RE:RE:RE:RE:It’s been 60 days...In case nobody believed me and wished to do their own DD..
“Order 53 proposes the adoption of a negative notification system for clinical trial approvals (CTA) in place of the existing positive approval system. Order 53 proposes a mechanism for an applicant to discuss with the CDE (Centre for Drug Evaluation, group within the CFDA in charge of technical review) before filing the CTA application. If the applicant does not receive negative comments within 60 business days after the CDE accepts the CTA application, the applicant can proceed with the clinical trial directly based on the protocol submitted without the need for approval.”