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Bickema

03/20/17 12:46 PM

#14472 RE: DewDiligence #14377

China proposes new FDA rules to speed up foreign drug approvals

http://www.fiercepharma.com/pharma-asia/china-officially-process-to-speed-up-foreign-drug-approval


Perhaps more dramatically, the new rules would allow foreign drugmakers to file for a new drug approval using data from international, multicenter trials, so long as those trials include China as a study site. Translation: No China-specific trial applications would be required for those foreign drugs.



A new tailwind for bio?