The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) is currently in the process of soliciting feedback on the 88th batch of chemical generic reference preparations, with a deadline set for August 14, 2024. This initiative is part of the ongoing efforts to standardize and ensure the quality of generic drugs in the Chinese market.
The latest batch features 12 new specifications that have never been included in previous lists, as well as 42 additional specifications that have been added for consideration. However, the review process has not been favorable for all, with a total of 29 specifications failing to meet the criteria. The reasons for the failure include the absence of a reference preparation status and an inability to demonstrate significant clinical value, among other factors.- Flcube.com
