CFDA Plans Reforms to Speed up Drug Reviews

The Center for Drug Evaluation at the CFDA will begin outsourcing reviews for generic drug approvals to speed up the process, said Yin Li, Deputy Director of the CFDA at a recent conference. The outsourcing will be either to China’s provincial drug agencies or independent third parties. The agency will also consider raising application fees, partly to discourage the many filings for generic drugs that already have multiple suppliers. In addition, the CDFA is being advised to allow new drugs to begin clinical trials if the agency does not approve the IND filing within 90 days. More details.... Share this with colleagues: // //