In 2009 US Food and Drug Administration (FDA) guidance estimated electronic submission of facility registration information would add 4.5 hours to drugmakers workloads. Among the 203 comments the draft guidance provoked were some questioning the burden figure but the FDA is standing firm.
“FDA collaborated with members of industry and international health information data standards organisations to arrive at the current process and estimates for the burden of gathering, assembling, and submitting data”, the Agency wrote in a posting in the Federal Register .
The FDA acknowledges that some manufacturers will face a lesser or greater burden but thinks 4.5 hours is a good estimate for the time new registrations, annual updates, and other activity will take.
Firms must also prepare and maintain SOPs (standard operating procedures) for electronic filings. Preparation is a one-off, 40-hour task, after which it will take one hour a year to maintain the SOPs. The FDA thinks most companies will already have SOPs in place.
Commentators also asked the FDA for procedural clarifications and the Agency has tried to meet these requests by changing the wording of six paragraphs in its revised guidance document.
Topics clarified by the FDA include how to: communicate a change of ownership; link an importer with a particular product; and list bulk tablets that a company is importing for packaging.