An Update on Regulatory Electronic Submission

by | May 13, 2019 |

The Federal Food, Drug, and Cosmetic Act (FD&C) has enacted a law under Section 745A(a) that the regulatory submissions including investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs) should be submitted in electronic format to Food and Drug Administration (FDA). In addition to this, other reports, supplements and amendments should also be submitted in the electronic form, even if the original documents were already submitted before the enactment of electronic submissions law. The FDA has introduced Electronic Submissions Gateway (ESG) as the central point to send electronic information to FDA. The ESG does not have access to open the documents, and it only receives, acknowledges receipt and directs the submission to the appropriate FDA center providing notification of delivery to the center.

Electronic Submissions Lifecycle Management

For a market approval or renewal, an application goes through a path of initial submission including various reviews and amendments until approval. At the first time, a draft protocol is presented to FDA for review, and it is called an original document. After the review from the FDA, this document is edited as per FDA comments, and a new version is submitted again. All the amended submissions are based on the previous submissions except the original one. This whole process is referred to as the lifecycle of electronic submission. FDA provides two options for review, i.e, Current View and Cumulative View: Current View shows only the current version of the document and does not show documents that have been deleted or replaced, and the Cumulative View shows the full lifecycle including all the versions that existed before the current version.

FDA Data Validation Standards

FDA acknowledges electronic entries in which the study data are provided per standards, terminologies, and formats of the FDA Data Standards Catalog. All the requirements needed for the submission of clinical as well as nonclinical studies are per FD&C act.

The validation and review of the study data are done at regular intervals throughout the submission process. Data validation is done after the generation of receipt of electronic submission. Two kinds of rules are considered for data validation:

  • Business rules: these rules guarantee that the investigation information is consistent, valuable, and will strengthen the significant analysis.
  • Validator rules: these rules are utilized by the FDA to ensure that the data are according to the standards and enhance review, and analysis.

Electronic Submission Challenges and Opportunities

There are a number of opportunities for sponsors with electronic submissions, but there are certain challenges too.

Opportunities include diminished operational cost for paper‐related assignments, decrease in ecological footprint and improved industry associations. While electronic submission is now required in academic environments, it is expected that that sponsor, institutions, investigators, and FDA could profit by eCTD capacity inside the scholarly research venture.

There are certain challenges with the electronic submission process and the main challenges include new medical writing practices, staff training and increasing technological innovation costs.

In conclusion, electronic submission in compliance with FDA guidelines decreases review time and improves the chances of approval. Therefore, it is significant that both the sponsors and related authorities such as clinical research organizations must know the standard guidelines of electronic submissions. All the users should check the current versions of submission guidance before any submissions as FDA updates its guidelines from time to time.