By Fineline Cube 
China’s Center for Drug Evaluation (CDE) has released the 93rd batch of reference preparations for generic quality and consistency evaluation (GQCE). This latest update includes the addition of 29 new specifications and updates to 55 existing specifications. However, 14 drugs failed to pass the review process.
Details of the Release
The recent announcement by the CDE highlights the ongoing efforts to ensure the quality and consistency of generic drugs in China. The inclusion of new specifications and updates to existing ones reflects the dynamic nature of the pharmaceutical landscape and the regulatory body’s commitment to maintaining high standards for drug evaluation.
Implications for the Pharmaceutical Industry
For pharmaceutical companies, the CDE’s updates serve as crucial guidelines for the development and approval of generic drugs. The failure of 14 drugs to pass the review underscores the rigorous standards that generics must meet to gain approval, emphasizing the importance of adhering to these guidelines to ensure patient safety and drug efficacy.-Fineline Info & Tech