China Clarifies Fast Track Approval Eligibility for Novel Biologics


The Chinese State Food and Drug Administration (“SFDA”) created a fast track review and approval process for novel drugs in its Drug Registration Rules issued in 2007. The fast track approval process is available for (1) active ingredients and their finished formulations derived from plants, animals or minerals, which have never received any market authorization in the world or newly discovered crude drugs or their finished formulations; (2) chemically active pharmaceutical ingredients and their finished formulations or biologics which have not received any market authorization in the world; (3) new drugs which are used to treat AIDS, malignant tumors, or rare diseases and have obvious clinical advantages; or (4) new drugs used to treat diseases for which no effective treatment is available. In 2009, SFDA further promulgated the administrative measures on fast track reviews and approvals to define the procedure and document requirements (“2009 Administrative Measures”). The statutory timeline for the technical review of a fast track IND filing can be reduced from 90 days to 80 days and that of a fast track NDA filing can be reduced from 150 days to 120 days.

The Drug Registration Rules and the 2009 Administrative Measures did not provide sufficient clarity on how to determine the novelty of a specific biologic drug given the structural complexity of biologics. The Center for Drug Evaluation (“CDE”), an administrative body under SFDA responsible for technical reviews during regulatory approval process, issued an opinion on March 11 to clarify the conditions for fast track approvals for novel biologics. These conditions include the following...

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