a submission and how to reuse it at a later time in sections where the data book functionality is enabled. 
  • CVM eSubmitter ADMS Book Quick Guide – This guide outlines the functions associated with viewing and managing establishment information and supply chains in the Animal Drugs and Manufacturing System, or ADMS, data books.
  • CVM eSubmitter Master File Quick Guide – This guide explains how to use the Master File book to store and reused master file information to support ADMS supply chain information.
  • CVM eSubmitter Informal Communication Quick Guide – This guide describes the steps sponsors should follow when they choose to use the informal communication process to submit certain questions to the Office of New Animal Drug Evaluation (ONADE) in eSubmitter under ‘ONADE Communication’ submission type.

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Additional Training Resources Related to ADUFA and AGDUFA Reauthorization

The 2018 reauthorization of the Animal Drug User Fee Act (ADUFA) for brand name animal drugs and the Animal Generic Drug User Fee Act (AGDUFA) for generic animal drugs mandated important changes to the submission process for drug applications. To help drug companies understand these changes, CVM developed several training resources which you can find on the New Animal Drug Application Training Resources page

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Collection of Establishment Information Related to Chemistry, Manufacturing, and Controls Submissions

Submitting Establishment Information to the Animal Drug Manufacturing System (ADMS)

CVM is pleased to announce eSubmitter updates designed to improve the collection of establishment information related to Chemistry, Manufacturing, and Controls submissions. Two new databooks (ADMS Establishment and ADMS Supply Chain) are now available to allow improved input and recall of information across multiple templates. Updated templates will be released over the next several months as follows:

Anticipated Release Date Submission Type Templates
December 17, 2021 INAD/JINAD-P-MC
February 15, 2022 ANADA/NADA-C/R-(AI, AS, AP/ CI, CS, CP)
March 15, 2022 ANADA/NADA-B/F-(AR/CR)
April 15, 2022 ANADA-A-OT
May 16, 2022 NADA-A-OT, ANADA/NADA-E-OT, C/R-(B1,NF) 
June 15, 2022 VMF-C/A-OT, C-MC, C-MR

CVM is also making a series of webinars available to walk users through the new functionality and templates:

Playlist with all webinars

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Reporting of Veterinary Drug Supply Chain Information Using the Animal Drug Manufacturing System (ADMS) eSubmitter Tool Webinar

On June 22, 2022, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) hosted a live webinar titled, “Reporting of Veterinary Drug Supply Chain Information Using the Animal Drug Manufacturing System (ADMS) eSubmitter Tool.”  In December 2021, the FDA announced an eSubmitter update intended to enable animal drug manufacturers to provide more complete facility information, particularly about the establishments that are actively used in their manufacturing processes, in order to provide supply chain data that strengthened the FDA’s ability to monitor the animal drug supply chain. This facility information is required to be submitted to the agency. This enhancement was part of the ADMS, a project funded by The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) in response to the COVID-19 public health emergency.  

The ADMS webinar explained the rationale for collection of supply chain information; included live demonstrations of users entering information into the various ADMS Books and eSubmitter templates, focused on the updated functionality; and provided a live Q&A section where users asked questions about the system and the new enhancements for sharing supply chain information.

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Original Type V Veterinary Master File Webinar

These videos will walk through each section of the Original Type V VMF template (V-A-OT) and describe the functionality and the questions associated with each screen. Disclaimer: The data included in these eSubmitter template videos are for demonstration purposes only and do not reflect guidance from the FDA on the scientific content required to answer individual questions in the V-A-OT Type V template. If you have specific questions regarding any of the questions within the template, please contact CVM at cvmesubmitter@fda.hhs.gov.

Section 1.0 General Information

Section 2.0 Product Information

Section 3.0 Buildings and Facilities

Section 4.0 Sterilization In Place

Section 5.0 Sterilization of Components Equipment by Moist Steam

Section 6.0 Sterilization of Components Equipment by Irradiation

Section 7.0 Terminal Sterilization by Moist Steam

Section 8.0 Terminal Sterilization by Irradiation

Section 9.0 Depyrogenation

Section 10.0 Environmental Monitoring

Section 11.0 Media Fills

Section 12.0 Single Use Disposables

Section 13.0 Other Information

Section 14.0 Evidence of Formal Written Procedures

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CVM eSubmitter Webinar Series Resources

Webinar 1 - FDA ESG and CVM ESS Registration Process

Webinar 2 - How to Use the CVM eSubmitter Tool

Webinar 3: Follow-up Question and Answer Session on the CVM eSubmitter Tool

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Need Help?

Email us at cvmesubmitter@fda.hhs.gov.

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