By Fineline Cube 
China’s Center for Drug Evaluation (CDE) has selected the 94th batch of reference preparations for generic quality and consistency evaluation (GQCE) purposes. The list is open for public comment until May 30. This initiative is part of the ongoing efforts to ensure the quality and consistency of generic drugs in the Chinese market.
Draft Opinion Details
The draft opinion adds 14 originator specifications that have not yet been imported to China and updates information for 45 existing specifications. This batch aims to provide clearer guidelines and standards for the evaluation of generic drugs, enhancing the regulatory framework for drug quality.
Review Outcomes
Meanwhile, a total of 12 drugs failed to pass the review in this batch. This highlights the rigorous standards set by the CDE to ensure that only high-quality and consistent generic drugs enter the market.-Fineline Info & Tech