Mind to Market

Wednesday, April 18, 2007

Gateway to the FDA

The FDA launched a new initiative in May 2006 called the Electronics Submission Gateway (ESG) which lets pharmaceutical companies make regulatory submissions electronically. Although a modest step into the digital era, by all indications it appears to be a success. Before the ESG, drug companies were required to deliver the information in some kind of physical form, be it paper, CD-ROM, or digital tape. In the case of paper, the deliverable could be truckloads. The ESG allows for huge amounts of information, up to 100 Gb, but now it takes only minutes to upload, not days to ship.

Not only is transit time reduced, but the sender also receives a reliable acknowledgement of receipt; confirmation that the submission is in process. With the physical media there was always some question as to whether the documents made it to the right place or not.

Currently the FDA accepts submissions to CBER, CDER and CDRH. They also support receipt of Adverse Event Reporting System (AERS) reports. The next phase of the ESG will support submissions to the Center for Veterinary Medicine (CVM), Center for Food Safety and Nutrition (CFSN) and the Office of Orphan Product Designations (OOPD).

AERS reports topped 12,000 for March 2007, by far the largest percentage of submissions. These tend to be much shorter than the other submissions which have been growing steadily since launch. Users appear satisfied with the system and there are now between 150 and 200 registered users of the system.

Each of the above centers has its own set of requirements for submission, however, documents are free text which requires manual processing. Although delivery time of the documents has been reduced from days to minutes, the bulk of the regulatory work will proceed at the same pace as it had before. This can certainly be streamlined, as it has been in many other agencies, but this will require quite a significant investment, one which carries far more risk than what has been done so far.

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