China’s Center for Drug Evaluation (CDE) has released the 92nd batch of reference preparations for generic quality and consistency evaluation (GQCE). This initiative is part of the ongoing efforts to ensure the quality and consistency of generic drugs in the market.
New Additions
The latest batch includes 33 new drugs and 9 additional specifications. These reference preparations will serve as benchmarks for the evaluation of generic drugs, ensuring they meet the required standards for quality and consistency.
Review Outcomes
In this round, a total of 30 drugs failed to pass the review. Reasons for failure included ineligibility to serve as reference preparations and an inability to provide sufficient clinical data to support their approval. This underscores the rigorous standards set by the CDE to ensure the safety and efficacy of generic drugs.-Fineline Info & Tech
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