CFDA clarifies penalties for clinical trial inspections
China FDA released a draft guidance offering additional clarity on consequences for non-compliance with its clinical trial data inspections, according to life sciences law firm Ropes & Gray. As part of CFDA's effort to reduce its NDA backlog, the agency introduced mandatory self-inspections of clinical trial data last year (see BioCentury Extra, July 29, 2015).
According to Ropes & Gray, the new guidance specifies that application sponsors hold legal liability for data integrity issues at study sites and CROs. It also clarifies that omission of data constitutes data forgery and says sponsors, study sites and CROs found to have forged data will face a three-year ban from refiling an application for the same product and a potential one-year ban from seeking approval of any product. Study sites engaged in data forgery will be required to immediately suspend enrollment and will be barred from performing new trials. ...