By Jonathan Priest
On October 23, 2008 the FDA released its draft guidance on the new electronic submission system for drugs and establishment registrations. This guidance is proposed to take effect in June of 2009 and will impact all human and veterinarian drug manufacturers, which currently includes Homeopathic drug manufacturers. This draft guidance can be found at http://edocket.access.gpo.gov/2008/E8-25338.htm.
The draft guidance addressed the various new systems. E-list for drug submission, e-DRLS electronic Drug Registration and Listing System, and the DFRM Drug Facility Registration Module which is part of the FURLS FDA Uniform Registration and Listing System. All of these new systems will be driven in part by the XML based SPL (Structured Product Label) platform. SPL allows the electronic editing of all labeling information as well as search, review and archiving capabilities. Once edits have been made via the SPL, companies can view the FDA’s comments at http://dailymed.nlm.nih.gov/dailymed/
Summary of the guidance:
This service will replace paper versions of drugs and establishment registration using Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments Report of Private Label Distributors).
In addition to the information collected by the FDA Forms, this draft guidance addresses electronic submission of other required information as well: for registered foreign drug establishments, the name, address, and telephone number of its U.S. agent, and the name of each importer that is known.
FDA also is recommending the voluntary submission of the following additional information, when applicable:
To facilitate correspondence between foreign establishments and FDA, the e-mail address for the U.S. agent, and the telephone number(s) and e-mail address for the importer and person who imports or offers for import their drug; In providing the labeling as specified under Sec. 207.25, for manufacturers with a Web site for voluntary reporting of adverse drug reactions, the manufacturer’s telephone number and URL address that appear on the label under 21 CFR 201.57(a)(11); a site-specific D-U-N-S Number. This D-U-N-S number is a unique nine-digit sequence recognized as the universal standard for identifying and keeping track of over 100 million businesses worldwide.
Once the SPL file is created, the registrant would upload the file through the Electronic Submission Gateway (ESG). A digital certificate is needed to use the ESG. The digital certificate binds together the owner’s name and a pair of electronic keys (a public key and a private key) that can be used to encrypt and sign documents. However, a small fee of up to $20.00 is charged for the digital certificate and the registrant may need to renew the certificate not less than annually. FDA is not calculating this small fee as a cost of doing business because it is less than or equal to the biannual courier costs the registrant incurs for paper submissions.[i]
Aside from obtaining an internet certificate for the ESG, there are no capital costs or operating and maintenance costs associated with the transition from paper to electronic submissions. To create an SPL file and submit it to FDA, a registrant would need the following tools: A computer, appropriate software, access to the Internet, knowledge of terminology and standards, and access to FDA’s ESG.
Registrants (and most individuals) have computers and Internet access available for their use. If a business does not have an available computer or access to the Internet, free use of computers and Internet are usually available at public facilities, e.g., a community library; or they may request a waiver from submitting the information electronically.
Software is necessary to create a “document.” The SPL file or “document” may be created internally by a business with experience with SPL or a business may use the user-friendly software XForms, available at no cost for industry use at www.FDA.gov.
The FDA expects few exemptions due to the low burden this new system imposes upon companies. Major benefits include quicker turnaround and accuracy. Once the 2656 and 2657 registration and renewals submissions are reviewed by FDA, the information will already be in electronic form leaving little room for data entry errors and will likely speed up the turn-around time of these forms once submitted. The new system would streamline the submission of registrations normally required of Homeopathic companies. The implementation of such a process in the industry will have little operational impact due to the fact that each of the forms required are already current practice. Implementation of SOP’s related to this activity, training, and internal forms may have an initial impact. Nevertheless, this system can be implemented by the planned implementation date of June 2009 with little impact on daily operations.
[i] http://edocket.access.gpo.gov/2008/E8-25338.htm. Federal Register site accessed October 2008