Last year, the China Food and Drug Administration (CFDA) issued draft rules on clinical drug trials aimed at bringing its system more closely in line with international norms. Among the key changes proposed, clinical drug trials will be subject to a 60-day time limit beginning from the time the filing is formally accepted by the Center for Drug Evaluation (CDE). If the CDE does not file a rejection or query within 60 days, the applicant can assume approval and start clinical trials. Drug companies will be required to hold formal pre-filing meetings with CDE reviewers, although companies carrying out multi-region clinical trials will have the flexibility to skip directly to a filing. Meetings with CDE staff should be held to discuss trial protocols ahead of Phase II and III studies.
