New FDA regulations for submitting electronic Lot Distribution Reports (LDRs) went into effect June 10, 2015. They apply to all companies that market products in the U.S. under a Biologics License Application (BLA). Some companies must submit their first reports in Structured Product Labeling (SPL) format as early as this month, and many are finding that compliance with the new rules takes considerably more time and effort than they anticipated. They need to do much more than simply reformat their existing data to align with the FDA’s electronic system.
Early this year, three biologics companies worked with Reed Tech staff in a pilot of the new FDA LDR submissions system. They quickly realized that the new rules require them to collect and prepare for submission data that was not part of their reports previously.
For example, reports now must include information about a biologic product’s active ingredients. Active ingredient data were previously submitted to FDA as part of the drug listing required to market a product, but were not required in LDRs.
The individuals responsible for lot distribution reporting at affected companies are likely to find that the additional data being requested for multiple products are stored in various parts of their organizations, not gathered together in one convenient place. The data owners will need to locate, obtain, and format the data in accordance with the FDA’s business rules.
In many companies, LDR submissions are handled by either the quality or manufacturing group responsible for a particular product. Those groups will now need to obtain data from departments such as regulatory affairs in order to make sure that the information they submit in the report for a product matches the information that has been submitted for the drug listing.
These new data elements will become part of all reports going forward, so companies must now set up systems that will enable them to continuously collect data—and data changes—from other parts of their organizations.
The experts at Reed Tech have 10 years of experience working with SPL. After being selected by the FDA to participate in the initial pilot of the system, we have already helped to guide biologics companies through the new submission process. We came away with insights and processes that enable us to assist companies of all sizes as they prepare their new LDR submissions.