China’s Center for Drug Evaluation (CDE) has unveiled its 86th roster of reference preparations for generic quality and consistency evaluation (GQCE), seeking public commentary until September 20, 2024. The latest draft opinion expands the list by incorporating 23 new drugs and 27 specifications, aiming to enhance the standardization and reliability of generic drugs in the market.
In addition to the inclusions, the CDE has also reported that 34 drugs did not meet the review criteria. The reasons for their exclusion were primarily related to their ineligibility to serve as reference preparations or discrepancies in approved usage and dosage within the Chinese context, resulting in a failure at the secondary review stage.
This process is a critical component of China’s ongoing efforts to ensure the quality, safety, and efficacy of generic drugs, aligning with international standards and practices.- Flcube.com
