Last updated: December 26, 2001
Current Operating Status of the ESTRI Gateway
1. What is the FDA's ESTRI Gateway?
2.
Technical Solution.
3. Where
do I begin to send AERS Electronic Submissions to the FDA through the ESTRI
Gateway?
4.
What are the Gateway requirements and costs?
5.
When will electronic submissions be regulated or required?
6.
Does the digital signature applied by Templar constitute a
legally binding signature under the Electronic Signature ruling?
7.
Where do I go for more information?
The Food and Drug Administration is aggressively moving towards an electronic regulatory submissions environment. A number of initiatives are currently underway, most noticeably the Electronic Regulatory Submission & Review (ERSR) program, a joint initiative between the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation Research (CBER), Office of Regulatory Affairs (ORA), and Office of Information Resources Management (OIRM) to define their strategic plans for implementing electronic submission and review systems. However, all Centers are interested in pursuing technology to allow electronic acceptance and review of regulated information.
The Electronic Standards (for the) Transmission (of) Regulatory Information (ESTRI) Gateway allows the electronic filing of regulatory information. The purpose of the ESTRI Gateway is to place a centralized, Agency-wide gateway into day-to-day operations for receiving regulatory submissions securely. The ESTRI Gateway applies a core set of open standards, applies to regulatory bodies and industry, and incorporates the International Conference on Harmonisation (ICH) M2 standardization efforts.
The benefits of electronic submissions include:
The first application of the ESTRI Gateway is the Adverse Events Reporting System (AERS), which will accept adverse event reports for CDER and CBER. The Gateway is able to receive and send data and conforms to the ICH M2 Expert Working Group standards which include transmission of an application-level acknowledgment message to be transmitted from the FDA through the Gateway upon receipt of an adverse event report. Knowledge gained from implementation and support of the ESTRI Gateway will be applied to new systems for Electronic Submissions of various types.
The "transmission loop" works in the following manner:
A conceptual overview of the FDA ESTRI Gateway is shown in Figure 1 below.
The steps to begin to send AERS electronic submissions through the Gateway are:
- RC2/RC4/DES Encryption
- S/MIME Transport over Simple Mail Transport Protocol (SMTP)
- X.509 Certificates, traded via e-mail
- Generate and receive standard Message Disposition Notification (MDN) Receipt
- Generate local notification if MDN not received (recommended)
There is currently no COTS software to perform the entire process listed
above. However, some vendors are in the process of developing software to
execute all of the above functions. Figure 2 below displays the full message
structure for an adverse event report received through the ESTRI Gateway. Note that
Templar does NOT provide the EDIFACT Interchange Envelope shown in the figure,
however Templar will check to make sure a correct envelope is present. Templar
does provide the S/MIME and SMTP functions. Guidance on the E2B format can be
found at http://www.fda.gov/cder/guidance/1861fnl.pdf
Software
FDA has purchased and installed Templar EDI software, and has an enterprise license for one server that allows unlimited trading partners for that server. FDA does not require Templar software, but does require interoperability with FDA's Templar system. Utilize any comparable software with the same functionality. Software licensing is based on number of trading partners--can purchase single to unlimited software licenses. Contact software vendors for further information.
Hardware (approximate costs)
Each Center will decide based on their internal policies and regulations. Search the FDA web site for any future Federal Register notices related to regulations or policies on this topic.
The Agency is currently reviewing its interpretation of the rule and how it applies to the digital signature created through Templar. Additional information will be posted here in the future. Check the web site http://www.fda.gov for future information on 21 CFR Part 11 Electronic Records; Electronic Signatures.
If you have further questions, or to request other information, send an e-mail to edigateway@oc.fda.gov, or e-mail or call the following contacts.
| EDI Gateway | Bill Taylor | wtaylor@oc.fda.gov | (301) 827-6504 |
Related Web Sites
| ICH E2B Format | http://www.fda.gov/cder/guidance/1861fnl.pdf |
| 21 CFR Part 11 Electronic Records; Electronic Signatures | http://www.fda.gov/ora/compliance_ref/part11/ |
| ICH M2 ICSR Specification for E2B | http://www.fda.gov/cder/m2/MANICSR2.HTM |
| ICH M2 ICSR Specification for E2BM | http://www.fda.gov/cder/m2/MANICSR21.HTM |
For information about other electronic submission initiatives, use the following contact information:
| Center | Program | Web Address | Point of Contact | Phone |
| Center for Biologics Evaluation and Research (CBER) | IND & BLA & Supplements, Marketing Applications | http://www.fda.gov/cber/guidelines.htm | Michael Fauntleroy | (301) 827-5132 or (301) 827-5101 |
| Center for Drug Evaluation and Research (CDER) | Adverse Event Reporting System (AERS) New Drug Applications (NDA) | http://www.fda.gov/cder/aerssub http://www.fda.gov/cder/regulatory/ersr |
Greg Brolund Randy Levin | (301) 827-3517 (301) 594-5411 |
| Center for Devices and Radiological Health (CDRH) | Medical Device Applications | http://www.fda.gov/cdrh/elecsub.html | Stuart Carlow | (301) 594-4754 ext. 152 |
| Center for Veterinary Medicine (CVM) | Notice of Claimed Investigational Exemption (NCIE) | http://www.fda.gov/cvm/guidance/published.htm#copies | Jerome McDonald | (301) 827-6505 |