China’s Center for Drug Evaluation (CDE) has selected the 90th batch of reference preparations for generic quality and consistency evaluation (GQCE) purposes. This batch adds 43 new drugs and 9 specifications to the list, reflecting the ongoing efforts to enhance the quality and consistency of generic drugs in the market.
Review Process and Rejections
In this batch, a total of 18 drugs failed to pass the review. The reasons for failure include ineligibility to act as reference, lack of clinical advantage, and inability to prove the adequacy of clinical data. These rejections highlight the stringent criteria and rigorous evaluation process employed by the CDE to ensure that only high-quality and effective drugs are included as reference preparations.
Significance of GQCE
The GQCE program is crucial for ensuring that generic drugs meet the same high standards of quality and efficacy as their reference counterparts. By selecting and approving reference preparations, the CDE supports the development and availability of reliable generic medications, benefiting both healthcare providers and patients.-Fineline Info & Tech
