SFDA To Review Qualifications Of Clinical Drug Trial Organizations
This article was originally published in PharmAsia News
Executive Summary
China's State FDA recently circulated a notice asking all healthcare institutions with clinical drug trial qualifications to apply for local provincial health administration qualification confirmation if they want to continue conducting clinical trials after certification expires. The circular requests clinical trial organizations that received SFDA approval before Jan. 1, 2007 to submit their review applications by June 10 for consideration by SFDA and the Ministry of Health in 2009. Organizations that received approval after that date should reapply six months before the expiry date. Companies that do not submit applications for review within the stipulated time frame will lose their clinical trial qualifications. During the review period, new applications for joining the clinical trial sector will not be accepted. (Click here for more - Chinese Language)