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NMPA Issues the Announcement on Three Documents Including the Working Procedures for Review of Breakthrough Therapy Drugs (Interim)

CCFDIE|Updated: 2020-07-07

     

In order to cooperate with the implementation of the Provisions for Drug Registration, NMPA has organized to formulate the Working Procedures for Review of Breakthrough Therapy Drugs (Interim), Working Procedures for Review and Approval of Applications for Conditional Approval of Drug Marketing (Interim) and Working Procedures for Priority Review and Approval of Drug Marketing Authorization (Interim), which issued on July 7, 2020.

This Announcement shall be implemented as of the date of issuance. The Opinions on Encouraging Pharmaceutical Innovation via Priority Review & Approval issued by CFDA in December 2017 shall be abolished simultaneously.