Moving to implement a program to speed the review and approval of dozens of drugs sold abroad but not yet approved in China, the China Food and Drug Administration (CFDA) has established special channels to approve clinically urgently listed new drugs.
The new channel will apply to medicines, selected by the CFDA, used to treat rare disease and drugs used to prevent serious life-threatening diseases. The selection procedure will call upon a panel of experts to select from new drugs approved in the United States, the European Union and Japan over the past decade to determine which may meet with approval for use in China. After drugs are selected, manufacturers will be required to demonstrate their efficacy and safety to the CFDA. Members of the public will have the opportunity to raise objections before the selected drugs are submitted to Chinese authorities for final approval.