Notice from the Drug Evaluation Center of the National Medical Products Administration on the Release of Three Documents, including the Technical Requirements for Quality and Efficacy Consistency Evaluation of Chemical Drug Injection Generic Drugs (No. 2 of 2020)
Release time:2020-09-29 Browse：743次
In order to strengthen the guidance on the evaluation of the consistency of quality and efficacy of chemical drug injection generic drugs, the Drug Evaluation Center has organized the development of the "Technical Requirements for the Evaluation of Quality and Efficacy Consistency of Chemical Drug Injection Generic Drugs", "Requirements for the Application Materials of Quality and Efficacy Consistency Evaluation of Chemical Drug Injection Generic Drugs", and "Technical Requirements for the Evaluation of Quality and Efficacy Consistency of Chemical Drug Injection (Special Injection) Generic Drugs". In accordance with the requirements of the "Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Procedure for the Release of Drug Technical Guidance Principles" (Drug Administration Comprehensive Drug Administration [2020] No. 9), and after review and approval by the National Medical Products Administration,
