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NMPA Issues the Requirements for Registration Classification and Application Dossiers of Biological Products

CCFDIE| Updated: 2020-06-30

To support the implementation of theProvisions for Drug Registration, NMPA has organized to formulate the Requirements for Registration Classification and Application Dossiers of Biological Products, which has been issued on June 29, 2020. The requirements for registration classification of biological products shall take effect as from July 1, 2020. The requirements for application dossiers of biological products shall take effect as from October 1, 2020. Before September 30, 2020, the application dossiers can be submitted according to the former requirements.