The Center for Drug Evaluation (CDE) has released the 74th batch of chemical generic reference preparations, marking a significant update to the list with the addition of 24 new specifications and an increment of 34 specifications in total.
Review Outcomes and Specification Details
Eleven specifications did not meet the review criteria due to the absence of reference preparation status. Furthermore, some drugs were not approved as they failed to demonstrate clinical advantages over existing drugs in the Chinese market. A number of these drugs also did not pass the reexamination process.
Implications for the Generic Drug Market
The latest batch of reference preparations from the CDE is expected to have a substantial impact on the generic drug market, providing clarity and standards for drug manufacturers. The addition of new specifications aims to enhance the quality, efficacy, and safety of generic drugs available to patients.-Fineline Info & Tech
