USA FDA’s implementation of QbD and GDUFA: A wakeup call for other regulatory agencies across the globe

Abstract

Pharmaceutical industries recently faced off some fresh challenges due to US FDA’s recommendation on implementation of refuse to receive file (RTF), quality by design (QbD), and generic drug user fee amendments (GDUFA). Those contributed a lot of changes in US generic regulatory environment. Now, major generic players are passing through a very tough time to understand these requirements. At this juncture, this paper is an attempt to understand what QbD and GDUFA are, their goodness and overall impact. By proper understanding and its ever increasing complexities, pharmaceutical companies, those intending to do business in USA, can map their regulatory strategy to move parallels with US FDA’s regulatory compliance expectations and also it can be a wakeup call for all other regulatory authorities to appreciate beauty of these initiatives. The other regulatory authorities can welcome these USFDA’s initiatives and, however, ultimately society will be benefited by having quality generic drugs at the earliest w...