China’s FDA has issued guidance on a formal investigational new drug review process that is expected to speed up approvals.
In August, the CFDA announced sweeping reforms to China’s nine-year-old drug registration rules that would reduce review time and improve the approval process. The agency’s latest guideline on IND reviews ushers in some of these reforms to provide sponsors with standardized data requirements and enhanced communication with the CFDA.
Previously, there were no specific guidelines on early-stage trials for INDs, and sponsors were often held to the approval standards of an NDA. Moreover, applicants looking to amend the clinical trial protocol for their IND had no clear regulatory guidelines on the process, according to PPD, a global contract research organization.