81% Of China’s Generic Drug Applications Are Redundant
This article was originally published in PharmAsia News
Executive Summary
Chinese authorities received 2,095 generic registration applications in 2012, more than 81% of them are for generic versions of branded drugs that already have multiple approved generics.
Chinese authorities received 2,095 generic registration applications in 2012, more than 81% of them are for generic versions of branded drugs that already have multiple approved generics. This was after the then-State FDA issued a guideline prioritizing generics drug development and requiring manufacturers to base their generic drug development on products with high clinical value and medical needs. Separately, insiders also singled out extreme fragmentation and excessive production capacity as two issues facing the industry. To solve them, drug makers need to consolidate, enhance product quality and explore international market opportunities. (Click Here For More - Chinese Language)
"Over 80% Of China’s Generics Registration Applications Repeated; Pharma Sector To Face Massive Elimination" - finance.china.com.cn (4/26/2013)