China’s CDE Announces 95th Batch of Reference Preparations for Public Comment

China's CDE Announces 95th Batch of Reference Preparations for Public Comment

China’s Center for Drug Evaluation (CDE) has released the 95th batch of reference preparations for generic quality and consistency evaluation (GQCE) purposes. The list is open for public comment until July 17.

Draft Opinion Details
The draft opinion includes 18 new originator specifications and updates information for 37 existing specifications. Additionally, 20 drugs failed to pass the review.-Fineline Info & Tech