mdi ConsultantsElectronic Drug Registration and Listing (E-DRLS)
Beginning June 1, 2009, FDA intends to no longer accept drug establishment registration and drug listing information in paper format unless a waiver is granted. The establishment Registration and Drug Listing are now to be done electronically. FDA has adopted the use of the extensible markup language (XML) files in a standard SPL format for the submission of drug establishment registration and drug listing information. The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product information.
Section 510 of the Act and 21 CFR part 207, subject to certain limited exceptions, require establishment owners and operators (registrants) upon first engaging in the manufacture, preparation, propagation, compounding, or processing of drugs, (including human drugs, veterinary drugs, and biological drug products) to register their establishments and submit listing information for all drugs in commercial distribution. Registrants are also required to submit registration information for their establishments on or before December 31 of each year. At the time of registration, registrants must also submit required listing information. Additionally, registrants are required to update listing information in June and December of each year to include information for drugs that have not been previously listed. Certain changes to information for previously listed drugs must also be submitted every June and December.
Electronic Drug registration and Listing system requires code sets and codes that are used as a language recognized by a computer system. Code sets and codes used for electronic drug registration and listing are as follows:
1. Unique Ingredient Identifiers (UNII): UNII is the defined code FDA uses for ingredients/substances.
2. Data Universal Numbering System (D-U-N-S®) Number: Dun & Bradstreet assigns and maintains a database of the D-U-N-S® Numbers, which serve as unique identifiers (codes) of business entities
Information has to be submitted based on the international standards. Like the information on the country of operation has to be submitted as three character country code using the ISO 3166-1 while the telephone numbers are global telephone numbers using the Uniform Resource Identifier (URI) for Telephone Numbers RFC 3966.
Attention needs to be paid to the minute details, as the file may fail a validation, just because the information that is entered is not in proper format.
Once the submissions are ready they are to be submitted using the FDA Electronic submission gateway (FDAESG). It is very important to have an organized approach for the E DRLS so as to save significant time and resources. This is where mdi Consultants can help. We can help you in the preparation of the Electronic submissions for the establishment registration and Drug Listing.
If you do not have the resources, staff or time to set up your computer system to meet the FDA requirements for your drug registration and listing you will find that this new initiative the FDA has instituted to be a very complicated system that could be exhaustive in understanding and implementing.
Imdi has set up a system to assist our clients in entering this data with the Agency. We would be able to provide you assistance with your annual registration and drug listing. Please contact us at [email protected] for more information on the FDA’s new requirements.