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Regulatory Focus™ > News Articles > FDA Releases New Electronic Submission Requirements for Biological Products

FDA Releases New Electronic Submission Requirements for Biological Products

Posted 02 September 2014 | By Alexander Gaffney, RAC

FDA Releases New Electronic Submission Requirements for Biological Products

A new guidance document issued by the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) outlines a new process of submitting lot distribution reports (LDRs) in electronic format.


As required by 21 CFR 600.81, LDRs are used to update FDA regarding the quantity of a product distributed under an approved biologics license application (BLA). Those reports are required to be submitted at least every six months, though FDA can, at its discretion, request the reports to be submitted at different intervals.

In recent years, FDA has moved away from a paper-based LDR system in favor of its electronic-based Lot Distribution Database (LDD), which the regulator has said will "improve accuracy, efficiency and timeliness."

At present, all reports must be compiled into the LDD manually in order to be used for postmarket safety surveillance purposes, FDA explained.

New Electronic Submissions

But as with most systems at FDA, LDRs are moving toward a standardized digital submission format.

In June 2014, FDA issued a final rule regarding the submission of all postmarket safety reports for drugs and biological products in electronic format, including LDRs. The rule, similar to other eSubmissions systems at the agency, calls for the use of FDA’s electronic submission gateway (ESG) and Structured Product Labeling (SPL).

Those requirements are confirmed in FDA's newest draft guidance, Electronic Submission of Lot Distribution Reports, which explains some of the finer details of exactly how companies can submit LDRs to FDA electronically.

For example, FDA calls for lot distribution files to be formatted "in the same electronic messaging standard used for drug registration and listing information and for the content of labeling for BLAs," known as the Health Level Seven (HL7) standard.

Lot distribution files should also be included under Module 3 of the electronic common technical document (Section 3.2.R, Regional Information).

The guidance contains extensive information about how to generate SPL files, instructions on how to create and validate SPL files, and how to transmit SPL files.

The guidance also notes that FDA can waive LDR submission requirements, such as when an applicant is unable to submit a file (e.g. a natural disaster).

The guidance does not apply to biological products regulated by the Center for Drug Evaluation and Research (CDER), such as monoclonal antibodies.

Expected Impact

FDA explains in the guidance that it expects the electronic submission process to ultimately help it to do its job better. "FDA is developing links between CBER’s lot distribution database and FDA’s Adverse Event Reporting System (FAERS) and Vaccine Adverse Event Reporting System (VAERS) databases," it wrote. "We anticipate that this linkage will allow for better monitoring of safety patterns by product lot."

Continued FDA:  "Although establishing electronic reporting will initially require additional effort by both FDA and regulated industry, the resultant process will increase efficiency and the accuracy and timeliness of data. The improved data file format provides a standardized and consistent presentation of lot distribution information that can be automatically transferred and validated against CBER's Regulatory Management system, which tracks licensed CBER products and manufacturers."

Comments on the guidance will be accepted by FDA through 28 November 2014.


Electronic Submission of Lot Distribution Reports (FR)

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