ICH guidelines of manufacturing and quality assurance of drugs and cosmetics

Abstract

The key events in the development of the generic drug industry after the Hatch -Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the US generic drug industry after the Hatch - Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re - establish a domestic generic drug industry.