CFDA releases draft of inspection guidelines

China FDA has released draft provisions on new procedures for on-site verification of clinical trial data, according to life science law firm Sidley Austin LLP. The proposed rules are part of CFDA's ongoing effort to improve the integrity of clinical data.

Sidley said CFDA's Center for Food and Drug Verification (CFDI) would provide manufacturers with 10 days notice before conducting on-site inspections to verify clinical trial data. Applicants would be allowed to voluntarily withdraw applications within, but not after, the notification window, the firm said. ...