FDA Launches E-Filing Initiative

The FDA is launching a pilot program to allow manufacturers to electronically file drug establishment registration and drug listing information, such as ingredients, labeling, and manufacturing information. Electronic filing will be available for the first time for all manufacturers of human drug products, including over the counter and biological drug products, as well as veterinary drugs.  

A draft guidance and accompanying technical documents was issued on July 10, 2008, that explains how companies can file this information electronically. This system will make it easier for companies to meet their registration and listing requirements and it will help the FDA maintain more accurate information so it can better identify possible safety issues and respond to drug emergencies such as recalls and drug shortages.

The FDA is encouraging companies to begin submitting registration and listing information in electronic format as part of the voluntary pilot period. The FDA intends to end the transition period and only accept electronic files for drug establishment registration and drug listing beginning June 1, 2009.

The draft guidance is one in a series of guidance documents intended to assist companies making regulatory submissions to FDA in electronic format.

Draft guidance (PDF)

Related technical documents