China’s National Medical Products Administration (NMPA) announced regulatory improvements to the generic injections’ quality and efficacy consistency evaluation in May 2020.
The NMPA announcement was made as a result of opinions released by the Chinese ‘State Council on the reform of the review and approval system for drugs and medicinal devices’, and the ‘State Council on performing consistency evaluation of the quality and efficacy of generic drugs’, regarding generic drug quality and efficacy consistency evaluation. This action is a direct result of China’s pharmaceutical reforms that began in 2015 [1]. Through these reforms, in 2017, China became a full member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), an organization that standardizes global drug regulations [2].
To improve and speed up the consistency evaluation of generic chemical injections, the NMPA announced the following:
- All marketed generic chemical injections must be evaluated for consistency with the brand-name drug in terms of safety and efficacy. Marketing authorization holders (MAHs) should select reference formulations in accordance with the NMPA’s Catalogue for Reference Formulations of Generic Drugs apply for an R & D consistency evaluation.
- While conducting generic injection consistency evaluations, MAHs must follow relevant technical guidances. When applying for injection consistency evaluation, they must complete their application dossier in accordance with the Requirements for Application Dossiers for Consistency Evaluation of the Quality and Efficacy of Generic Chemical Injections. This is then to be submitted as supplementary information to the Center for Drug Evaluation (CDE).
- Following application, and in accordance with relevant regulations and technical guidances, CDE will review and initiate any testing or inspection required of the generic. Following this a comprehensive review opinion will be formed and if passed, the CDE will issue an approval for generic supplementary application.
The announcement noted that any other relevant issues not covered directly in it, will 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.
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References
1. GaBI Online - Generics and Biosimilars Initiative. China prioritizes drug innovation while increasing access to drugs approved abroad [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: Available from: www.gabionline.net/Generics/General/China-prioritizes-drug-innovation-while-increasing-access-to-drugs-approved-abroad
2. GaBI Online - Generics and Biosimilars Initiative. China adopts ICH guidelines and collaborates with UK [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 9]. Available from: www.gabionline.net/Guidelines/China-adopts-ICH-guidelines-and-collaborates-with-UK
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