ARTICLE | Politics & Policy
China FDA says sponsors must verify data in drug applications
July 30, 2015 1:08 AM UTC
China FDA released a circular last week that imposes an Aug. 25 deadline for sponsors to inspect and validate clinical data in regulatory applications, or withdraw them without penalty.
According to Sidley Austin LLP, a backlog of 1,622 applications will be affected by the requirements, including both domestic and imported drugs. ...