Pharmaceutical development of multisource (generic) finished pharmaceutical products – points to consider

Overview

This document addresses the pharmaceutical development of multisource FPPs containing existing active pharmaceutical ingredients (APIs) of synthetic or semisynthetic origin. For the purposes of this document an existing API is one that has been previously authorized through a finished product by a stringent regulatory authority (SRA) or, for the purposes of a national medicines regulatory authority (NMRA), that has been authorized by that NMRA or for which a monograph exists in the pharmacopoeia(s) recognized by that NMRA. APIs of biological or biotechnological origin are not covered here.

This document provides guidance on the contents of a pharmaceutical development plan for multisource pharmaceutical products for both the applicants for marketing authorizations and NMRAs. Pharmaceutical development issues depend on the API(s), the excipients, the dosage form, the manufacturing process and the container-closure system.