Review and approval of breakthrough therapeutic drugs

On July 8, the national medical product administration issued the work procedures for the review and approval of breakthrough therapeutic drugs-Trial, the work procedures for the review and approval of the application for conditional approval of drugs -Trial, and the working procedures for the priority review and approval of drug marketing permission-Trial, which are supporting documents of the administrative measures for drug registration. The documents shall be implemented from the date of issue. The opinions on encouraging drug innovation to give priority to review and approval issued by the former State Food and Drug Administration in December 2017 shall beRead More →

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