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NMPA Issues Announcement on Performing Consistency Evaluation of the Quality and Efficacy of Generic Chemical Injections

CCFDIE|Updated: 2020-05-14

According to the Opinions of the State Council on the Reform of the Review and Approval System for Drugs and Medical Devices (State Council [2015] No.44),Opinions of the State Council on Performing Consistency Evaluation of the Quality and Efficacy of Generic Drugs (State Council General Office [2016] No.8), Announcement on Matters Concerning the Consistency Evaluation of the Quality and Efficacy of Generic Drugs ([2018] No.102) and other relevant regulations, in order to speed up consistency evaluation of generic drugs, NMPA released an Announcement on May 14, 2020, with decisions made to perform consistency evaluation of the quality and efficacy of generic chemical injections (hereinafter referred to as the consistency evaluation of injections), relevant issues are announced as follows:

1.For marketed generic chemical injections, all the varieties that have not been approved as per the principle of consistency with the quality and efficacy of brand-name drugs must be evaluated for consistency. MAHs shall select reference formulations in accordance with the Catalogue for Reference Formulations of Generic Drugs issued by NMPA, and apply for R&D of consistency evaluation.

2. While conducting the research on the consistency evaluation of injections, MAHs shall follow relevant technical guidances such as the Technical Requirements for Consistency Evaluation of the Quality and Efficacy of Generic Chemical Injections, and the Technical Requirements for Consistency Evaluation of the Quality and Efficacy of Chemical Injections (Special Injections). While applying for consistency evaluation of injections, MAHs shall follow the Requirements for Application Dossiers for Consistency Evaluation of the Quality and Efficacy of Generic Chemical Injections to compile the application dossiers, which shall be submitted to the Center for Drug Evaluation, NMPA (hereinafter referred to as CDE) in the form of supplementary application.

3. CDE conducts technical reviews in accordance with relevant regulations and technical guidances, and initiates the testing and inspection based on the review need. CDE summarizes the review, testing and inspection and forms a comprehensive review opinion. If the comprehensive review is passed, CDE will issue an approval document for drug supplementary application.

4. Other relevant issues not covered in this Announcement shall be implemented in accordance with the relevant provisions of the Announcement on Matters Concerning the Consistency Evaluation of the Quality and Efficacy of Generic Drugs ([2017] No.100). This Announcement shall come into force as from the date of issuance.