Generic drug application and approval process in Vietnam and Philippines

Abstract

A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use, but does not carry the brand name. Generic medicines are those where the original patent has expired and which may now be produced by manufacturers other than the original innovator company. A generic drug must contain the same active ingredients as the original brand-name formulation. The present review article describes the generic drug registration and approval process for two ASEAN countries Vietnam and Philippines.