Gone are the days when I would have to take a train from central New Jersey to the FDA document control room in Rockville, MD so I could exchange an important Regulatory submission for an acknowledgment date stamped copy of the cover letter. Today, I can simply send submissions through the elusive “Electronic Submission Gateway,” receive my acknowledgement, and never even leave my computer.
What is the Electronic Submission Gateway (ESG)?
The FDA ESG is an electronic system that supports the receipt and processing of electronic submissions through the use of a single point of entry. 21 CFR 11.2(b) states that, “For records submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures . . .” FDA receives a variety of electronic submissions under this regulation, including biological license applications (BLAs), new drug applications (NDAs), drug master files (DMFs), investigational new drug applications (INDs), and investigational device exemptions (IDEs), as well as their associated correspondence and other types of regulatory submissions.
As the volume of Regulatory submissions continues to increase, FDA needs to automate and standardize the receipt of these submissions and their delivery to the appropriate centers. The FDA ESG automates the receipt, acknowledgment (to the applicant/sponsor), routing, and notification (to a receiving center) of electronic submissions via the Internet and meets the standards for the electronic exchange of information adopted by the American National Standards Institute (ANSI) and the National Institute of Standards and Technology (NIST).
The FDA ESG offers two secure communication options for applicants that have established gateway systems. One utilizes simple mail transfer protocol (SMTP) with secure multi-purpose internet mail extensions (S/MIME) to provide secure e-mail communication and the other supports faster information exchange and utilizes hypertext transfer protocol secure (HTTPS) to provide real-time Internet communication. The FDA ESG also offers a secure WebTrader submission option for applicants who do not have gateway systems. The WebTrader is a no-cost applet which can be downloaded from FDA and requires only a standard security certificate to provide the applicants with a secure Internet connection to FDA. The WebTrader addresses the need to expand participation in electronic submissions without costly expenditures for infrastructure upgrades and gateway systems.
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