In addition, the content must be submitted in a standard format, described in agency guidance on electronic filings.
Until now, the electronic submission initiatives that the FDA has undertaken have been focused on permitting, but not requiring, applicants to submit required regulatory documents in electronic format. This new regulation for the first time makes such e-submissions compulsory.
The idea is that a standard, electronic format will allow the agency to process its review of applications more quickly, speeding up the approval of drug applications It will also help the FDA to publicise more quickly changes to a product's prescribing criteria that could affect patient care.
"Using modern information technology to improve public health is no longer optional at FDA," said the agency's Commissioner Mark McClellan.
He noted that this is also an important step in the FDA's other initiatives on electronic medical records and electronic health information systems. For example, it will contribute to another project - conducted alongside other federal bodies such as the National Library of Medicine, the pharmaceutical industry, and health care information providers - to promote patient safety through electronically accessible medication information.
Paper still OK for PPIs
The agency said that the new rule will supplement the requirement that copies of the labelling and specimens of enclosures be submitted alongside a drug application. For example, copies of the patient package insert (PPI) must still be submitted to the FDA but these may still be submitted either electronically or on paper.