The National Drug Review Center issued: Chemical generic injection overfilling research technical guidance notice.
Release time:
2024-10-25
Durst DST Regulation Group noted that on July 05, 2024, the Drug Evaluation Center of the State Drug Administration (hereinafter referred to as CDE), in order to further clarify the technical requirements for overfilling research on chemical generic injections and improve the evaluation standard system for chemical generic injections, according to the work deployment of the State Drug Administration, the Drug Examination Center organized and formulated the "Technical Guidelines for Overfilling Research on Chemical Generic Injections", which will be implemented from July 5, 2024
Durst DST Regulation Group noted that on July 05, 2024, the Drug Evaluation Center of the State Drug Administration (hereinafter referred to as CDE), in order to further clarify the technical requirements for overfilling research on chemical generic injections and improve the evaluation standard system for chemical generic injections, according to the work deployment of the State Drug Administration, the Drug Examination Center organized and formulated the "Technical Guidelines for Overfilling Research on Chemical Generic Injections", which will be implemented from July 5, 2024
Overfilling of injections refers to the volume or weight of the drug in each container that is appropriately increased compared with the marked amount to ensure that the actual dosage of the drug meets the dosage specified in the instructions. In order to improve the pharmaceutical research and application data requirements for overfilling of chemical generic drug injections, this guiding principle is formulated in combination with the current situation of research and development and production of generic drugs at home and abroad. This guideline applies only to marketing applications and post-marketing related change studies (e. g., changes that may affect filling volume, etc.) for chemical generic injections packaged in ampoules and vials, and does not apply to injections in other packaging forms (e. g., pre-encased packaging systems, IV bags, etc.). This guidance represents only the current understanding of the drug regulatory authorities on this issue and is intended to provide guidance on the marketing application and related research of newly declared chemical generic drug injections. With the continuous improvement of relevant laws and regulations and the improvement of technical requirements for drug research, the relevant contents of these guidelines will be continuously improved and updated.
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