On September 6, 2013, the China Food and Drug Administration (CFDA) announced that it has established a Registration and Information Disclosure Platform for Drug Clinical Studies (“Platform”) via the website of CFDA’s Center for Drug Evaluation (website: www.cde.org.cn).
CFDA requires all clinical studies being conducted in China and approved by CFDA, including Phase I, II, III & IV studies, bioequivalence and PK studies, to be registered on the Platform. Information required includes: detailed information about sponsors and investigators, the nature of the study, investigational drugs utilized, and enrollment and exclusion criteria for the study subjects. Each study registered on the platform will be given an identification number.
Study sponsors must make a preliminary registration on the Platform within 1 month after CFDA’s approval of the relevant studies, and complete the entire registration before the first study subject is enrolled. For those studies that were already approved by CFDA prior to this announcement, sponsors must complete the registration within 3 months from September 6. If a sponsor fails to complete a registration three years after CFDA’s approval of the studies, the approval becomes void. Sponsors are also expected to update their registrations appropriately.
The information registered on the Platform will be referenced in CFDA’s technical review and in on-site inspections, and some of the information will be available to the public. While the ostensible purpose for the Platform is to enhance transparency, this may also be a prelude to increased clinical trial site inspections by CFDA.