FDA Electronic Submission Gateway: Impact of the Gateway
- The Gateway can have a positive impact on many existing practices:
- Time efficiency is greatly increased, and same-day delivery becomes possible.
- The number of paper copies generated for submission and archiving is dramatically reduced.
- WebTrader transmissions can replace media creation with minimal impact and with no additional resources required.
- Electronic acknowledgments of successful transmission can be received and saved.
- Shipping expenses are eliminated or greatly reduced.
- Implementing the Gateway requires some process changes:
- Some new roles (see item 3) are necessary.
- New administrative
tasks are created:
- Establishing webtrader accounts
- Obtaining digital security certificates
- The archive process must be modified.
- Technical issues must be addressed as they arise.
- The following staff and training are needed to develop a workable process with the Gateway in your company:
- Gateway specialists must be chosen and trained.
- Specific staff involved (limited training needed):
- Regulatory Operations
- Regulatory Affairs
- Information Technology
- Archive
- SOPs and working practices must be created or modified
Business Case 1: Large Pharmaceutical Company
In 2005, Company G made approximately 1500 electronic submissions that would have fit the ESG scope if it had been available. The following table compares the costs of sending 1500 submissions manually with sending 1500 submissions through the ESG. Note that the ESG carries a startup cost of approximately $40,000 (for training, security certificates, and hardware), but even with this included, it is far more cost-effective to send submissions electronically.
Table 1 - Comparative Cost Projections Based on 1500 Submissions
(traditional media submissions vs. electronic submissions)
| | Operating Costs,
Traditional Media | Operating Costs, ESG |
| Unit Cost ($) | Quantity | Total Cost ($) | Unit Cost ($) | Quantity | Total Cost ($) |
Shipping | 8.25 | 1500 | 12,375 | N/A |
| Credentials (digital certificates) | N/A | 20 | 20 | 400 |
| Resources: | |
| Hours | 63.89 | 1500 | 95,835 | 63.89 | 104 | 6644 |
| Quarter Hours | N/A | 15.97 | 1500 | 23,955 |
| Materials: | |
| CDROM | 0.15 | 1490 | 223 | N/A |
| DLT | 50.00 | 10 | 500 | N/A |
| Binders (Cover Letters) | 1.50 | 1500 | 2,250 | N/A |
| Total Cost |
$111,183.00 |
$30,999.00 |
Business Case 2: Small Pharmaceutical Company
In 2005, Company F made approximately 100 electronic submissions that would have fit the ESG scope if it had been available. The following table compares the costs of sending 100 submissions manually with sending 100 submissions through the ESG.
Table 2 - Comparative Cost Projections Based on 100 Submissions
(traditional media submissions vs. electronic submissions)
| | Operating Costs,
Traditional Media | Operating Costs, ESG |
| Unit Cost ($) | Quantity | Total Cost ($) | Unit Cost ($) | Quantity | Total Cost ($) |
| Shipping | 8.25 |
100 |
825 |
N/A |
| Credentials (digital certificates) | N/A | 20 |
1 |
20 |
| Resources: | |
| Hours | 63.89 |
100 |
6,389 | 63.89 |
7 |
447.23 |
| Quarter Hours | N/A | 15.97 |
100 |
1,597 |
| Materials: | |
| CDROM | 0.15 |
100 |
15 | N/A |
| Binders (Cover Letters) | 1.50 |
100 |
150 |
N/A |
| Total Cost |
$7,379.00 |
$2,064.23 |
|
