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.

A China Food and Drug Administration announcement released on July 22 is requiring the drug applicants in over 1,600 pending product approvals to conduct self-audits of the clinical data and submit an electronic version of the reports to the CFDA’s Center for Drug and Food Inspection¹.

Health technology assessment body NICE wants Kite to collect more evidence to prove that Tecartus can cure relapsed or refractory mantle cell lymphoma. But in the meantime, it says the CAR-T therapy should be made available on the National Health Service, making UK patients among the first in the world to be offered access to the treatment.