Review & approval process of generic drugs in US
LEI Ji-feng
YANG Jian-hong
Abstract：The generic drug industry in US has been well developed and regulated since the generic drug legislation was established in early 1980s.The generic drugs approved by FDA are therapeutically equivalent and therefore interchangeable with the expensive brand-name drugs,which have saved a huge amount of money for the US government,employers,and patients.The systematic approach of generic drug review process has been adopted and improved by FDA with the increasing scientific understanding of pharmaceutical products and their manufacture process in the past three decades.This paper summarized the experience of the US generic drug regulation system from three aspects:stable framework of legislation,consistent review process,and comprehensive technical requirements,which may provide reference to CFDA in regard to the current reform & initiatives on generic drug regulation in China.
Keywords：generic drugreview processtherapeutic equivalencebioequivalenceinterchangeablescientific understandingFDA
Publication Date：2016-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)