The Center for Drug Evaluation (CDE) in China has announced its 88th batch of reference preparations for the purpose of generic quality and consistency evaluation (GQCE). This selection is a critical step in ensuring the quality and efficacy of generic drugs within the Chinese market.
Expansion and Refinement of Reference Preparations
The latest draft opinion from the CDE includes 30 new drugs and 37 specifications for consideration in the GQCE process. This addition aims to enhance the standards by which generic drugs are evaluated for equivalence to their branded counterparts. Concurrently, 29 drugs did not meet the criteria for inclusion in this batch, with the primary reason being their ineligibility to serve as reference preparations.- Flcube.com
