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Regulatory Focus™ > News Articles > China FDA Report Claims Reduced Drug Lag

China FDA Report Claims Reduced Drug Lag

Posted 04 March 2013 | By Louise Zornoza

A new report released by China's State Food and Drug Administration's (FDA) Center for Drug Evaluation shows that review and approval times for clinical trial applications for most drugs averages about 8 months per products, while oncology products fare the best at five months.

The report, released 28 February 2013, also noted that "the gap between the time-to-market of imported drugs at home and abroad also significantly shortened" relative to years prior.

The SFDA encourages Chinese clinical trial sponsors to conduct global trials and has a policy of accelerating the review and approval of such applications. The report also notes that original research conducted with imported drugs targets China's unmet medical needs and facilitates public access to the latest world-class therapies.

The agency said it utilizes the rational allocation of its review resources "to shorten the time-to-market at home and abroad for drugs with important clinical value."


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