What Does BACPAC Stand For?

BACPAC stands for Bulk Activities Postapproval Changes

BACPAC, or Bulk Activities Postapproval Changes, refers to a regulatory framework designed to streamline the submission process for multiple post-approval changes to pharmaceuticals and biologics. This approach allows for the consolidation of various updates related to manufacturing, quality control, and other operational aspects into a single submission. By facilitating a more efficient process, BACPAC helps ensure compliance while minimizing the administrative burden on manufacturers and regulatory agencies.