FDA Flags Minor CMC Changes That Only Require Annual Reporting

Biologics sponsors will only need to report minor post-approval manufacturing changes on an annual basis, the FDA said, in a new draft guidance.

The guidance lists examples of chemistry, manufacturing and controls changes to BLAs — including in production, quality controls, equipment, facilities or personnel — that will have minimal effect on the product.

Examples of minimal-impact changes include: reductions in overages from production batches used to compensate for manufacturing losses; changes in the location of production steps within a manufacturing area; and the manufacture of an additional product in a multiple-product area listed in an approved BLA.

Moderate or major changes may require preapproval, the agency said.