China Probe Reveals Widespread Drug Data Violations At Major Study Centers
This article was originally published in SRA
Executive Summary
Severe adverse events left unreported, critical data gone missing, subject drugs substituted to pass bioequivalent testing - these are just some of the wrongdoings disclosed by the China Food and Drug Administration in a rare report on regulatory transgressions during drug trials conducted in the country.
You may also be interested in...
2016 Review: Rapid Change Defines China Regulatory Environment
If you missed some of the many significant events in China’s policy and regulatory landscape in 2016, here is your opportunity to catch up on month-by-month developments.
China Clarifies Position on Forged Trial Data As 30 Applications Are Rejected
As more new drug applications get rejected under the China Food and Drug Administration’s drive to stamp out trial data forgery, the regulator has issued draft guidance to clarify its position on data integrity breaches.
Stay Or Exit? Global Health Players Ponder New China Trajectory
It's again the time of year when global CEOs descend on China's capital to discuss strategies. This year, however, the mood is different.