FDA proposes electronic overhaul of drug registration and listing
The FDA proposed a rule last Thursday to automate the process by which drug firms register themselves and list their products with the agency.
The Electronic Drug Registration and Listing System (EDRLS) would make the complete list of drug products marketed in the US readily accessible electronically, the FDA said.
The current list, part of which is kept on paper, has more than 120,000 drug products and contains information about specific drug formulations and manufacturers.
The data includes ingredients, dosage forms, strengths, labeling and manufacturer information.
“Having drug makers submit drug information electronically will help to keep an accurate, up-to-date inventory of drugs on the market,” said Department of Health and Human Services secretary Mike Leavitt, in a statement. “This will help us maintain more accurate information and make it easier for us to respond to drug emergencies such as recalls and drug shortages.”
Janet Woodcock, FDA deputy commissioner for operations added, “The conversion to an electronic system will make the registration and listing process more efficient and effective for industry and the agency. By providing FDA better-organized and more reliable information about drugs in the marketplace, this initiative also supports the agency’s continuing efforts to ensure the safety and quality of drugs in the US.”
The EDRLS proposal would also change the system FDA uses for assigning a drug listing number (the National Drug Code, or NDC), to marketed drugs, and would require drugs to display the NDC code on their label.
Currently, FDA maintains the repository of NDC numbers in its Drug Registration and Listing System (DRLS) and publishes an extract of this information in its NDC Directory.