CFDA Simplifies Approval Procedures for Drugs and Devices
The China Food and Drug Administration is delegating some of its approval authority for drugs to its Center for Drug Evaluation.
Starting May 1, the CDE will approve clinical trial applications for both imported and locally manufactured drugs, supplementary applications for approved drugs, and re-registrations of imported drugs.
Approval decisions must be made within 20 to 30 days after completion of the technical review of the applications. Decisions made by the CDE may be challenged through administrative review proceedings with the CFDA or administrative litigation in local courts.