eCTD submission

Electronic Submission Gateway

What is ESG (Electronic Submission Gateway)?
The ESG has been setup by FDA for transfer of regulatory information in the form of eCTD, SPL, eDMF, etc..
The new Agency Gateway will enable the FDA to process regulatory information through automated mechanisms while it enables:

  • A single point of entry for receiving and processing all electronic submissions in a highly secure environment.
  • Automating current electronic processes such as the electronic acknowledgment of submissions.
  • Supporting the electronic Common Technical Document (eCTD).

How to Register for ESG?
To set up the ESG account you need to follow the following two steps

  • Test account (Used initially to test the connectivity with FDA) and
  • Production account (Required setup of test account, and after conducting few test, production account is approved and provided to the user)

How to Start?
To start with, one should apply for test account to FDA ESG, at the same time the user should also send a letter of non-repudiation agreement to FDA. The user shall receive temporary ID and Password from the FDA. This ID and Password are used to register an test account with FDA ESG. Now note that before starting with registration, please buy an digital certificate with one to three years validity and issuer and subject details duly filled in the digital certificate.

Now as per the guidelines provided by FDA ESG, user can create an test account. After creating test account, three submission are to be done, so that user can get authorisation to register for production account. This three test submission are as:

  • Connectivity Test (A 20 kb text file submission)
  • Load Test (7.5 GB submission)
  • Guidance Compliance Test

After, Successfully completing the test, a mail will be sent by FDA ESG to register for Production Account.

Author

KnetAdmin

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