In 2017, the China Food and Drug Administration (CFDA) issued guidelines for the acceptance of foreign clinical data, hence in theory removing the need for local clinical trials to supplement foreign clinical data. Under those guidelines, foreign clinical study data submitted to the CFDA must meet certain standards. The foreign clinical study must follow ethical rules under the Declaration of Helsinki; it must have been carried out using good clinical practices and be open to CFDA inspections; and it also has to be authentic, reliable, and traceable, and provide complete, rather than selective, data.
Typically, foreign clinical study data includes the ethics committee’s opinions, as well as the clinical study protocol and report. If the CFDA finds any data inadequate, it can require a supplementary study to be undertaken in or outside China. Also, a supplementary in-country local clinical study can be required by the CFDA on the basis of differences in regulatory requirements, study populations, or clinical conditions.
To date, however, we have not seen any examples of foreign clinical data being accepted by China for product registration. Hopefully, this will change soon.